Trial Outcomes & Findings for Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease (NCT NCT03058679)
NCT ID: NCT03058679
Last Updated: 2021-07-21
Results Overview
Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI \<150 in the absence of initiation or increase of any CD medications
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
197 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-07-21
Participant Flow
The study was conducted in 33 clinical sites across the United States. Enrollment in the trial occurred between September 29, 2017 and October 8, 2019.
There were 3 main reasons that participants who consented to the study were not randomized. The majority did not meet eligibility criteria. A small number withdrew or were lost to follow-up
Participant milestones
| Measure |
Specific Carbohydrate Diet
Diet: food for the diet will be provided to the participants for 6 weeks
|
Mediterranean Style Diet
Diet: food for the diet will be provided to the participants for 6 weeks
|
|---|---|---|
|
Baseline to Week 6
STARTED
|
99
|
92
|
|
Baseline to Week 6
COMPLETED
|
81
|
77
|
|
Baseline to Week 6
NOT COMPLETED
|
18
|
15
|
|
Week 6 to Week 12
STARTED
|
81
|
77
|
|
Week 6 to Week 12
COMPLETED
|
61
|
60
|
|
Week 6 to Week 12
NOT COMPLETED
|
20
|
17
|
Reasons for withdrawal
| Measure |
Specific Carbohydrate Diet
Diet: food for the diet will be provided to the participants for 6 weeks
|
Mediterranean Style Diet
Diet: food for the diet will be provided to the participants for 6 weeks
|
|---|---|---|
|
Baseline to Week 6
Lost to Follow-up
|
3
|
2
|
|
Baseline to Week 6
Change in Crohn's disease medication
|
4
|
2
|
|
Baseline to Week 6
Adverse Event
|
6
|
6
|
|
Baseline to Week 6
Withdrawal by Subject
|
4
|
3
|
|
Baseline to Week 6
Difficulty following the diet
|
0
|
2
|
|
Baseline to Week 6
Physician Decision
|
1
|
0
|
|
Week 6 to Week 12
Change in medication
|
5
|
7
|
|
Week 6 to Week 12
Adverse Event
|
4
|
3
|
|
Week 6 to Week 12
Withdrawal by Subject
|
9
|
4
|
|
Week 6 to Week 12
Difficulty following the assigned diet
|
2
|
3
|
Baseline Characteristics
Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
Baseline characteristics by cohort
| Measure |
Mediterranean Style Diet
n=92 Participants
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
Specific Carbohydrate Diet
n=99 Participants
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.0 years
n=99 Participants
|
36.0 years
n=107 Participants
|
37 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
86 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
174 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
25.1 kg/m2
n=99 Participants
|
25.6 kg/m2
n=107 Participants
|
25.3 kg/m2
n=206 Participants
|
|
Smoking status
Never
|
68 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Smoking status
Past
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Smoking status
Current
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Years since CD diagnosis
|
10 years
n=99 Participants
|
10 years
n=107 Participants
|
10 years
n=206 Participants
|
|
CD behavior
Non-stricturing, nonpenetrating
|
56 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
CD behavior
Stricturing
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
CD behavior
Penetrating
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
CD behavior
Stricturing and penetrating
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Crohn's disease distribution
Ileum alone
|
22 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Crohn's disease distribution
Colon alone
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Crohn's disease distribution
Ileum and Colon
|
53 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Crohn's disease distribution
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
History of perianal fistula
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
History of intestinal surgery
|
34 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Current use of any biologic
|
55 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Current use of immunomodulators
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Current use of oral 5-ASA
|
6 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Current use of rectal 5 ASA
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Current use of oral steroids
|
3 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Current use of rectal steroids
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of prior anti-TNF medications
0
|
28 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Number of prior anti-TNF medications
1
|
22 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Number of prior anti-TNF medications
2
|
32 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Number of prior anti-TNF medications
3
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Number of prior anti-TNF medications
4
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Prior ustekinumab
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Prior vedolizumab
|
27 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
hsCRP mg/L
|
2.5 mg/L
n=99 Participants
|
3.2 mg/L
n=107 Participants
|
2.9 mg/L
n=206 Participants
|
|
hsCRP >5 mg/L
|
28 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
fecal calprotectin (FC) ug/g
|
40.0 ug/g
n=99 Participants
|
107.5 ug/g
n=107 Participants
|
70 ug/g
n=206 Participants
|
|
fecal calprotectin (FC) >250 ug/g
|
13 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Inflammation on colonoscopy
Not performed
|
80 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Inflammation on colonoscopy
Yes
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Inflammation on colonoscopy
Probably
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Inflammation on colonoscopy
Probably not
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Inflammation on colonoscopy
No
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
FC>250 ug/g or hsCRP>5 mg/L or definite inflammation on colonoscopy
|
38 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
sCDAI (median, Q1-Q3)
|
217.7 units on a scale
n=99 Participants
|
226.0 units on a scale
n=107 Participants
|
223.0 units on a scale
n=206 Participants
|
|
CDAI (median, Q1-Q3)
|
206.8 units on a scale
n=99 Participants
|
210.0 units on a scale
n=107 Participants
|
209.5 units on a scale
n=206 Participants
|
|
Short IBDQ (median, Q1-Q3)
|
38.0 units on a scale
n=99 Participants
|
40.0 units on a scale
n=107 Participants
|
39.0 units on a scale
n=206 Participants
|
|
PROMIS measures (median, Q1-Q3)
Fatigue
|
60.4 units on a scale
n=99 Participants
|
58.9 units on a scale
n=107 Participants
|
59.6 units on a scale
n=206 Participants
|
|
PROMIS measures (median, Q1-Q3)
Pain interference
|
60.1 units on a scale
n=99 Participants
|
61.3 units on a scale
n=107 Participants
|
61.2 units on a scale
n=206 Participants
|
|
PROMIS measures (median, Q1-Q3)
Sleep disturbance
|
57.3 units on a scale
n=99 Participants
|
54.5 units on a scale
n=107 Participants
|
56.0 units on a scale
n=206 Participants
|
|
PROMIS measures (median, Q1-Q3)
Social isolation
|
48.4 units on a scale
n=99 Participants
|
47.2 units on a scale
n=107 Participants
|
47.9 units on a scale
n=206 Participants
|
|
Inflammatory back pain screen
0
|
30 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Inflammatory back pain screen
1-3
|
39 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Inflammatory back pain screen
>3
|
22 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Inflammatory back pain screen
Missing
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
AMeD Score
|
3.0 units on a scale
n=99 Participants
|
2.0 units on a scale
n=107 Participants
|
3.0 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: percentage of participants who achieved symptomatic remission at week 6
Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI \<150 in the absence of initiation or increase of any CD medications
Outcome measures
| Measure |
Mediterranean Style Diet
n=92 Participants
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
Specific Carbohydrate Diet
n=99 Participants
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
|---|---|---|
|
Percentage of Participants That Achieved Symptomatic Remission at Week 6
|
40 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: This measure includes only those whose screening fecal calprotectin (FC) was greater than 250μg/g at baseline and who had an FC results at both baseline and week 6
reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC \>250 μg/g
Outcome measures
| Measure |
Mediterranean Style Diet
n=13 Participants
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
Specific Carbohydrate Diet
n=23 Participants
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
|---|---|---|
|
Reduction in Bowel Inflammation Among Those Whose Screening Fecal Calprotectin (FC) Was Greater Than 250μg/g at Baseline and Who Had an FC Results at Both Baseline and Week 6
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 weeksAssessed by the CDAI - CDAI \<150
Outcome measures
| Measure |
Mediterranean Style Diet
n=92 Participants
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
Specific Carbohydrate Diet
n=99 Participants
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
|---|---|---|
|
Percentage of Participants That Reached Clinical Remission at Week 6
|
44 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: This measure includes only those that had a screening hsCRP \> 5mg/L and had hsCRP measured at both screening and at week 6
reduction in high-sensitivity CRP (hsCRP) to \<5 mg/L and \>50% reduction from screening among those with screening hsCRP \>5mg/L
Outcome measures
| Measure |
Mediterranean Style Diet
n=28 Participants
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
Specific Carbohydrate Diet
n=37 Participants
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
|---|---|---|
|
Percentage of Participants With a Reduction in Systemic Inflammation at Week 6
|
1 Participants
|
2 Participants
|
Adverse Events
Mediterranean Style Diet
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Specific Carbohydrate Diet
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mediterranean Style Diet
n=92 participants at risk
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
Specific Carbohydrate Diet
n=99 participants at risk
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/92 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
1.0%
1/99 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
3/92 • Number of events 3 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
1.0%
1/99 • Number of events 3 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
|
Gastrointestinal disorders
Worsening of Crohn's disease
|
0.00%
0/92 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
2.0%
2/99 • Number of events 2 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.1%
1/92 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
0.00%
0/99 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
1/92 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
0.00%
0/99 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/92 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
0.00%
0/99 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/92 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
0.00%
0/99 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
Other adverse events
| Measure |
Mediterranean Style Diet
n=92 participants at risk
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
Specific Carbohydrate Diet
n=99 participants at risk
Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.1%
13/92 • Number of events 14 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
10.1%
10/99 • Number of events 11 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
|
Gastrointestinal disorders
Diarrhea
|
7.6%
7/92 • Number of events 7 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
5.1%
5/99 • Number of events 5 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
|
Gastrointestinal disorders
Gastrointestingal disorders other - Worsening of Crohn's disease symptons
|
4.3%
4/92 • Number of events 4 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
6.1%
6/99 • Number of events 7 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.
As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place