Trial Outcomes & Findings for Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy (NCT NCT05138757)
NCT ID: NCT05138757
Last Updated: 2026-03-09
Results Overview
To determine the proportion of subjects who met the primary endpoint by tolerating at least 2044 mg cumulative peanut protein with no more than mild symptoms during the 12-month DBPCFC.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
At the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
Results posted on
2026-03-09
Participant Flow
Subjects were screened and enrolled at the University of Chicago.
Twenty-two participants provided informed consent. Prior to assignment, two participants were determined to be ineligible because they did not demonstrate a reaction to peanut during the double-blind, placebo-controlled oral food challenge. The remaining 20 participants were enrolled and assigned.
Participant milestones
| Measure |
Fiber
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Fiber
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy
Baseline characteristics by cohort
| Measure |
Fiber
n=9 Participants
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
n=11 Participants
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 4-6 years
|
1 Participants
n=68 Participants
|
6 Participants
n=69 Participants
|
7 Participants
n=137 Participants
|
|
Age, Customized
Age · 7-9 years
|
2 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Age, Customized
Age · 10-12 years
|
1 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
|
Age, Customized
Age · 13-15 years
|
3 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
|
Age, Customized
Age · 16-17 years
|
2 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
3 Participants
n=137 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=68 Participants
|
4 Participants
n=69 Participants
|
8 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=68 Participants
|
7 Participants
n=69 Participants
|
12 Participants
n=137 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
6 Participants
n=68 Participants
|
7 Participants
n=69 Participants
|
13 Participants
n=137 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
0 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=68 Participants
|
11 Participants
n=69 Participants
|
20 Participants
n=137 Participants
|
|
Peanut skin prick test wheal size
|
15.0 mm
STANDARD_DEVIATION 5.07 • n=68 Participants
|
16.73 mm
STANDARD_DEVIATION 11.16 • n=69 Participants
|
15.95 mm
STANDARD_DEVIATION 8.78 • n=137 Participants
|
PRIMARY outcome
Timeframe: At the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).To determine the proportion of subjects who met the primary endpoint by tolerating at least 2044 mg cumulative peanut protein with no more than mild symptoms during the 12-month DBPCFC.
Outcome measures
| Measure |
Fiber
n=9 Participants
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
n=11 Participants
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
|---|---|---|
|
The Proportion of Subjects Mildly Symptomatic or Less at the 12 Month DBPCFC
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From first study intervention through the final exit food challenge visit, up to 15 months.• To determine the proportion of subjects who experience dose related GI side effects during oral immunotherapy.
Outcome measures
| Measure |
Fiber
n=9 Participants
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
n=11 Participants
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
|---|---|---|
|
The Proportion of Subjects Who Experience Dose Related GI Side Effects During Oral Immunotherapy
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From first study intervention through the final exit food challenge visit, up to 15 months.• To determine the proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy
Outcome measures
| Measure |
Fiber
n=9 Participants
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
n=11 Participants
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
|---|---|---|
|
The Proportion of Subjects Who Experience Hypersensitivity Reactions (Other Than GI) During Oral Immunotherapy
|
3 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).Population: The number of participants analyzed differs from the overall number assigned to each arm because not all participants provided stool samples at every study timepoint. Missing butyrate measurements reflect participant withdrawal or loss to follow-up prior to stool collection at later visits. Analyses were conducted using available samples at each timepoint.
Fecal samples were collected at each study time point and analyzed for butyrate concentration using metabolomic profiling. Results are reported in millimolar (mM).
Outcome measures
| Measure |
Fiber
n=9 Participants
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
n=11 Participants
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
|---|---|---|
|
Fecal Butyrate Concentration (mM)
Baseline
|
18.45 mM
Standard Deviation 12.25
|
21.02 mM
Standard Deviation 13.47
|
|
Fecal Butyrate Concentration (mM)
Visit 4 (After 1 month of fiber or placebo supplementation)
|
15.64 mM
Standard Deviation 12.30
|
15.94 mM
Standard Deviation 9.98
|
|
Fecal Butyrate Concentration (mM)
Visit 16 (At the exit double-blind, placebo-controlled oral food challenge)
|
20.80 mM
Standard Deviation 24.15
|
18.55 mM
Standard Deviation 21.52
|
|
Fecal Butyrate Concentration (mM)
Change from baseline (week 4)
|
-5.93 mM
Standard Deviation 17.67
|
-6.37 mM
Standard Deviation 15.31
|
|
Fecal Butyrate Concentration (mM)
Change from baseline (week 16)
|
-1.51 mM
Standard Deviation 21.42
|
-3.31 mM
Standard Deviation 25.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).Population: The number of participants analyzed differs from the overall number assigned to each arm because not all participants provided blood samples at every study timepoint. Missing measurements reflect participant withdrawal or loss to follow-up prior to blood collection at later visits. Analyses were conducted using available samples at each timepoint.
• To determine if a change exists in peanut specific Immunoglobulin E (IgE) levels
Outcome measures
| Measure |
Fiber
n=9 Participants
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
n=11 Participants
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
|---|---|---|
|
Change in Peanut Specific Immunoglobulin E (IgE) Levels
Visit 16 (At the exit double-blind, placebo-controlled oral food challenge)
|
12.47 kUA/L
Standard Deviation 18.90
|
57.72 kUA/L
Standard Deviation 38.17
|
|
Change in Peanut Specific Immunoglobulin E (IgE) Levels
Change from baseline (visit 4)
|
7.89 kUA/L
Standard Deviation 18.86
|
4.21 kUA/L
Standard Deviation 17.03
|
|
Change in Peanut Specific Immunoglobulin E (IgE) Levels
Change from baseline (visit 16)
|
-2.01 kUA/L
Standard Deviation 3.12
|
-10.85 kUA/L
Standard Deviation 28.61
|
|
Change in Peanut Specific Immunoglobulin E (IgE) Levels
Baseline
|
17.31 kUA/L
Standard Deviation 18.93
|
69.34 kUA/L
Standard Deviation 41.58
|
|
Change in Peanut Specific Immunoglobulin E (IgE) Levels
Visit 4 (After 1 month of fiber or placebo supplementation)
|
25.21 kUA/L
Standard Deviation 32.31
|
73.55 kUA/L
Standard Deviation 39.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).Population: The number of participants analyzed differs from the overall number assigned to each arm because not all participants provided blood samples at every study timepoint. Missing measurements reflect participant withdrawal or loss to follow-up prior to blood collection at later visits. Analyses were conducted using available samples at each timepoint.
• To determine if a change exists in peanut specific Immunoglobulin G4 (IgG4) levels
Outcome measures
| Measure |
Fiber
n=9 Participants
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
n=11 Participants
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
|---|---|---|
|
Change in Peanut Specific Immunoglobulin G4 (IgG4) Levels
Baseline
|
0.41 kUA/L
Standard Deviation 0.20
|
1.58 kUA/L
Standard Deviation 1.98
|
|
Change in Peanut Specific Immunoglobulin G4 (IgG4) Levels
Visit 4 (After 1 month of fiber or placebo supplementation)
|
0.57 kUA/L
Standard Deviation 0.40
|
2.21 kUA/L
Standard Deviation 3.33
|
|
Change in Peanut Specific Immunoglobulin G4 (IgG4) Levels
Visit 16 (At the exit double-blind, placebo-controlled oral food challenge)
|
2.20 kUA/L
Standard Deviation 2.25
|
8.31 kUA/L
Standard Deviation 8.78
|
|
Change in Peanut Specific Immunoglobulin G4 (IgG4) Levels
Change from Baseline (Visit 4)
|
0.09 kUA/L
Standard Deviation 0.20
|
0.54 kUA/L
Standard Deviation 1.30
|
|
Change in Peanut Specific Immunoglobulin G4 (IgG4) Levels
Change from Baseline (Visit 16)
|
1.84 kUA/L
Standard Deviation 2.23
|
8.61 kUA/L
Standard Deviation 8.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).Population: Skin prick test wheal diameters are presented as mean (SD). The number of participants analyzed varies by timepoint due to participant withdrawal or missing SPT measurements at later study visits. Analyses were conducted using available data at each visit.
• To determine if a change exists in peanut skin prick test mean wheal diameter
Outcome measures
| Measure |
Fiber
n=9 Participants
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
n=11 Participants
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
|---|---|---|
|
Change in Peanut Skin Prick Test Mean Wheal Diameter
Baseline
|
15.00 mm
Standard Deviation 5.07
|
16.73 mm
Standard Deviation 11.16
|
|
Change in Peanut Skin Prick Test Mean Wheal Diameter
Visit 4 (After 1 month of fiber or placebo supplementation)
|
18.67 mm
Standard Deviation 18.84
|
18.00 mm
Standard Deviation 14.12
|
|
Change in Peanut Skin Prick Test Mean Wheal Diameter
Visit 16 (At the exit double-blind, placebo-controlled oral food challenge)
|
5.20 mm
Standard Deviation 3.63
|
6.78 mm
Standard Deviation 3.70
|
|
Change in Peanut Skin Prick Test Mean Wheal Diameter
Change from Baseline (Visit 4)
|
3.67 mm
Standard Deviation 15.26
|
1.27 mm
Standard Deviation 16.20
|
|
Change in Peanut Skin Prick Test Mean Wheal Diameter
Change from Baseline (Visit 16)
|
-12.80 mm
Standard Deviation 3.27
|
-11.89 mm
Standard Deviation 8.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).Population: The number of participants analyzed for peanut Ara h 2 differs from the number assigned to each study arm because Ara h 2 measurements were not available for all participants at all study visits. Missing values reflect participant withdrawal, missed follow-up visits, or incomplete laboratory testing. Analyses were performed using available data at each timepoint.
• To determine if a change exists in peanut component levels (peanut Ara h 2)
Outcome measures
| Measure |
Fiber
n=9 Participants
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
n=11 Participants
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
|---|---|---|
|
Change in Peanut Component Levels
Baseline
|
12.91 kUA/L
Standard Deviation 19.01
|
59.43 kUA/L
Standard Deviation 40.20
|
|
Change in Peanut Component Levels
Visit 4 (After 1 month of fiber or placebo supplementation)
|
22.62 kUA/L
Standard Deviation 33.86
|
66.61 kUA/L
Standard Deviation 39.97
|
|
Change in Peanut Component Levels
Visit 16 (At the exit double-blind, placebo-controlled oral food challenge)
|
13.99 kUA/L
Standard Deviation 27.97
|
45.41 kUA/L
Standard Deviation 33.79
|
|
Change in Peanut Component Levels
Change from Baseline (Visit 4)
|
9.71 kUA/L
Standard Deviation 26.81
|
7.18 kUA/L
Standard Deviation 13.57
|
|
Change in Peanut Component Levels
Change from Baseline (Visit 16)
|
-0.17 kUA/L
Standard Deviation 3.16
|
-9.53 kUA/L
Standard Deviation 18.74
|
Adverse Events
Fiber
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fiber
n=9 participants at risk
Participants received resistant potato starch fiber supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
Placebo
n=11 participants at risk
Participants received corn starch placebo supplementation before and during peanut oral immunotherapy as part of the study protocol.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
27.3%
3/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
9.1%
1/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
9.1%
1/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
2/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
27.3%
3/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
9.1%
1/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
3/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
36.4%
4/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
11.1%
1/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
18.2%
2/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
36.4%
4/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Gastrointestinal disorders
Oropharyngeal discomfort
|
22.2%
2/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
27.3%
3/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
9.1%
1/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
11.1%
1/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
0.00%
0/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
1/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
9.1%
1/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
2/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
27.3%
3/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
General disorders
Fever
|
22.2%
2/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
27.3%
3/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Skin and subcutaneous tissue disorders
Mouth pain
|
0.00%
0/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
9.1%
1/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
General disorders
Fatigue
|
11.1%
1/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
0.00%
0/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Injury, poisoning and procedural complications
Car accident
|
11.1%
1/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
0.00%
0/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
9.1%
1/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
27.3%
3/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Gastrointestinal disorders
Sore throat
|
11.1%
1/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
18.2%
2/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
0.00%
0/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Infections and infestations
Upper respiratory infection
|
11.1%
1/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
27.3%
3/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Infections and infestations
Viral conjunctivitis
|
0.00%
0/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
9.1%
1/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
9.1%
1/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
|
Immune system disorders
Allergic reaction to food
|
0.00%
0/9 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
9.1%
1/11 • From first study intervention through the final exit food challenge visit, up to 15 months.
Adverse events were collected from enrollment through end of study participation. Events were summarized by organ system and preferred term. The safety analysis population included all participants who were randomized.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place