Trial Outcomes & Findings for Effects of Probiotics in Immune System of Healthy Adults (NCT NCT01479543)
NCT ID: NCT01479543
Last Updated: 2014-09-05
Results Overview
Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the "number of participants" was tolerant to the intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
4 weeks of the treatments. Daily recorded.
Results posted on
2014-09-05
Participant Flow
Participant milestones
| Measure |
Group A
Volunteers are given strain CNCM I-4034.
Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group B
Volunteers receive Probiotic CNCM I-4035.
Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group C
Volunteers are given Probiotic CNCM I-4036.
Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group D
Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group E
Volunteers receive a placebo.
Placebo capsule: Placebo capsule for 28 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
21
|
20
|
21
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Probiotics in Immune System of Healthy Adults
Baseline characteristics by cohort
| Measure |
Group B
n=20 Participants
Volunteers receive Probiotic CNCM I-4035.
Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group C
n=20 Participants
Volunteers are given Probiotic CNCM I-4036.
Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group D
n=20 Participants
Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group E
n=20 Participants
Volunteers receive a placebo.
Placebo capsule: Placebo capsule for 28 days.
|
Total
n=100 Participants
Total of all reporting groups
|
Group A
n=20 Participants
Volunteers are given strain CNCM I-4034.
Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 5.7 • n=107 Participants
|
29.4 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
30.3 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
28.5 years
STANDARD_DEVIATION 7.6 • n=31 Participants
|
28.78 years
STANDARD_DEVIATION 1.22 • n=30 Participants
|
28.7 years
STANDARD_DEVIATION 5 • n=99 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
100 Participants
n=30 Participants
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
54 Participants
n=30 Participants
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
46 Participants
n=30 Participants
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
20 participants
n=107 Participants
|
20 participants
n=206 Participants
|
20 participants
n=7 Participants
|
20 participants
n=31 Participants
|
100 participants
n=30 Participants
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 weeks of the treatments. Daily recorded.Population: Calculation of simple size was based on the variance in the probiotic strain count (log strain CFU/g) in feces and a difference of 25% compared with the placebo. alfa: 0.05 power 90%
Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the "number of participants" was tolerant to the intervention.
Outcome measures
| Measure |
Group A
n=20 Participants
Volunteers are given strain CNCM I-4034.
Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group B
n=20 Participants
Volunteers receive Probiotic CNCM I-4035.
Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group C
n=20 Participants
Volunteers are given Probiotic CNCM I-4036.
Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group D
n=20 Participants
Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group E
n=20 Participants
Volunteers receive a placebo.
Placebo capsule: Placebo capsule for 28 days.
|
|---|---|---|---|---|---|
|
Gastrointestinal Tolerance After Probiotic Consumption.
|
20 participants
|
20 participants
|
20 participants
|
20 participants
|
20 participants
|
SECONDARY outcome
Timeframe: At Time zero, after 4 weeks, and 2 later.Effect on the systemic and adaptive immune system. This will be measured by means of lymphocite populations and plasma cytokine present on blood, IgAs on serum (at zero time and after four weeks of treatment), IgAs on saliva and faeces and AGCC (at zero time and after four weeks and two more weeks). Gastrointestinal effects will be measured by means of gastrointestinal symptoms record and frequency and aspect of faeces, during the treatment and the following two weeks (wash-out period).
Outcome measures
Outcome data not reported
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=20 participants at risk
Volunteers are given strain CNCM I-4034.
Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group B
n=20 participants at risk
Volunteers receive Probiotic CNCM I-4035.
Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group C
n=20 participants at risk
Volunteers are given Probiotic CNCM I-4036.
Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group D
n=20 participants at risk
Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days.
|
Group E
n=20 participants at risk
Volunteers receive a placebo.
Placebo capsule: Placebo capsule for 28 days.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain, nausea and vomiting, hard stools, acid regurgitation, eructation...
|
0.00%
0/20 • Adverse events were collected during the first washout (15 days) intervention period (28 days) and second wasout period (15 days). The assessment was performed using Gastrointestinal Symptom Rating Scale questionnaire (GSRS)
|
0.00%
0/20 • Adverse events were collected during the first washout (15 days) intervention period (28 days) and second wasout period (15 days). The assessment was performed using Gastrointestinal Symptom Rating Scale questionnaire (GSRS)
|
0.00%
0/20 • Adverse events were collected during the first washout (15 days) intervention period (28 days) and second wasout period (15 days). The assessment was performed using Gastrointestinal Symptom Rating Scale questionnaire (GSRS)
|
0.00%
0/20 • Adverse events were collected during the first washout (15 days) intervention period (28 days) and second wasout period (15 days). The assessment was performed using Gastrointestinal Symptom Rating Scale questionnaire (GSRS)
|
0.00%
0/20 • Adverse events were collected during the first washout (15 days) intervention period (28 days) and second wasout period (15 days). The assessment was performed using Gastrointestinal Symptom Rating Scale questionnaire (GSRS)
|
Additional Information
Esther Matencio Hilla
Hero Institute for Infant Nutrition
Phone: +0034 968 89 89 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.
- Publication restrictions are in place
Restriction type: OTHER