N/A
Completed N=103
Effects of Probiotics in Immune System of Healthy Adults
Conditions Influencing Health Status
Source: ClinicalTrials.gov NCT01479543 ↗
Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Gastrointestinal Tolerance After Probiotic Consumption. — 20; 20; 20; 20 participants
Summary
The present report describes the design of a clinical trial performed on healthy adult individuals to check whether the daily intake of the new Hero strains contribute to intestinal colonization, under safe and tolerable conditions, with a positive contribution to health and wellbeing of healthy individuals.
Daily intake of one or several probiotic strains, (CNCM I-4034, CNCM I-4035, CNCM I-4036), increases intestinal microbiota in healthy adults, being safe and well tolerated. The regular intake has positive effects on the gastrointestinal and immune system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gastrointestinal Tolerance After Probiotic Consumption. |
20; 20; 20; 20; 20 | — |
| SECONDARY Gastrointestinal and Immune Effects of Probiotics Consumption. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Healthy adult
- Age: 18-50 years
- Normal defecation
- Normal blood parameters
- Body Mass Index: 18-30
Exclusion Criteria
- Pregnancy
- Lactation
- Antibiotic treatment
- Gastrointestinal disease
- Diarrhoea
- Constipation
- Diabetes
- Abnormal blood pressure
- Allergy
- Smoker
Data sourced from ClinicalTrials.gov (NCT01479543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.