NCT01479543

Effects of Probiotics in Immune System of Healthy Adults

Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Hero Institute for Infant Nutrition · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The project will be based on a double-blind, randomized, and placebo-controlled clinical trial. It will be multi-Centre, with four groups plus a control group. The colonization performed by the strains and the modification of the intestinal microbiota will be evaluated by means of strain identification with RT-PCR equipped with specific primers, and bacterial population counting with in situ immunofluorescence techniques. The safety of strain intake will be evaluated with physical examination, blood parameters, and test son faeces to check for resistance to ampicillin and tetracycline by lactic flora. Tolerance will be evaluated by means of the record of gastrointestinal symptoms and the record of aspect and frequency of faeces. The effect on the systemic and adaptive immune system will be measured by means of lymphocyte populations and plasma cytokine present on blood, IgAs on serum, saliva and faeces. Also AGCC on faeces.

Conditions

• Conditions Influencing Health Status

Interventions

Type	Name	Description
OTHER	Probiotic CNCM I-4034	Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.
OTHER	Probiotic CNCM I-4035	9x10E9 cfu (colony forming unit) per day during 28 days.
OTHER	Probiotic CNCM I-4036	9x10E9 cfu (colony forming unit) per day during 28 days.
OTHER	Probiotics CNCM I-4035 and CNCM I-4036	9x10E9 cfu (colony forming unit) per day during 28 days.
OTHER	Placebo	Placebo capsule for 28 days.

Timeline

• Start date: 2011-11-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2011-11-24
• Last updated: 2014-09-05
• Results posted: 2014-09-05

Locations

4 sites across 1 country: Spain