CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 103 enrolled
Drug / intervention
Probiotic CNCM I-4034 +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01479543
NCT01479543N/ACompleted
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Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults

Hero Institute for Infant Nutrition·interventional·Posted Nov 24, 2011·Updated Sep 5, 2014

In Brief

A clinical study evaluating Probiotic CNCM I-4034, Probiotic CNCM I-4035, and 3 other interventions for Conditions Influencing Health Status. Completed, enrolled 103 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConditions Influencing Health Status
CountriesSpain
CollaboratorsUniversidad de Granada, University of Valencia, Universidad de Murcia

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2011
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.6 years ago

Interventions

Probiotic CNCM I-4034other

Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.

Probiotic CNCM I-4035other

9x10E9 cfu (colony forming unit) per day during 28 days.

Probiotic CNCM I-4036other

9x10E9 cfu (colony forming unit) per day during 28 days.

Probiotics CNCM I-4035 and CNCM I-4036other

9x10E9 cfu (colony forming unit) per day during 28 days.

Placeboother

Placebo capsule for 28 days.