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N/A N=103 Randomized Triple-blind

Effects of Probiotics in Immune System of Healthy Adults

Conditions Influencing Health Status

Bottom Line

View on ClinicalTrials.gov: NCT01479543 ↗
Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Gastrointestinal Tolerance After Probiotic Consumption. — 20; 20; 20; 20 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Probiotic CNCM I-4034 (Other); Probiotic CNCM I-4035 (Other); Probiotic CNCM I-4036 (Other); Probiotics CNCM I-4035 and CNCM I-4036 (Other); Placebo (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Hero Institute for Infant Nutrition
Primary completion
Dec 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Gastrointestinal Tolerance After Probiotic Consumption.		 20; 20; 20; 20; 20 —
SECONDARY
Gastrointestinal and Immune Effects of Probiotics Consumption.		 — —

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.

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
View full record on ClinicalTrials.gov →

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.

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