Effects of Probiotics in Immune System of Healthy Adults

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.

Conditions

• Conditions Influencing Health Status

Interventions

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.

Sponsors & Collaborators

• Universidad de Granada

  collaborator OTHER

• University of Valencia

  collaborator OTHER

• Universidad de Murcia

  collaborator OTHER

• Hero Institute for Infant Nutrition

  lead INDUSTRY

Principal Investigators

• Pedro Abellán, PhD · Hero Institute of Infant Nutrition

Study Design

Allocation

RANDOMIZED

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2011-12-31

Completion

2012-12-31

Countries

• Spain

Study Locations