Safety and Tolerance Study of Three Probiotic Strains in Infants

Summary

Study to evaluate the safety and tolerance of three probiotic bacteria intake by healthy infants. Participants are divided at random and unknown to the researchers, in four groups, three of which receive one of three probiotic bacteria while the fourth group receives placebo product.

Conditions

• Body Weight
• Body Height
• Head Circumference

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium longum ssp infantis R0033

12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time. During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3\*10E9 colony forming units (CFU)

DIETARY_SUPPLEMENT

Lactobacillus helveticus R0052

12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time. During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3\*10E9 colony forming units (CFU)

DIETARY_SUPPLEMENT

Bifidobacterium bifidum R0071

12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time. During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3\*10E9 colony forming units (CFU)

DIETARY_SUPPLEMENT

Placebo

12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time. During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3\*10E9 colony forming units (CFU)

Sponsors & Collaborators

• Lallemand Health Solutions

  collaborator INDUSTRY

• ProbiSearch SL

  lead INDUSTRY

Principal Investigators

• Felix Omeñaca, MD, PhD · Hospital Universitario La Paz

Study Design

Allocation

RANDOMIZED

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

12 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2015-07-31

Completion

2015-07-31

Countries

• Spain

Study Locations