NCT02215304 - Safety and Tolerance Study of Three Probiotic Strains in Infants | Biotech Hunter

Enrollment

221

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions

Body WeightBody HeightHead 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)"

Trial Locations (1)

28046

Hospital Universitario La Paz, Madrid