Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

Beneo

Status: Completed

Conditions: Healthy; Infection; Microbial Colonization

Treatments: Other: Standard formula; Other: Supplemented formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04441359

Study protocol June 2008 final

Details and patient eligibility

About

The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.

Full description

The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related outcomes, as well as on gastrointestinal function and well-being in infants during the first year of life. Effects on infant growth, tolerance and on the composition of fecal microbiota were further objectives of this study. The study was conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy term infants. The two groups of the study are product group (standard infant formula supplemented with inulin-type fructans) and control group (non-supplemented standard infant formula).

Enrollment: 160 patients

Sex: All

Ages: 1 day to 4 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97)
• Healthy babies aged between 0 - 4 months of age
• Babies exclusively fed with an infant formula on enrolment into the study

Exclusion criteria

• The presence of an infection at the moment of the recruitment or 1 week before recruitment
• The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.)
• Any other diseases related to the immune system (primary immunodeficiency)
• Parents not able to comply with the study follow up (according to physician criteria)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

supplemented formula

Experimental group

Description:

Standard formula supplemented with prebiotic inulin-type fructans

Treatment:

Other: Supplemented formula

standard formula

Placebo Comparator group

Description:

Standard Formula not supplemented with prebiotic inulin-type fructans

Treatment:

Other: Standard formula