Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk

Biosearch Life

Status: Completed

Conditions: Infant Nutrition

Treatments: Dietary Supplement: Bifido; Dietary Supplement: Lfer; Other: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03204630

P024

Details and patient eligibility

About

A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota

Enrollment: 236 patients

Sex: All

Ages: 3 to 5 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Newborn infants at term (37-42 weeks gestational age) healthy during the first month of life, for reasons unrelated to the study, abandon breastfeeding during the first month of life.
• Signature of informed parental or guardian consent.

Exclusion criteria

• Allergic to the protein in cow's milk.
• Lactose intolerant.
• Suffering from a serious metabolic disease.
• They have experienced or are experiencing some severe gastrointestinal disease.
• Receive some form of chronic medication or are receiving antibiotics at the time of capture.
• Low expectation of compliance with the study protocol.
• allergic to any group of antibiotics.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

236 participants in 3 patient groups, including a placebo group

Bifido

Active Comparator group

Description:

Infant formula containing Bifidobacterium breve CECT7263

Treatment:

Dietary Supplement: Bifido

Lfer

Active Comparator group

Description:

Infant formula containing Lactobacillus fermentum CECT5716

Treatment:

Dietary Supplement: Lfer

Control

Placebo Comparator group

Description:

Standard infant formula

Treatment:

Other: Control