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

NCT03204630 | Completed

• 1 other identifier: P024
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Infant Nutrition

Keywords

infant nutrition; probiotic

Outcome Measures

Primary Outcomes (1)

• Body weight gain

  Body weight gain at 12 months (grams)

  12 months versus baseline

Secondary Outcomes (10)

• Length

  1,2,4,6,9 and 12 months of age

• Body weight

  1,2,4,6,9 and 12 months of age

• Incidence of infections

  total incidence during intervention (11 months)

• Bacterial load in feces

  1,2,4,6,9 and 12 months of age

• Regurgitation

  each 2 weeks until 6 months of age and monthly until 12 months of age

Study Arms (3)

Bifido

ACTIVE COMPARATOR

Infant formula containing Bifidobacterium breve CECT7263

Dietary Supplement: Bifido

Lfer

ACTIVE COMPARATOR

Infant formula containing Lactobacillus fermentum CECT5716

Dietary Supplement: Lfer

Control

PLACEBO COMPARATOR

Standard infant formula

Other: Control

Interventions

Lfer DIETARY_SUPPLEMENT

Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716

Lfer

Bifido DIETARY_SUPPLEMENT

Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263

Bifido

Control OTHER

Standard infant formula

Control

Eligibility Criteria

• Age: 3 Weeks - 5 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosearch S.A.: lead
• Maimónides Biomedical Research Institute of Córdoba: collaborator
• Andaluz Health Service: collaborator

Study Sites (2)

Hospital Reina Sofía

Córdoba, 14004, Spain

Location

Servicio Andaluz de Salud

Granada, 10012, Spain

Location

Related Publications (1)

• Maldonado J, Gil-Campos M, Maldonado-Lobon JA, Benavides MR, Flores-Rojas K, Jaldo R, Jimenez Del Barco I, Bolivar V, Valero AD, Prados E, Penalver I, Olivares M. Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial. BMC Pediatr. 2019 Oct 21;19(1):361. doi: 10.1186/s12887-019-1753-7.

  PMID: 31630683 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: July 2, 2017
• Study Start: January 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2015
• Last Updated: July 2, 2017

Record last verified: 2016-08

Locations

ES (2)