Lactobacillus Reuteri DSM17938 in C-Section Infants

NCT03834415 | Completed DMC

• 1 other identifier: CSUB0153
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

RCT designed to evaluate the impact of Lactobacillus reuteri DSM17938 to modify gut microbiota in children delivered by C-section

Conditions

C-section

Outcome Measures

Primary Outcomes (3)

• Changes on fecal microbiome diversity at day 14

  Changes on diversity evaluated by Shannon Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention

  14 days

• Changes on fecal microbiome abundance at day 14

  Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention

  14 days

• Changes on fecal microbiome stability at day 14

  Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention

  14 days

Secondary Outcomes (5)

• Changes on fecal microbiome diversity at day 7, 30 and 60

  7, 30 and 60 days

• Changes on fecal microbiome abundance at day 7, 30 and 60

  7, 30 and 60 days

• Changes on fecal microbiome stability at day 7, 30 and 60

  7, 30 and 60 days

• Changes on Salivary IgA levels

  7, 30 and 60 days

• Frequency of Adverse Event

  30 days

Study Arms (2)

Lactobacillus reuteri DSM17038

EXPERIMENTAL

Lactobacillus reuteri DSM17038, 1x108 CFU once a day for 30 days

Dietary Supplement: Lactobacillus reuteri DSM17038

Placebo probiotics

PLACEBO COMPARATOR

Placebo for probiotics, pols drops similar in consistency and flavor as experimental product

Other: Placebo for Probiotics

Interventions

Lactobacillus reuteri DSM17038 DIETARY_SUPPLEMENT

Oil drops of L. reuteri containing 1x10\>8 CFU

Lactobacillus reuteri DSM17038

Placebo for Probiotics OTHER

Oil drops mimicking in consistency and flavor to experimental product

Placebo probiotics

Eligibility Criteria

• Age: 12 Hours - 36 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age \>37weeks +0 days and \<39 weeks +0 days
• Birth weight appropriate for gestational age (AGA) or Large for Gestational Age (LGA)
• Apgar score 8 or greater
• Children will receive more than 50% of the feeding occasions with human breastmilk
• Mothers will have the intention to exclusively or predominantly breastfeed the subject. On the diary report form mother will report day by day the frequency of human lactation and the frequency and amount of infant formula.
• Readiness and the opportunity for parents to fill out a study diary, questionnaires.
• Parent(s) are willing to postpone major changes in the infant feeding mode, and
• Written informed consent from parents

You may not qualify if:

• Older than 24 hours after birth when given the first dose of investigational product
• Any kind of chronic or acute diseases during pregnancy that can modify fecal microbiota in children, e.g. gestational diabetes, pre-clampsia, gastrointestinal disease
• Congenital malformations or anomalies
• Maternal use of antibiotics from gestational week 33 and throughout the study period.
• Maternal use of probiotics from gestational week 33 and throughout the study period.
• Infant use of antibiotics throughout the study period.
• Infant use of probiotics throughout the study period, including infant formula and/or supplementation.
• Infants carrying out general anesthesia
• Meconium aspiration syndrome
• History of premature disruption of membranes for \>24h
• Participation in other clinical trials

Sponsors & Collaborators

• Innovacion y Desarrollo de Estrategias en Salud: lead
• BioGaia AB: collaborator

Study Sites (1)

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, Tlalpan, 14080, Mexico

Location

Related Publications (5)

• Chandel DS, Perez-Munoz ME, Yu F, Boissy R, Satpathy R, Misra PR, Sharma N, Chaudhry R, Parida S, Peterson DA, Gewolb IH, Panigrahi P. Changes in the Gut Microbiota After Early Administration of Oral Synbiotics to Young Infants in India. J Pediatr Gastroenterol Nutr. 2017 Aug;65(2):218-224. doi: 10.1097/MPG.0000000000001522.

  PMID: 28121648 BACKGROUND

• Garcia Rodenas CL, Lepage M, Ngom-Bru C, Fotiou A, Papagaroufalis K, Berger B. Effect of Formula Containing Lactobacillus reuteri DSM 17938 on Fecal Microbiota of Infants Born by Cesarean-Section. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):681-687. doi: 10.1097/MPG.0000000000001198.

  PMID: 27035371 BACKGROUND

• Nitert MD, Barrett HL, Foxcroft K, Tremellen A, Wilkinson S, Lingwood B, Tobin JM, McSweeney C, O'Rourke P, McIntyre HD, Callaway LK. SPRING: an RCT study of probiotics in the prevention of gestational diabetes mellitus in overweight and obese women. BMC Pregnancy Childbirth. 2013 Feb 25;13:50. doi: 10.1186/1471-2393-13-50.

  PMID: 23442391 BACKGROUND

• Jansman AJ, Zhang J, Koopmans SJ, Dekker RA, Smidt H. Effects of a simple or a complex starter microbiota on intestinal microbiota composition in caesarean derived piglets. J Anim Sci. 2012 Dec;90 Suppl 4:433-5. doi: 10.2527/jas.53850.

  PMID: 23365401 BACKGROUND

• Kuitunen M, Kukkonen K, Juntunen-Backman K, Korpela R, Poussa T, Tuure T, Haahtela T, Savilahti E. Probiotics prevent IgE-associated allergy until age 5 years in cesarean-delivered children but not in the total cohort. J Allergy Clin Immunol. 2009 Feb;123(2):335-41. doi: 10.1016/j.jaci.2008.11.019. Epub 2009 Jan 8.

  PMID: 19135235 BACKGROUND

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Pedro Gutierrez Castrellon, MD, MSc, DSc

  Hospital General Dr. Manuel Gea Gonzalez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding process will be structured centrally. The oil drops of active are contained in an ambar flask. Placebo consistency, smell, flavor and container are identical to active product
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Translational Research Center for Mother-Child Health

Model Details: RCT two arms to evaluate the safety and efficacy of L. reuteri vs. placebo to modulate the microbiome gut profile in newborn babies delivered by C-section

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 8, 2019
• Study Start: February 8, 2019
• Primary Completion: April 18, 2019
• Study Completion: June 18, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: January 2019, for 12 months
• Access Criteria: IPD sharing access will be available for all investigators who want to do secondary analysis, always giving credits to principal investigators and owner of this research

Locations

ME (1)