Clinical trial NCT03834415: Lactobacillus Reuteri DSM17938 in C-Section Infants
Official title: Influence of Lactobacillus Reuteri DSM17938 on Early Gut Microbial Colonization in Infants Born by Caesarean Section: A Double-blinded, Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: C-section
Lead sponsor: Innovacion y Desarrollo de Estrategias en Salud
Sponsor class: OTHER
Collaborators: name: BioGaia AB
First posted: 2019-02-08
Enrollment: 69
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

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

Detailed description: RCT designed to evaluate the safety and efficacy of L. reuteri DSM17938 administrated to newborns babies to modify the fecal microbiome after 30 days of supplementation. Secondary Secondary endpoints will be evaluate the occurrence and frequency of AEs Day 0 to Day 60; The gut bacterial composition Day 7 and Day 30 as described in primary endpoint; the gut bacterial composition in infants born by c-section and supplemented with L. reuteri DSM17938 compared to the gut bacterial composition in infants born vaginally and the salivary concentration of IgA at 48h ±3h after birth and at Day 30.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* Maternal severe obesity at inclusion or at delivery evaluated using Rosso Madrones centiles
* 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

Primary outcomes:
measure: Changes on fecal microbiome diversity at day 14
timeFrame: 14 days
measure: Changes on fecal microbiome abundance at day 14
timeFrame: 14 days
measure: Changes on fecal microbiome stability at day 14
timeFrame: 14 days
Secondary outcomes:
measure: Changes on fecal microbiome diversity at day 7, 30 and 60
timeFrame: 7, 30 and 60 days
measure: Changes on fecal microbiome abundance at day 7, 30 and 60
timeFrame: 7, 30 and 60 days
measure: Changes on fecal microbiome stability at day 7, 30 and 60
timeFrame: 7, 30 and 60 days
measure: Changes on Salivary IgA levels
timeFrame: 7, 30 and 60 days
measure: Frequency of Adverse Event
timeFrame: 30 days
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Hospital General Dr. Manuel Gea Gonzalez
state: Tlalpan
Study officials:
affiliation: Hospital General Dr. Manuel Gea Gonzalez
name: Pedro Gutierrez Castrellon, MD, MSc, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.