Lactobacillus Reuteri DSM17938 in C-Section Infants

C-section Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834415
• Other study ID #: CSUB0153
• Status: Completed
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: June 18, 2019

Study information

• Verified date: June 2019
• Source: Innovacion y Desarrollo de Estrategias en Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 18, 2019
• Est. primary completion date: April 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 36 Hours

Eligibility

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

Related Conditions & MeSH terms

• C-section

Intervention

Dietary Supplement:
• Lactobacillus reuteri DSM17038
Oil drops of L. reuteri containing 1x10>8 CFU

Other:
• Placebo for Probiotics
Oil drops mimicking in consistency and flavor to experimental product

Locations

Country	Name	City	State
Mexico	Hospital General Dr. Manuel Gea Gonzalez	Mexico city	Tlalpan

Sponsors (2)

Lead Sponsor	Collaborator
Innovacion y Desarrollo de Estrategias en Salud	BioGaia AB

Country where clinical trial is conducted

Mexico, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Changes on fecal microbiome diversity at day 7, 30 and 60	Changes on abundance evaluated by Channon Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention	7, 30 and 60 days
Secondary	Changes on fecal microbiome abundance at day 7, 30 and 60	Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention	7, 30 and 60 days
Secondary	Changes on fecal microbiome stability at day 7, 30 and 60	Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention	7, 30 and 60 days
Secondary	Changes on Salivary IgA levels	Levels of salivary IgA after 7,30 and 60 days after intervention	7, 30 and 60 days
Secondary	Frequency of Adverse Event	Frequency of adverse events reported after randomization and until finish the treatment (day 30)	30 days