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Lactobacillus Reuteri DSM17938 in C-Section Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834415
Recruitment Status : Completed
First Posted : February 8, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud

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

Condition or disease Intervention/treatment Phase
C-section Dietary Supplement: Lactobacillus reuteri DSM17038 Other: Placebo for Probiotics Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Other
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
Actual Study Start Date : February 8, 2019
Actual Primary Completion Date : April 18, 2019
Actual Study Completion Date : June 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lactobacillus reuteri DSM17038
Lactobacillus reuteri DSM17038, 1x108 CFU once a day for 30 days
 Dietary Supplement: Lactobacillus reuteri DSM17038
Oil drops of L. reuteri containing 1x10>8 CFU
Placebo Comparator: Placebo probiotics
Placebo for probiotics, pols drops similar in consistency and flavor as experimental product
 Other: Placebo for Probiotics
Oil drops mimicking in consistency and flavor to experimental product


Outcome Measures
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Primary Outcome Measures :
  1. Changes on fecal microbiome diversity at day 14 [ Time Frame: 14 days ]
    Changes on diversity evaluated by Shannon Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention

  2. Changes on fecal microbiome abundance at day 14 [ Time Frame: 14 days ]
    Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention

  3. Changes on fecal microbiome stability at day 14 [ Time Frame: 14 days ]
    Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention


Secondary Outcome Measures :
  1. Changes on fecal microbiome diversity at day 7, 30 and 60 [ Time Frame: 7, 30 and 60 days ]
    Changes on abundance evaluated by Channon Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention

  2. Changes on fecal microbiome abundance at day 7, 30 and 60 [ Time Frame: 7, 30 and 60 days ]
    Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention

  3. Changes on fecal microbiome stability at day 7, 30 and 60 [ Time Frame: 7, 30 and 60 days ]
    Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention

  4. Changes on Salivary IgA levels [ Time Frame: 7, 30 and 60 days ]
    Levels of salivary IgA after 7,30 and 60 days after intervention

  5. Frequency of Adverse Event [ Time Frame: 30 days ]
    Frequency of adverse events reported after randomization and until finish the treatment (day 30)


Eligibility Criteria
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Ages Eligible for Study:   up to 36 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834415


Locations
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Mexico
Hospital General Dr. Manuel Gea Gonzalez
Mexico city, Tlalpan, Mexico, 14080
Sponsors and Collaborators
Innovacion y Desarrollo de Estrategias en Salud
BioGaia AB
Investigators
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Principal Investigator: Pedro Gutierrez Castrellon, MD, MSc, DSc Hospital General Dr. Manuel Gea Gonzalez
More Information
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Publications:

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Responsible Party: Pedro Gutierrez Castrellon, Head of Translational Research Center for Mother-Child Health, Innovacion y Desarrollo de Estrategias en Salud
ClinicalTrials.gov Identifier: NCT03834415    
Other Study ID Numbers: CSUB0153
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Protocol documents and data base results will be available at international sites
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No