Natural Microbiota Restoration After C-section Birth (RESTORE)

Retablissement Du Microbiote Naturel Apres Naissance Par Cesarienne

The proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the 1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%. The use of C-section continues to grow in every countries of the world despite that current knowledge leads us to think that the vaginal birth, retained through millennia during mammalian evolution, guarantees the implementation of the best suited intestinal microbiota to build immunity and beneficial protective functions under the balanced mutual association between the host and its microbiota. Oral administration of a previously impregnated swab, by vaginal and maternal perineal secretions, following birth by planned C-section, would restore the normal development of the newborn intestinal microbiota mimicking exposure to these secretions during vaginal delivery.

The expected benefit is the establishment of a rich and diverse microbiota in individuals in the intervention group and by extension improving the overall health of these individuals.

Study Overview

• Status: Completed
• Conditions: Insufficient Intestinal Microbiota Diversity After C-section Birth
• Intervention / Treatment: Other: perineal impregnated swab; Other: clean swab

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Service de Gynécologie-Obstétrique, Groupe Hospitalier Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• over the age of legal majority
• delivery by planned C-section at term or vaginal delivery at term
• registered at a social security service

Exclusion Criteria:

• HIV or other STD patients
• immunocompromised patients
• known streptococcus B carriers
• known vaginal or perineal herpes infections
• chronic disease patients (obesity, diabetes, IBD)
• IMC before pregnancy > 30 kg/m²
• antibiotic treatments one month before delivery
• emergency C-section
• Premature delivery (<37 amenorrhea weeks)
• hospitalized for more than one week before delivery
• known HVC infections
• for the newborns: every diagnosed anomaly
• patients who do not understand the research procedures or those that are institutionalized, or those unable to give informed consent
• patients deprived of ther liberty by legal or administrative decisions
• patients under an exclusion period from another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 75 children born by planned C-section will be exposed to the perineal microbiota of their mothers through perineal impregnated swab.	Other: perineal impregnated swab; After planned C-section birth, newborns will suck on previously impregnated swab by perineal and vaginal mother secretions.
Placebo Comparator: Placebo Group; 75 children born by planned C-section will be exposed to clean swab.	Other: clean swab; After planned C-section birth, newborns will suck on clean swab.
No Intervention: Control Group; 75 children born vaginally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diversity of the intestinal microbiota	Intestinal microbiota diversity will be evluated through metagenomics.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health status	Health status of the newborn will be evaluated through questionnaries.	1 year

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Jacky Nizard, MD, PhD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2016
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Microbiota; C-section
• Other Study ID Numbers: C14-70; 2015-A00586-43 (Registry Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No