Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.

NCT03298334 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 17-2694
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.

Conditions

Cesarean Delivery Affecting Newborn; Obesity, Childhood; Intestinal Microbiome; Microbiota; Host Microbial Interactions; Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (1)

• Adiposity

  E.g. Body mass index z-score

  2 years

Secondary Outcomes (3)

• Adverse events

  3 years

• Intestinal microbiota

  3 years

• Immune and inflammatory regulation

  3 years

Study Arms (2)

Receives Vaginal Seeding

ACTIVE COMPARATOR

Biological: Vaginal Seeding

No Vaginal Seeding

SHAM COMPARATOR

Other: No Vaginal Seeding

Interventions

Vaginal Seeding BIOLOGICAL

A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.

Receives Vaginal Seeding

No Vaginal Seeding OTHER

A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.

No Vaginal Seeding

Eligibility Criteria

• Age: 0 Days - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Scheduled for cesarean delivery at ≥ 37 weeks
• Pregnant with single fetus, in good general health, age 18 years or older
• Negative maternal testing for infections transmitted through vaginal and/or other body fluids performed as standard of care tests in early pregnancy
• Negative testing for Group B strep at 35-37 weeks gestation
• Vaginal pH ≤ 4.5 indicative of Lactobacillus-dominated vaginal microbiota
• No maternal or fetal complications that may inhibit the ability to perform microbiome restoration per protocol
• English or Spanish speaking
• Negative maternal testing for Gonorrhea, Chlamydia, Hepatitis B, Hepatitis C, Syphilis, and HIV at 35 weeks gestation or later
• Women aged 18-29 years must have a normal Pap test within 3 years
• Women aged 30-65 years must have a normal Pap test and an HPV test (co-testing) within 5 years or FDA-approved primary hrHPV testing alone within 5 years or a normal Pap test alone within 3 years
• Negative maternal testing for SARS-CoV-2 for the delivery admission performed as standard of care test at the Inova Health System.
• Infant condition after delivery requires no more than standard neonatal resuscitation\* or is otherwise medically unable to receive the full VMT procedure
• \[\*\] Standard neonatal resuscitation may include: tactile stimulation, bulb suction, oxygen without positive pressure, or drying

You may not qualify if:

• Delivery at a hospital other than Inova Health System
• Cesarean delivery scheduled for active infection that would have interfered with vaginal delivery such as genital herpetic lesions
• Rupture of membranes prior to scheduled cesarean delivery
• Bacterial vaginosis within 30 days of cesarean delivery
• Symptomatic urinary tract infection within 30 days of cesarean delivery
• Antibiotic therapy within 30 days of cesarean delivery (exclusive of medication use for prophylaxis at the time of surgery)
• Symptoms on admission suggesting Chorioamnionitis, e.g. maternal fever, fundal tenderness
• Symptoms on delivery admission of possible vaginal infection such as genital herpetic lesions
• History of genital HSV
• History positive testing for Group B strep infection
• History of a child with a diagnosis of Group B strep sepsis
• Pregnancy a result of donor egg or surrogacy
• Preexisting history of Type I or Type II Diabetes
• Maternal history of documented genital HPV infection, positive HPV testing or genital warts on physician examination
• Positive maternal testing for SARS-CoV-2 within 30 days of delivery or symptoms on admission suggesting potential Covid-19 infection

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Johns Hopkins University: collaborator
• Rutgers University: collaborator
• Inova Health Care Services: collaborator

Study Sites (1)

Inova Health System

Falls Church, Virginia, 22042, United States

RECRUITING

Related Publications (4)

• Dominguez-Bello MG, De Jesus-Laboy KM, Shen N, Cox LM, Amir A, Gonzalez A, Bokulich NA, Song SJ, Hoashi M, Rivera-Vinas JI, Mendez K, Knight R, Clemente JC. Partial restoration of the microbiota of cesarean-born infants via vaginal microbial transfer. Nat Med. 2016 Mar;22(3):250-3. doi: 10.1038/nm.4039. Epub 2016 Feb 1.

  PMID: 26828196 BACKGROUND

• Song SJ, Wang J, Martino C, Jiang L, Thompson WK, Shenhav L, McDonald D, Marotz C, Harris PR, Hernandez CD, Henderson N, Ackley E, Nardella D, Gillihan C, Montacuti V, Schweizer W, Jay M, Combellick J, Sun H, Garcia-Mantrana I, Gil Raga F, Collado MC, Rivera-Vinas JI, Campos-Rivera M, Ruiz-Calderon JF, Knight R, Dominguez-Bello MG. Naturalization of the microbiota developmental trajectory of Cesarean-born neonates after vaginal seeding. Med. 2021 Aug 13;2(8):951-964.e5. doi: 10.1016/j.medj.2021.05.003. Epub 2021 Jun 17.

  PMID: 35590169 BACKGROUND

• Hourigan SK, Dominguez-Bello MG, Mueller NT. Can maternal-child microbial seeding interventions improve the health of infants delivered by Cesarean section? Cell Host Microbe. 2022 May 11;30(5):607-611. doi: 10.1016/j.chom.2022.02.014.

  PMID: 35550663 BACKGROUND

• Namasivayam S, Tilves C, Ding H, Wu S, Domingue JC, Ruiz-Bedoya C, Shah A, Bohrnsen E, Schwarz B, Bacorn M, Chen Q, Levy S, Dominguez Bello MG, Jain SK, Sears CL, Mueller NT, Hourigan SK. Fecal transplant from vaginally seeded infants decreases intraabdominal adiposity in mice. Gut Microbes. 2024 Jan-Dec;16(1):2353394. doi: 10.1080/19490976.2024.2353394. Epub 2024 May 14.

  PMID: 38743047 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist

  National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital

  PRINCIPAL INVESTIGATOR

• Noel Mueller, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Maria Gloria Dominguez Bello, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

• Lawrence Appel, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suchitra Hourigan, MD

CONTACT

703-776-8489; suchitra.hourigan@inova.org, suchitra.hourigan@nih.gov

Shira Levy

CONTACT

703-776-8489; shira.levy@inova.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 2, 2017
• Study Start: July 1, 2018
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE

Locations

US (1)