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Vaginal Seeding for Allergies and Asthma in C-section Infants

Phase < 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Infants with complications during delivery, such that the infant requires more than the standard neonatal resuscitation after delivery

Evidence of an active sexually transmitted infection (STI) (e.g., primary herpes or genital warts, or trichomonas), yeast infection, or vaginosis on the day of delivery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up infants at 3 months and 12 months of age (=month 3 and -12 visits)

Summary

This trial is looking to see if it's effective to swab C-section babies with a gauze pad that has been dipped in the mother's vagina just after birth.

Who is the study for?

This trial is for pregnant women planning a C-section who understand the study and consent to participate. Their babies must have a relative with allergies or asthma, but can't join if there's labor before the C-section, water breaks early, high vaginal pH, or certain infections like HIV or hepatitis. Moms with serious health issues or on certain medications are also excluded.

What is being tested?

The study tests whether exposing C-section newborns to their mother's vaginal bacteria (vaginal seeding) might reduce allergy and asthma risk compared to placebo seeding or standard care. It explores how this exposure could influence the baby’s immune system by comparing these three approaches.

What are the potential side effects?

Potential side effects aren't specified for this trial since it involves natural bacterial exposure rather than drugs; however, there may be risks associated with handling and transferring maternal bacteria which will be monitored throughout the study.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My baby needed extra help beyond normal care after birth.

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I do not have an active STI, yeast infection, or vaginosis on the day of delivery.

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I have a history of inflammatory bowel disease.

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I am a mother with a serious long-term health condition during my pregnancy.

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I used experimental drugs in the last 3 months of my pregnancy.

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I have had diabetes or diabetes during pregnancy.

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I have taken antibiotics in the last trimester of my current pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ infants at 3 months and 12 months of age (=month 3 and -12 visits)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~infants at 3 months and 12 months of age (=month 3 and -12 visits)

This trial's timeline: 3 weeks for screening, Varies for treatment, and infants at 3 months and 12 months of age (=month 3 and -12 visits) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Presence of Sensitization to at Least One Food Allergen at 12 months of age - by Treatment Group

Secondary study objectives

Level of Allergen-Specific Atopy at 12 months of age - by Treatment Group

Level of Combined Allergen-Specific Atopy at 12 Months of Age - by Treatment Group

Number of Food Allergens and Aeroallergens Each Infant is Sensitized to at 12 Months of Age-by Treatment Group

+3 more

Other study objectives

EXPLORATORY: Comparison by Treatment Group in Bacterial Composition of the Infant Microbiome

EXPLORATORY: Comparison by Treatment Group in Fungal Composition of the Infant Microbiome

EXPLORATORY: Comparison by Treatment Group in Immunomodulatory Influences of the Fecal Metabolome

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: C-section -Vaginal seedingExperimental Treatment1 Intervention

Pregnant women who undergo C-section and (neonate) vaginal seeding. Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with gauze containing their mother's vaginal microbiota just after delivery.

Group II: C-section - Placebo SeedingExperimental Treatment1 Intervention

Pregnant women who undergo C-section and (neonate) placebo seeding. Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with sterile gauze (placebo).

Group III: standard careActive Control1 Intervention

Pregnant women who undergo spontaneous vaginal delivery (of neonate) . Pregnant women who undergo spontaneous vaginal delivery and (neonate) receives standard care.

0 / 7Eligibility criteria met