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C-Section babies get a microbiome boost to fight allergies

NCT ID NCT03567707

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether giving C-section babies a dose of their mother's vaginal bacteria can help prevent allergies and asthma. Researchers believe that babies born by C-section miss out on beneficial bacteria that help train the immune system. The study involves 114 infants at high risk for allergies and tracks whether they develop food or airborne allergies by age 1.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

114 people

The number who actually took part.

Started

Nov 2018

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant woman must be able to understand and provide informed consent; * Pregnant women with singleton pregnancies with a non-anomalous, appropriately-grown fetus; and * Atopic disease (asthma, allergic rhinoconjunctivitis, or atopic dermatitis) or food allergy in a first-degree relative of the infant to-be-delivered (for exception, see exclusion criteria\*). Exclusion Criteria: For C-Section Mothers: * In labor with evidence of cervical change prior to the scheduled C-section; * Rupture of the amniotic sac; or * Vaginal pH \> 4.5 on the day of delivery. For Vaginal Delivery Mothers: \- Use of induction agents for cervical ripening (cervical prostaglandin or Foley catheter). For All Mothers and Their Infants: * Inability or unwillingness of a participant to give written informed consent or comply with study protocol; * History of moderate to severe atopic dermatitis within the past year in the mother; * Express no intention to breastfeed; * History of diabetes mellitus or gestational diabetes mellitus; * History of inflammatory bowel disease (IBD) (e.g., Crohn's Disease or ulcerative colitis); * 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; * Evidence of prior or current hepatitis B or C infection as demonstrated by the presence of the hepatitis B surface antigen, antibody positivity against the hepatitis B core antigen, or antibody positivity against the hepatitis C virus; --Assessment for active hepatitis B and hepatitis C infection will be repeated for this study even if prior testing during the current pregnancy was negative; * Evidence of Human Immunodeficiency Virus (HIV) infection (e.g., positive HIV serology or detectable viral load); * Positive Group B Streptococcus (GBS) test results by rectovaginal swab performed within 5 weeks of delivery, a prior infant with invasive GBS disease, or GBS bacteriuria at any point during pregnancy; * Evidence of N. gonorrhoeae or C. trachomatis infection by testing performed within 5 weeks of delivery; * History of antibiotic administration during the third trimester of the current pregnancy; * Mothers with serious chronic conditions during pregnancy; * Mothers with complicated pregnancies including pre-eclampsia, chorioamnionitis, placenta previa, vasa previa, placental abruption, or active vaginal bleeding; * Maternal fever on the day of delivery (visit 0); * Infants with complications during delivery, such that the infant requires more than the standard neonatal resuscitation after delivery; * Infants delivered prior to 37 weeks of gestation; * Thick particulate meconium noted upon delivery of the infant; * Presence of a congenital abnormality in the infant for which study participation is not recommended; * Current, diagnosed mental illness or current, diagnosed or self-reported drug or alcohol abuse in the mother that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements; * Use of investigational drugs during the third trimester of pregnancy; or * Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator may: * Pose additional risks from participation in the study, * Interfere with the participant's ability to comply with study requirements, or * May impact the quality or interpretation of the data obtained from the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Mount Sinai West

    New York, New York, 10019, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.