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Probiotics may reshape newborn gut health after C-Section or antibiotics

NCT ID NCT04304014

Disease control Sponsor: Fundacion Clinic per a la Recerca Biomédica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial tests whether giving specific probiotics to healthy newborns can help restore a balanced gut microbiome after a dysbiotic delivery — birth by C-section or after maternal antibiotics. Around 120 infants will receive either L. reuteri or a mix of B. longum and P. pentosaceus daily for one month. Researchers will measure changes in beneficial gut bacteria and track digestive symptoms like spit-ups and constipation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
two different probiotic supplements: L. reuteri or a combination of B. longum and P. pentosaceus
What this could lead to
If successful, this could point toward a simple probiotic strategy to support healthy gut bacteria in babies born by C-section or after maternal antibiotics.
What could go wrong
This is a small, early-stage trial with only 120 infants, and it focuses on gut bacteria levels rather than health outcomes. The benefits may not translate to fewer symptoms or long-term effects.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Mar 2020

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Up to 25 days

Sex

Anyone

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: * Healthy infants up to 25 days of life * Infants with adequate weight according to the gestational age. * Infants born by vaginal delivery whose mother was given antimicrobial prophylaxis or infants born by C-section. * Gestational birth equal or greater than 37 weeks. * Exclusive or almost exclusive breastfeeding (understanding almost exclusive the one in which there is a maximum of one formula feeding per day) or mixed feeding (in which there is more than one formula feeding per day). Exclusion Criteria: * Infants with smoker mother during pregnancy and after delivery. * Infants whose parents cannot follow the study requirements * Infants who have suffered neonatal admission or have suffered or suffer necrotizing enterocolitis, infectious disease, congenital malformation, short bowel syndrome or any serious illness. * Infants who have taken probiotics before the start of the trial or who take formula with probiotics. * Breast-fed infants whose mothers have taken probiotics within the two weeks before study inclusion. * Infants who ingest special formulas as extensively hydrolysed formulas. * Breast-fed infants whose mothers have excluded dairy products and egg products in their diet during breastfeeding * Infants who take specific medication for the treatment of functional digestive disorders: antacids (type IBP or H2 blockers), laxatives (PEG, lactulose, magnesia), lactase and simethicone at the time of inclusion. * Infants undergoing therapies with acupuncture, homeopathy, medicinal herbs, anti-inflammatories and antispasmodics at the time of inclusion.

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Conditions

The condition(s) this trial relates to.

Dysbiosis

As listed by the trial registrant

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

Dysbiosis

Contacts and locations

Locations

  • Fundación HM Hospitales (Hospital HM Puerta Sur)

    Madrid, Madrid, 28938, Spain

  • Hospital Universitari General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195, Spain

  • Neonatal Unit, Hospital Clinic-Maternitat

    Barcelona, Spain

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