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Could a probiotic ease gut troubles in babies with food allergies?

NCT ID NCT05793112

Disease control Sponsor: Massachusetts General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a probiotic called INF108F in 20 breastfed infants with a food allergy that causes blood in their stool. The goal was to see if the probiotic could improve the balance of gut bacteria and reduce symptoms like reflux and fussiness. While the treatment aims to control the condition, it is not a cure and ongoing management may still be needed.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

20 people

The number who actually took part.

Started

Sep 2023

Finished

Sep 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

1 day to 90 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Infants, male or female, of all ethnic/racial groups, with a gestational period of 37 to 42 weeks * Infants aged 1 - 90 days old with a documented FPIAP with either gross blood or microscopic blood in without other possible causes * Infants must be exclusively breastfed or at least half of oral intake is from breast feeding or from expressed breast milk * A willing parent or legal guardian will sign the consent form either electronically or with a wet ink signature Exclusion Criteria: * Infants born earlier than 37 weeks of gestation * Infants who are exclusively formula-fed or less than half of oral intake is from breastfeeding or from expressed breast milk at the time of enrollment * Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies) * Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions, gastrointestinal inflammatory conditions, or renal insufficiency * History of abdominal surgery or congenital abnormalities of the GI track, the cardiovascular system, the pulmonary system or the renal system * Antibiotic use (oral or systemic) within 7 days prior to enrollment * Mother's intent to feed non-study probiotics or solid food to their infant at any time during the study * Mothers with substance use disorder (SUD) or on Nicotine replacement therapy (NRT) * Infants who have consumed any B. infantis-containing probiotics since birth

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Conditions

The condition(s) this trial relates to.

food protein-induced allergic proctocolitis

As listed by the trial registrant

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

Food protein induced allergic proctocolitis Gut microbiome Infant development

Contacts and locations

Locations

  • Newton Wellesley Hospital

    Newton, Massachusetts, 02462, United States

More trials for these conditions

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