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Can a daily probiotic soothe colicky babies and calm eczema?

NCT ID NCT07754968

Symptom relief Sponsor: University of Roma La Sapienza Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether giving formula-fed infants under 5 months a daily probiotic (Bifidobacterium bifidum) can reduce crying time by at least half in babies with colic, and also improve eczema symptoms. Over 8 weeks, half the babies receive the probiotic drops and half receive a placebo. Parents track crying, sleep, and bowel habits, and provide stool samples to see how the probiotic affects gut bacteria.

What this could mean

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

Active substance
Bifidobacterium bifidum probiotic drops (Bifipral®)
What this could lead to
If effective, this probiotic could offer a safe, simple way to reduce crying in colicky infants and possibly improve eczema symptoms.
What could go wrong
The trial is small and early, and results may not apply to all babies. Probiotics can cause mild digestive upset, and the effect on eczema is uncertain.

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

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

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 week to 5 months

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: * Non-breastfed infants aged ≤ 5 months diagnosed with infant colic according to Rome IV criteria, with or without atopic dermatitis. * Written informed consent from parents or legal guardians. Exclusion Criteria: * Age \> 5 months. * Exclusive breastfeeding or mixed feeding. * Absence of infant colic diagnosis. * Presence of chronic diseases, neoplasms, immunodeficiencies, chronic infections, autoimmune diseases, IBD, celiac disease, genetic-metabolic disorders, cystic fibrosis or other chronic pulmonary diseases, cardiovascular/respiratory/GI malformations, neuropsychiatric disorders, neurological conditions, or vegetarian/vegan diet.

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Conditions

The condition(s) this trial relates to.

atopic eczema Colic

As listed by the trial registrant

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

Atopic dermatitis Infant colic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Sant'Andrea

    RECRUITING

    Roma, RM, 00189, Italy

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