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Can probiotic drops soothe baby tummies and skin?

NCT ID NCT07444008

Symptom relief Sponsor: NovoNatum Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a daily probiotic supplement called BioAmicus Complete can help infants with colic, constipation, diarrhea, and eczema. 140 babies will receive either the probiotic drops or a placebo (sunflower oil) for 25 days. Researchers will track changes in stool, crying, reflux, and skin symptoms to see if the supplement provides relief.

What this could mean

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

Active substance
BioAmicus Complete (a mixture of 10 strains of lacto- and bifidobacteria)
What this could lead to
If it works, this could offer a simple, natural option to help babies with common tummy troubles and skin symptoms linked to food allergies.
What could go wrong
This is a small, early-stage study with no phase designation, so results are uncertain. The supplement may work no better than placebo, and individual babies may not respond.

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 140 people

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

Started

Mar 2026

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

1 month to 5 months

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: * The child's parents/guardians speak Russian, have been informed about the study's purpose, understand its essence, are aware of their rights, and have signed the informed consent form. * Diarrhea or constipation accompanied by colic and/or regurgitation (gastroesophageal reflux, GER). * Cutaneous manifestations of food allergy. * The child was born at term or preterm, but not before the 7th month of gestation. * Age at the time of parental informed consent: from 1 month to 4 months and 28 days. * The child is on breastfeeding, formula feeding, or mixed feeding. * The child has no other health conditions that would require a specialized diet. * The parents/guardians are able and willing to regularly complete the proposed observation diary form. Exclusion Criteria: * The child has a congenital pathology or any other conditions/diseases/clinical manifestations that may interfere with participation in the study. * Use of lactase supplements. * Use of other probiotic products, antibiotics, enteral antiseptics, antifungal, or antiprotozoal medications. * The child was born preterm (before the 7th month of gestation).

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Conditions

The condition(s) this trial relates to.

atopic eczema constipation disorder diarrheal disease gastroesophageal reflux disease infantile diarrhea

As listed by the trial registrant

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

Atopic dermatitis Constipation Infantile colics Infantile diarrhea

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

  • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 43"

    RECRUITING

    Saint Petersburg, 198207, Russia

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