Can a daily powder boost baby gut bacteria and prevent future allergies?

NCT ID NCT06746285

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study tests whether a daily synbiotic supplement—a mix of beneficial bacteria and prebiotics—can safely improve gut health in infants aged 2 to 24 months. 200 babies will receive either the supplement or a placebo for one month. Researchers will check for tummy troubles and changes in gut bacteria to see if the supplement is well-tolerated and shifts the microbiome.

What this could mean

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

Active substance
synbiotic supplement (Bifidobacterium strains and human milk oligosaccharides)
What this could lead to
If successful, this could show that a daily synbiotic helps establish healthy gut bacteria in infants, potentially reducing future allergy or immune issues.
What could go wrong
This is an early-stage trial with only 200 infants, focused on safety and microbiome changes, not on preventing disease. Results may not lead to a proven treatment.

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

110 people

The number who actually took part.

Started

Jan 2025

Finished

Dec 2025

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

2 to 24 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: 1. Evidence of personally signed and dated informed consent document indicating that the caregiver(s) have been informed of all pertinent aspects of the study 2. Caregiver(s) meet the following criteria: 1. 18 Years or Older 2. Legal Guardian of the Infant 3. Intending to cohabitate with the infant/toddler for the duration of the study 4. Can be reached by phone and email for the duration of the study 5. Reads, writes, and speaks English 6. Be able to accurately answer all portions of the questionnaire 7. Have access to a working freezer 8. Intending to be primary caregiver and study responder for duration of study 9. Willing to provide synbiotic either in a bottle or some other format to the infant if on a fully liquid diet 3. The PI considers the Caregiver likely to adequately comply with the study protocol requirements based on demonstrated compliance with initial questionnaires and agreement to complete all diaries 4. The infant or toddler enrolled is: 1. Healthy (has not been diagnosed with any chronic health conditions by a pediatrician) 2. Still using diapers (to facilitate sample collection), and expected to continue in diapers for the duration of the study Exclusion Criteria: 1. Infants/toddlers who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including: * Evidence of major congenital malformations (e.g., cleft palate, extremity malformation) * Any history or suspicion of systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis) * Severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily) * Chronic vomiting (projectile, bilious or bloody emesis) * Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the toddler inappropriate for entry into the study 2. Infants/toddlers who are presently receiving or have received within three months prior to enrollment the following: * Probiotic supplements * Antibiotics * Medication(s) or supplement(s) which are known or suspected to affect the following: i. fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes) ii. stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose) iii. growth (e.g. insulin or growth hormone) iv. gastric acid secretion v. microbiome 3. Infants/toddlers with HIV or hepatitis or lactose sensitivity 4. Infants/toddlers exposed to or displaying symptoms of a disease within 1 month of enrollment, including: * Exposure to COVID-19 * Hematochezia (blood in the stools) * Diarrhea (watery stools that takes the shape of a container \> 5x daily) * Fever (38.2 degrees) * Any other symptom which, in the judgment of the investigator, would make the infant inappropriate for entry into the study 5. Currently participating or having participated in another clinical trial since birth

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As listed by the trial registrant

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Contacts and locations

Locations

  • Persephone Biosciences

    San Diego, California, 92121, United States