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Could a daily probiotic soothe both bellyaches and anxiety in children?

NCT ID NCT02711800

Symptom relief Sponsor: Nancy Zucker 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 small pilot study tested whether a daily probiotic (Lactobacillus rhamnosus) could reduce abdominal pain and anxiety in children aged 9 to 13. Nine children who had both anxiety and stomach pain took the probiotic for 30 days. Researchers measured changes in pain and anxiety before and after treatment. Because the study was very small and had no placebo group, the results are preliminary and meant to guide future, larger studies.

What this could mean

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

Active substance
Lactobacillus rhamnosus (Culturelle Kids probiotic)
What this could lead to
If it works, this could point toward a simple probiotic treatment for children with both anxiety and stomach pain.
What could go wrong
This is a very small pilot study with only 9 participants, so results may not apply to other children. The trial is also open-label, meaning no placebo was used, which can bias outcomes.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

9 people

The number who actually took part.

Started

Nov 2016

Finished

Sep 2017

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

9 to 13 years

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: Participants need to meet the criteria for functional abdominal pain as specified by the Rome III: Scenario #1 Criteria for inclusion 1. In the last 2 months, how often did the child have pain or an uncomfortable feeling in the upper abdomen above the belly button? If ≥ 8 (or if the combination of #1 and #2 is ≥8) 2. In the last 2 months, how often did the child have pain or an uncomfortable feeling in the upper abdomen below the belly button? If ≥ 8 (or if the combination of #1 and #2 is ≥8) Scenario #2 Criteria for inclusion 3. In the last 2 months, when the child hurt or felt uncomfortable above (below) the belly button, how often did your child miss school or stop activities? If #1 and #2 is ≥ 2 (or if the combination of #1 and #2 is ≥2) and #3 is ≥ 25% of the time. They also have to be at or above cutoff (i.e. TS\>= 55) for Beck Youth Inventory (BYI) which can be determined by finding the corresponding raw score, gender, and age on Appendix A in the BYI manual. Exclusion Criteria: 1\. Participants with immune disorders will be automatically excluded from this study.

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Conditions

The condition(s) this trial relates to.

Abdominal Pain anxiety anxiety disorder

As listed by the trial registrant

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

Abdominal pain Anxiety

Contacts and locations

Locations

  • Duke Center for Developmental Epedimiology

    Durham, North Carolina, 27701, United States

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