CompletedPhase 2

Effect of Probiotic on Gut Microbiota in Young Children With Functional Constipation

China, Malaysia84 participantsStarted 2020-06-10

Plain-language summary

This study was a 28-day, open-label, randomized controlled trial involving infants and toddlers diagnosed with functional constipation. Participants were randomized to receive either Bifidobacterium longum subsp. longum Dipro-X, lactulose, or a combination of both. The primary clinical outcomes assessed were bowel movement frequency, stool consistency, and defecation difficulty. To investigate potential mechanisms, stool samples were collected pre- and post-intervention for metagenomics sequencing to analyze changes in gut microbiota composition and identify specific bacterial taxa associated with clinical improvements.

Who can participate

Age range

0 Years – 3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Defecation \<= 2 times per week;
. have a history of fecal retention;
. There is a history of pain or difficulty in defecation;
. There is a history of expelling large pieces of feces;
. There is a large fecal mass in the rectum. At least 1 episode of incontinence per week after self-control of bowel movements; passing large pieces of stool that may clog the toilet;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Defecation difficulty in young children upon administration of probiotic, lactulose or their combinations as assessed via Visual Anologue Scale (VAS)

Timeframe: Day-0, day-14, day-28

Bowel movement frequency in young children upon administration of probiotic, lactulose or their combinations as assessed via patients' diary

Timeframe: Day-0, day-28

Bristol stool score in young children upon administration of probiotic, lactulose or their combinations as assessed via Bristol stool chart

Timeframe: Day-0, day-14, day-28

Trial details

NCT IDNCT07360535

SponsorMin-Tze LIONG

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-28

View on ClinicalTrials.gov More Functional Constipation in Children trials

Plain-language summary

Who can participate

Age range

0 Years – 3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Defecation \<= 2 times per week;
. have a history of fecal retention;
. There is a history of pain or difficulty in defecation;
. There is a history of expelling large pieces of feces;
. There is a large fecal mass in the rectum. At least 1 episode of incontinence per week after self-control of bowel movements; passing large pieces of stool that may clog the toilet;

What they're measuring

Defecation difficulty in young children upon administration of probiotic, lactulose or their combinations as assessed via Visual Anologue Scale (VAS)

Timeframe: Day-0, day-14, day-28

Bowel movement frequency in young children upon administration of probiotic, lactulose or their combinations as assessed via patients' diary

Timeframe: Day-0, day-28

Bristol stool score in young children upon administration of probiotic, lactulose or their combinations as assessed via Bristol stool chart

Timeframe: Day-0, day-14, day-28