Could a probiotic help kids with constipation?
NCT ID NCT07360535
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a probiotic called Bifidobacterium longum can ease constipation in infants and toddlers. 84 children received either the probiotic, a common laxative (lactulose), or both for 28 days. Researchers tracked bowel movements, stool consistency, and gut bacteria changes to see if the probiotic helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bifidobacterium longum subsp. longum probiotic (Dipro-X)
- What this could lead to
- If it works, this could offer a natural, gentle option to help young children with constipation have more regular and comfortable bowel movements.
- What could go wrong
- This is a small, early-phase study (84 children) that was open-label, so results may be biased. The probiotic may not work better than standard treatments like lactulose.
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
-
84 people
The number who actually took part.
- Started
-
Jun 2020
- Finished
-
Feb 2026
- 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
-
0 to 3 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 Hide 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: * According to the diagnostic criteria of Rome IV, the following symptoms include at least 2 and last for at least 1 month: 1. Defecation \<= 2 times per week; 2. have a history of fecal retention; 3. There is a history of pain or difficulty in defecation; 4. There is a history of expelling large pieces of feces; 5. 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; * Term infants, gestational age from 37 to 42 weeks; * Birth weight between 2500 - 4000g; * 0-3 years old; * Parents voluntarily defer major changes in infant feeding practices; * Parents are willing and able to fill in diaries and questionnaires Exclusion Criteria: * Chronic diseases or major medical problems; * Gastrointestinal organic diseases; * Growth retardation; * The mother or child of the breastfeeding child used antibiotics within 4 weeks prior to enrollment; * Infants (in formula and/or supplements) or their mothers used probiotics within 2 weeks before randomization and during the trial; * Has participated in other clinical trials; * Food allergies cause constipation (such as milk, eggs and other foods)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Universiti Sains Malaysia
Pulau Pinang, Malaysia
-
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
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