CompletedNot Applicable

Effect of Probiotics on Constipation and Weight in CP

Turkey (Türkiye)30 participantsStarted 2022-11-01

Plain-language summary

The goal of this clinical trial is to learn whether using Lactobacillus reuteri or a prebiotic-containing Lactobacillus rhamnosus supplement helps to improve constipation and weight gain in children with cerebral palsy (CP). It will also examine the safety and tolerability of these probiotic products. The main questions it aims to answer are: Do these probiotic supplements improve bowel movement frequency and stool consistency? Do they support better weight gain and nutritional status in children with CP? Are there any side effects or tolerability issues during treatment? Researchers will compare Lactobacillus reuteri with prebiotic-enriched Lactobacillus rhamnosus in a randomized, double-blind, controlled design. Participants will: Take one of the probiotic products daily for 28 days Visit the clinic at the beginning and end of the study for measurements and stool testing Have their caregivers keep a stool diary using the Bristol stool scale

Who can participate

Age range

6 Months – 18 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: * Age between 6 months and 18 years * Clinical diagnosis of cerebral palsy * Gross Motor Function Classification System (GMFCS) levels III, IV, or V * Chronic constipation diagnosed according to Rome IV criteria * Stable medical condition * Ability to receive oral or enteral nutrition Exclusion Criteria: * Cerebral palsy due to degenerative neurological disorders * Constipation due to a known organic cause * Congenital gastrointestinal tract malformations * Inflammatory bowel disease * Metabolic diseases * History of kidney failure * Use of antibiotics, probiotics, or prebiotics within one month prior to enrollment * Anticipated poor adherence to the study protocol * Requirement for hospitalization during the study period

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

Change in stool consistency (Bristol Stool Scale)

Timeframe: Baseline and Day 28

Change in defecation frequency

Timeframe: Baseline and Day 28

Change in Stool Consistency (Bristol Stool Scale)

Timeframe: Baseline and Day 28

Trial details

NCT IDNCT07393256

SponsorOrdu University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-29

View on ClinicalTrials.gov More Cerebral Palsy (CP) trials

Plain-language summary

Who can participate

Age range

6 Months – 18 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.