Probiotics for preventing constipation in children
Official title: Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation: a Double Blind Randomized Control Trial
Run by HaEmek Medical Center, Israel · NCT06959758 · Data updated 2026-11-12
This study is testing whether a probiotic called BioKid LR can help children aged 6 months to 17 years avoid constipation after stopping laxatives.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 6 Months to 17 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | HaEmek Medical Center, Israel Academic / other |
| Locations | 1 site (Afula) |
| Status | Recruiting |
| Started | August 6, 2024 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | May 16, 2025 |
| Trial ID | NCT06959758 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6 months to 17 years diagnosed with functional constipation.
✕Probably not a fit
Patients with chronic diseases or conditions that cause constipation, such as celiac disease or inflammatory bowel disease, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of the probiotic supplement BioKid LR in maintaining normal bowel movements in children aged 6 months to 17 years after discontinuing laxative treatment. Participants will initially take a common laxative, PEG 3350, for 12 weeks, followed by a gradual cessation while continuing with either BioKid LR or a placebo for an additional 12 weeks. The study aims to determine if the probiotic can help prevent the recurrence of constipation without the need for restarting laxatives. Throughout the trial, participants will keep a stool diary to monitor their bowel movements.
Why it matters
Potential benefit: If successful, this could provide a non-pharmacological option for children to maintain regular bowel movements and reduce reliance on laxatives.
How similar studies have gone: Other studies have shown promising results with probiotics in managing gastrointestinal conditions, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 0.5 - 17 years 2. Diagnosis of FC based on Rome IV criteria Exclusion Criteria: 1. Children with chronic diseases which could cause constipation: Celiac disease, food allergy, Hypothyroidism, Inflammatory Bowel Disease, electrolytes disturbances, Cystic fibrosis, Hirschsprung disease, Neuropathic conditions (Spinal cord trauma, Neurofibromatosis, Tethered cord) or intestinal pseudo-obstruction 2. Prematurity (\<34 weeks) 3. S/P intestinal surgery 4. Immunodeficiency 5. Malignancy 6. Children treated with medications associated with constipation. \*
Where it's running
-
Emek Medical Center
Afula, Israel Recruiting
Study contacts
- Study coordinator: Ferass Abu Hanna, MD
- Email: ferass@Gmail.com
- Phone: 00972546336583
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.