Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 6 Months to 17

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

PhasePhase 4
Study typeInterventional
Ages6 Months to 17 Years
SexAll
Enrollment80 (estimated)
SponsorHaEmek Medical Center, Israel
Academic / other
Locations1 site (Afula)
StatusRecruiting
StartedAugust 6, 2024
Main results expectedAugust 2027
Study endsAugust 2027
Registry record updatedMay 16, 2025
Trial IDNCT06959758 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.