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Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation

NCT06959758 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-16

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether a probiotic supplement, BioKid LR®, can help maintain normal bowel movements after stopping laxative treatment (PEG 3350) in children aged 6 months to 17 years with functional constipation.

The main questions it aims to answer are:

Does taking BioKid LR reduce the chance of constipation coming back after stopping PEG? Can BioKid LR help children maintain regular bowel movements without needing to restart laxatives? Researchers will compare children who take BioKid LR with those who take a placebo (an inactive powder) to see if the probiotic helps prevent constipation from returning.

Participants will:

Take PEG 3350 (a common laxative) for 12 weeks along with either BioKid LR or a placebo.

After 12 weeks, begin gradually stopping PEG while continuing with BioKid LR or placebo for another 12 weeks.

Then continue only with BioKid LR or placebo for an additional 28 weeks (total study duration: 52 weeks).

Keep a stool diary to track bowel habits and any side effects. Attend 5 study visits for physical exams and monitoring (weeks 0, 12, 24, 38, 52).

The study includes 80 children and is double-blinded, meaning neither the doctors nor the participants know who is receiving the real probiotic or the placebo.

The primary outcome is how long it takes for constipation to return after stopping PEG, requiring retreatment.

Secondary outcomes include:

How many children still need long-term treatment. How many have regular bowel movements without accidents (in children over 4 years old).

Stool consistency and frequency. Children with certain medical conditions (like celiac disease or hypothyroidism) or who are taking medications that cause constipation cannot participate.

This study is supported by Supherb Group, Israel, but they are not involved in designing or analyzing the research. The study has been approved by an ethics committee and follows international ethical guidelines.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic Arm

It is administered daily to children with functional constipation, alongside standard laxative treatment (PEG 3350) for the first 12 weeks, and then continued alone for the remainder of the 52-week study period. The study evaluates whether BioKid LR® helps maintain normal bowel movements after stopping PEG.

DRUG

Placebo

A placebo maltodextrin powder is administered daily to children with functional constipation, alongside standard laxative treatment (PEG 3350) for the first 12 weeks, and then continued alone for the remainder of the 52-week study period.

Sponsors & Collaborators

  • Ambrosia - SupHerb Ltd.

    collaborator INDUSTRY

  • Ferass Abu Hanna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-06
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06959758 on ClinicalTrials.gov