Actively Recruiting
Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation
Led by Ferass Abu Hanna · Updated on 2025-05-16
80
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
F
Ferass Abu Hanna
Lead Sponsor
A
Ambrosia - SupHerb Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 0.5 months and 17 years
- Diagnosis of functional constipation based on Rome IV criteria
You will not qualify if you...
- Chronic diseases causing constipation such as celiac disease, food allergy, hypothyroidism, inflammatory bowel disease, electrolyte disturbances, cystic fibrosis, Hirschsprung disease, neuropathic conditions, or intestinal pseudo-obstruction
- Prematurity before 34 weeks of gestation
- History of intestinal surgery
- Immunodeficiency
- Malignancy
- Current treatment with medications known to cause constipation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Emek Medical Center
Afula, Israel
Actively Recruiting
Research Team
F
Ferass Abu Hanna, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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