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

Phase 4RecruitingNCT06959758

Ferass Abu Hanna80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Interventions

Probiotic ArmDIETARY_SUPPLEMENT

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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. \*

Outcomes

Primary Outcomes

Constipation Recurrence

Time to recurrence of constipation after PEG withdrawal necessitating retreatment with PEG. This measures how long it takes for constipation to return after stopping laxative treatment, requiring the child to start PEG again.

Time frame: 52 weeks

Secondary Outcomes

Intractable Constipation

Prevalence of intractable constipation after the initial 12 weeks of PEG treatment

Time frame: 12 weeks

Normal Bowel Movements without PEG

Failure to maintain normal bowel movements (defined as \> 3 spontaneous bowel movement per week) with no fecal incontinence (among children older than 4 year old) without necessitating PEG re-treatment, at weeks 24 and 52.