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

RecruitingPhase 4Ages 6 Months - 17 YearsAllFerass Abu Hanna
NCT06959758 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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. \*
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What it tests

  • Probiotic Arm
  • Placebo
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Where

1 site
Emek Medical Center
Afula, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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