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

NCT06959758 | Recruiting Phase 4

• 1 other identifier: 0151-23-EMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Constipation

Keywords

constipation; laxatives; PEG 350

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Secondary Outcomes (2)

• Intractable Constipation

  12 weeks

• Normal Bowel Movements without PEG

  52 weeks

Study Arms (2)

BioKid Arm

EXPERIMENTAL

This arm includes children receiving the BioKid LR probiotic supplement alongside standard laxative treatment (PEG 3350), followed by BioKid LR alone after PEG tapering.

Dietary Supplement: Probiotic Arm

Placebo

PLACEBO COMPARATOR

This arm includes children receiving a placebo (maltodextrin powder) alongside standard laxative treatment (PEG 3350), followed by placebo alone after PEG tapering.

Drug: Placebo

Interventions

Probiotic Arm DIETARY_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.

BioKid Arm

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 0.5 - 17 years
• Diagnosis of FC based on Rome IV criteria

You may not qualify if:

• 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
• Prematurity (\<34 weeks)
• S/P intestinal surgery
• Immunodeficiency
• Malignancy
• Children treated with medications associated with constipation. \*

Sponsors & Collaborators

• Ferass Abu Hanna: lead
• Ambrosia - SupHerb Ltd.: collaborator

Study Sites (1)

Emek Medical Center

Afula, Israel

RECRUITING

Related Publications (6)

• Eskesen D, Jespersen L, Michelsen B, Whorwell PJ, Muller-Lissner S, Morberg CM. Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12(R), on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial. Br J Nutr. 2015 Nov 28;114(10):1638-46. doi: 10.1017/S0007114515003347. Epub 2015 Sep 18.

  PMID: 26382580 BACKGROUND

• Banaszkiewicz A, Szajewska H. Ineffectiveness of Lactobacillus GG as an adjunct to lactulose for the treatment of constipation in children: a double-blind, placebo-controlled randomized trial. J Pediatr. 2005 Mar;146(3):364-9. doi: 10.1016/j.jpeds.2004.10.022.

  PMID: 15756221 BACKGROUND

• Modin L, Walsted AM, Rittig CS, Hansen AV, Jakobsen MS. Follow-up in Childhood Functional Constipation: A Randomized, Controlled Clinical Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):594-9. doi: 10.1097/MPG.0000000000000974.

  PMID: 26348685 BACKGROUND

• Bongers ME, van Wijk MP, Reitsma JB, Benninga MA. Long-term prognosis for childhood constipation: clinical outcomes in adulthood. Pediatrics. 2010 Jul;126(1):e156-62. doi: 10.1542/peds.2009-1009. Epub 2010 Jun 7.

  PMID: 20530072 BACKGROUND

• Tabbers MM, DiLorenzo C, Berger MY, Faure C, Langendam MW, Nurko S, Staiano A, Vandenplas Y, Benninga MA; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; North American Society for Pediatric Gastroenterology. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):258-74. doi: 10.1097/MPG.0000000000000266.

  PMID: 24345831 BACKGROUND

• Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.

  PMID: 21382575 BACKGROUND

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ferass Abu Hanna, MD

CONTACT

00972546336583; ferass@Gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 7, 2025
• Study Start: August 6, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-04

Locations

IL (1)