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

Official title

Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation: a Double Blind Randomized Control Trial

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.

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.

Primary outcome measures

• Constipation Recurrence [Time frame: 52 weeks]

Secondary outcome measures (2)

• Intractable Constipation [Time frame: 12 weeks]
• Normal Bowel Movements without PEG [Time frame: 52 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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. \*

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Triple blind

Primary purpose

Treatment

Study locations

Israel · 1 center

• Emek Medical Center — Afula

Publications

• 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/S000711451500334 PMID 26382580
• 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
• 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
• 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
• 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 PMID 24345831
• 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

Identifiers

NCT: NCT06959758 · 0151-23-EMC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗