Probiotics for preventing constipation in children

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

This study is testing whether a probiotic called BioKid LR can help children aged 6 months to 17 years avoid constipation after stopping laxatives.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 6 Months to 17 Years
• Sex: All
• Sponsor: HaEmek Medical Center, Israel (other)
• Locations: 1 site (Afula)
• Trial ID: NCT06959758 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the probiotic supplement BioKid LR in maintaining normal bowel movements in children aged 6 months to 17 years after discontinuing laxative treatment. Participants will initially take a common laxative, PEG 3350, for 12 weeks, followed by a gradual cessation while continuing with either BioKid LR or a placebo for an additional 12 weeks. The study aims to determine if the probiotic can help prevent the recurrence of constipation without the need for restarting laxatives. Throughout the trial, participants will keep a stool diary to monitor their bowel movements.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 months to 17 years diagnosed with functional constipation.

Not a fit: Patients with chronic diseases or conditions that cause constipation, such as celiac disease or inflammatory bowel disease, may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a non-pharmacological option for children to maintain regular bowel movements and reduce reliance on laxatives.

How similar studies have performed: Other studies have shown promising results with probiotics in managing gastrointestinal conditions, suggesting potential success for this approach.

Eligibility criteria

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. \*

Where this trial is running

Afula

• Emek Medical Center — Afula, Israel (RECRUITING)

Study contacts

• Study coordinator: Ferass Abu Hanna, MD

Conditions: Constipation, constipation, laxatives, PEG 350