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

Launched by FERASS ABU HANNA · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether a probiotic supplement called BioKid LR® can help children with functional constipation after they stop using a common laxative, PEG 3350. The study is looking for children aged 6 months to 17 years who have been diagnosed with functional constipation. Participants will first take PEG 3350 for 12 weeks and then gradually stop while continuing to take either BioKid LR or a placebo (an inactive powder) for an additional 12 weeks. The aim is to see if taking BioKid LR helps prevent constipation from returning and allows children to have regular bowel movements without needing to restart laxatives.

In total, about 80 children will be involved in the study, and neither the families nor the doctors will know who is receiving the real probiotic or the placebo. Participants will keep a diary to track their bowel habits and attend five visits for check-ups. To be eligible, children must be between 6 months and 17 years old and have a diagnosis of functional constipation, but those with certain medical conditions, like celiac disease or thyroid issues, cannot take part. This study has been approved by an ethics committee and is being conducted following strict guidelines to ensure safety.

Gender

ALL

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. \*