What is BioKid LR studying for children with functional constipation?

BioKid LR is being studied to see if it helps children with functional constipation maintain normal bowel movements after stopping laxatives. Researchers want to know if this probiotic can reduce constipation's return and the need for further laxative treatment. The study is led by Ferass Abu Hanna and supported by Supherb Group.

Who may be eligible for this constipation clinical trial?

Children aged 6 months to 17 years diagnosed with functional constipation based on Rome IV criteria may be eligible. The study is open to all genders. Children with certain chronic diseases, premature birth before 34 weeks, intestinal surgery, or those on medications causing constipation cannot join. Please review eligibility criteria for more details.

Is there any cost to participate in this constipation clinical trial?

Study-related care, including the probiotic or placebo and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 4

Age: 6Months - 17Years

All Genders

ID06959758

Study of BioKid LR Probiotic Supplement to Help Maintain Normal Bowel Movements in Children 6 Months to 17 Years With Functional Constipation

Led by Ferass Abu Hanna · Updated on 2025-05-16

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether the probiotic supplement BioKid LR, which contains nine different species of probiotic bacteria including L. Reuteri, can help children aged 6 months to 17 years with functional constipation maintain normal bowel movements after stopping laxative treatment with PEG 3350. The study aims to find out if BioKid LR can reduce the chance of constipation returning and if it can help children avoid restarting laxatives. This trial is a double-blind, randomized controlled study involving 80 children. Participants will first take PEG 3350 along with either the BioKid LR probiotic or a placebo daily for 12 weeks. Then, they will gradually stop the PEG while continuing with either BioKid LR or placebo for another 12 weeks. After this, children will continue only with BioKid LR or placebo for an additional 28 weeks, making the total study duration 52 weeks. The two study groups include one receiving the probiotic supplement and the other receiving an inactive maltodextrin powder as placebo. During the study, participants will keep a stool diary to monitor bowel habits and any side effects. They will attend five study visits for physical exams and monitoring at weeks 0, 12, 24, 38, and 52. Researchers will mainly measure how long it takes for constipation to return after stopping PEG treatment and if retreatment is needed. Secondary outcomes include the number of children needing long-term treatment, regular bowel movements without accidents in children over 4 years old, stool consistency, and frequency. Safety and overall progress will be monitored throughout the year-long study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Months - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 0.5 to 17 years
Diagnosis of functional constipation based on Rome IV criteria

You will not qualify if you...

Children with chronic diseases causing constipation such as celiac disease, food allergy, hypothyroidism, inflammatory bowel disease, electrolyte disturbances, cystic fibrosis, Hirschsprung disease, neuropathic conditions, or intestinal pseudo-obstruction
Premature birth before 34 weeks gestation
History of intestinal surgery
Immunodeficiency
Malignancy
Children treated with medications associated with constipation

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 52 weeks

Participants receive daily doses of either the BioKid LR probiotic supplement or a placebo, alongside standard laxative treatment (PEG 3350) for the first 12 weeks, followed by continued probiotic or placebo alone for the remainder of the 52-week study period.