Probiotic and Synbiotic Supplementation for Constipation-related Outcomes in Children With Cerebral Palsy: a Randomized, Double-blind, Placebo-controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ordu University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in stool consistency (Bristol Stool Scale)
Overview
Brief Summary
The goal of this clinical trial is to learn whether using Lactobacillus reuteri or a prebiotic-containing Lactobacillus rhamnosus supplement helps to improve constipation and weight gain in children with cerebral palsy (CP). It will also examine the safety and tolerability of these probiotic products.
The main questions it aims to answer are:
Do these probiotic supplements improve bowel movement frequency and stool consistency?
Do they support better weight gain and nutritional status in children with CP?
Are there any side effects or tolerability issues during treatment?
Researchers will compare Lactobacillus reuteri with prebiotic-enriched Lactobacillus rhamnosus in a randomized, double-blind, controlled design.
Participants will:
Take one of the probiotic products daily for 28 days
Visit the clinic at the beginning and end of the study for measurements and stool testing
Have their caregivers keep a stool diary using the Bristol stool scale
Detailed Description
ClinicalTrials.gov Study Record Example Title The Effect of Using Lactobacillus reuteri and Prebiotic-Containing Lactobacillus rhamnosus Strains on Constipation and Weight Gain in Children with Cerebral Palsy: A Prospective Randomized Controlled Study ________________________________________ Brief Summary This clinical trial aims to determine whether daily supplementation with Lactobacillus reuteri or a prebiotic-enriched Lactobacillus rhamnosus formula can improve constipation and weight gain in children with cerebral palsy (CP). Constipation is a common problem in children with CP due to impaired intestinal motility and disruption of the gut microbiota. The study will compare the effects and safety of two probiotic products over a 28-day period.
________________________________________ Detailed Description Cerebral palsy (CP) is a non-progressive neurodevelopmental disorder characterized by impairments in movement and posture. Gastrointestinal complications, particularly chronic constipation and inadequate weight gain, are frequently observed in this population and may significantly affect quality of life. Altered intestinal motility, limited physical activity, and gut microbiota dysbiosis are considered key contributors to bowel dysfunction in children with CP.
Probiotics have been proposed as a supportive therapeutic approach for gastrointestinal symptoms through modulation of intestinal microbiota, enhancement of barrier function, and regulation of bowel motility. Lactobacillus reuteri and Lactobacillus rhamnosus are among the most commonly studied probiotic strains with documented benefits in pediatric gastrointestinal disorders. The addition of prebiotics such as inulin may further enhance probiotic efficacy by promoting the growth of beneficial bacteria.
This prospective, randomized, double-blind, controlled study is designed to evaluate the effects of daily probiotic supplementation on bowel habits and growth parameters in children with cerebral palsy. Eligible participants are allocated to one of three parallel intervention arms and followed for a 28-day treatment period.
Clinical assessments are conducted at baseline and at the end of the intervention period. Anthropometric measurements are obtained using standardized techniques. Stool samples are collected for laboratory analysis, and stool consistency is evaluated using a validated scoring system. Caregivers maintain a daily stool diary to document bowel movement frequency and gastrointestinal symptoms throughout the study period.
The study evaluates changes in bowel function and growth-related parameters over time, as well as the safety and tolerability of the probiotic formulations. Adverse events and treatment adherence are monitored throughout follow-up. This study aims to provide evidence on whether probiotic supplementation represents a safe and effective supportive strategy for managing constipation and improving nutritional outcomes in children with cerebral palsy.
________________________________________ Study Type Interventional (Clinical Trial) Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double-blind (Participant, Investigator)
- Primary Purpose: Treatment ________________________________________ Estimated Enrollment (Insert total number, e.g., n = 90 participants)
Official Title The Effect of Using Lactobacillus reuteri and Prebiotic-Containing Lactobacillus rhamnosus Strains on Constipation and Weight Gain in Children with Cerebral Palsy: A Prospective Randomized Controlled Study ________________________________________ Arms and Interventions Arm 1: Lactobacillus reuteri Participants receive Lactobacillus reuteri daily for 28 days. Arm 2: Lactobacillus rhamnosus + Prebiotic (Inulin) Participants receive a probiotic containing Lactobacillus rhamnosus with prebiotic inulin daily for 28 days.
Arm 3: Control Group Participants receive standard dietary management for constipation.
________________________________________ Primary Outcome Measures
- Change in defecation frequency [Time Frame: Baseline and Day 28]
- Change in stool consistency (Bristol Stool Scale) [Time Frame: Baseline and Day 28] ________________________________________ Secondary Outcome Measures
- Change in body weight and BMI [Time Frame: Baseline and Day 28]
- Stool pH level [Time Frame: Baseline and Day 28]
- Caregiver-reported gastrointestinal symptoms [Time Frame: Throughout 28-day follow-up]
- Incidence of adverse events [Time Frame: Throughout 28-day follow-up]
________________________________________ Eligibility Criteria
Inclusion Criteria:
- Children aged 2-18 years
- Diagnosed with cerebral palsy (GMFCS levels III-V)
- Chronic constipation meeting Rome IV criteria
- Stable medical condition and able to take oral or enteral feeding
Exclusion Criteria:
• Degenerative neurological diseases
- Congenital gastrointestinal malformations
- Inflammatory bowel disease or metabolic disorders
- Kidney failure
- Antibiotic, probiotic, or prebiotic use within one month before enrollment
- Poor adherence (<95%) or hospitalization during study period ________________________________________ Study Start Date January 2023 Estimated Study Completion Date February 2025 ________________________________________ Location Ordu University Faculty of Medicine, Departments of Pediatric Surgery, Pediatrics, and Pediatric Neurology, Ordu University Training and Research Hospital, Ordu, Turkey
Sponsors and Collaborators
• Sponsor: Ordu University Faculty of Medicine, Department of Pediatric Surgery
• Collaborators: Department of Pediatrics and Division of Pediatric Neurology
• Product Support: Nestlé (Inulin-Enriched Lactobacillus rhamnosus formulation)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Both participants (caregivers and children) and the investigators responsible for data collection and outcome assessment were blinded to group assignments. The probiotic products and packaging were identical in appearance, taste, and labeling. The randomization code was held by an independent coordinator and was not revealed to the study team until data analysis was completed.
Eligibility Criteria
- Ages
- 6 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 6 months and 18 years
- •Clinical diagnosis of cerebral palsy
- •Gross Motor Function Classification System (GMFCS) levels III, IV, or V
- •Chronic constipation diagnosed according to Rome IV criteria
- •Stable medical condition
- •Ability to receive oral or enteral nutrition
Exclusion Criteria
- •Cerebral palsy due to degenerative neurological disorders
- •Constipation due to a known organic cause
- •Congenital gastrointestinal tract malformations
- •Inflammatory bowel disease
- •Metabolic diseases
- •History of kidney failure
- •Use of antibiotics, probiotics, or prebiotics within one month prior to enrollment
- •Anticipated poor adherence to the study protocol
- •Requirement for hospitalization during the study period
Arms & Interventions
Lactobacillus reuteri group
Participants receive Lactobacillus reuteri supplement daily for 28 days.
Intervention: Lactobacillus Reuteri Oral Solution [BioGaia] (Dietary Supplement)
Lactobacillus rhamnosus + Prebiotic (Inulin) group
Participants receive Lactobacillus rhamnosus with prebiotic inulin daily for 28 days.
Intervention: Lactobacillus Rhamnosus (Dietary Supplement)
Lactobacillus rhamnosus + Prebiotic (Inulin) group
Participants receive Lactobacillus rhamnosus with prebiotic inulin daily for 28 days.
Intervention: Prebiotic (inulin) (Dietary Supplement)
Control group
Participants receive standard dietary management (no probiotic supplementation).
Outcomes
Primary Outcomes
Change in stool consistency (Bristol Stool Scale)
Time Frame: Baseline and Day 28
Stool form assessed using the Bristol Stool Scale (types 1-7). Higher scores reflect softer stool consistency.
Change in defecation frequency
Time Frame: Baseline and Day 28
Number of bowel movements per week, recorded in caregiver stool diaries. Increase in defecation frequency indicates improvement in constipation.
Change in Stool Consistency (Bristol Stool Scale)
Time Frame: Baseline and Day 28
Change in stool consistency assessed using the Bristol Stool Scale (types 1-7). Improvement is defined as an increase in Bristol Stool Scale score from baseline to Day 28.
Secondary Outcomes
- Change in stool pH(Baseline and Day 28)
- Change in body weight(Baseline and Day 28)
- Change in body mass index (BMI)(Baseline and Day 28)
- Change in mid-arm circumference(Baseline and Day 28)
- Change in heel-to-knee length(Baseline and Day 28)
- Caregiver-reported gastrointestinal symptoms(Throughout 28-day follow-up)
- Incidence of adverse events(Throughout 28-day follow-up)
Investigators
Aybegum Kalyoncu Aycenk
Assistant Professor
Ordu University