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
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 1. Change in defecation frequency \[Time Frame: Baseline and Day 28\] 2. Change in stool consistency (Bristol Stool Scale) \[Time Frame: Baseline and Day 28\] \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Secondary Outcome Measures <!-- --> 1. Change in body weight and BMI \[Time Frame: Baseline and Day 28\] 2. Stool pH level \[Time Frame: Baseline and Day 28\] 3. Caregiver-reported gastrointestinal symptoms \[Time Frame: Throughout 28-day follow-up\] 4. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Participants receive \*Lactobacillus reuteri\* supplement once daily for 28 days.
Lactobacillus rhamnosus is administered as part of a single synbiotic product that also contains the prebiotic inulin. The synbiotic formulation is provided as one commercially available product and is administered once daily for 28 days.
Inulin is administered as part of the same single synbiotic product that contains Lactobacillus rhamnosus. The synbiotic formulation is provided as one commercially available product and is administered once daily for 28 days.
Ordu University Faculty of Medicine, Department Of Pediatric Surgery
Ordu, Outside of the US, Turkey (Türkiye)
Change in stool consistency (Bristol Stool Scale)
Stool form assessed using the Bristol Stool Scale (types 1-7). Higher scores reflect softer stool consistency.
Time frame: Baseline and Day 28
Change in defecation frequency
Number of bowel movements per week, recorded in caregiver stool diaries. Increase in defecation frequency indicates improvement in constipation.
Time frame: Baseline and Day 28
Change in Stool Consistency (Bristol Stool Scale)
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.
Time frame: Baseline and Day 28
Change in stool pH
Stool samples analyzed for pH using a standard test kit to evaluate intestinal microbiota activity.
Time frame: Baseline and Day 28
Change in body weight
Change in body weight measured in kilograms. An increase indicates improved nutritional status.
Time frame: Baseline and Day 28
Change in body mass index (BMI)
Change in body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Baseline and Day 28
Change in mid-arm circumference
Change in mid-arm circumference measured in centimeters as an indicator of muscle mass and nutritional status.
Time frame: Baseline and Day 28
Change in heel-to-knee length
Change in heel-to-knee length measured in centimeters as an indicator of linear growth.
Time frame: Baseline and Day 28
Caregiver-reported gastrointestinal symptoms
Caregiver-reported presence and frequency of gastrointestinal symptoms, including gagging, vomiting, retching, bloating, and feeding intolerance, recorded using a daily symptom diary. No composite symptom score is calculated.
Time frame: Throughout 28-day follow-up
Incidence of adverse events
Number and type of any adverse or unexpected reactions observed during the study period.
Time frame: Throughout 28-day follow-up
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