Probiotic and Synbiotic Supplementation for Constipation-related Outcomes in Children With Cerebral Palsy: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in stool consistency (Bristol Stool Scale)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lactobacillus reuteri group
Participants receive Lactobacillus reuteri supplement daily for 28 days.
干预措施: Lactobacillus Reuteri Oral Solution [BioGaia] (Dietary Supplement)
Lactobacillus rhamnosus + Prebiotic (Inulin) group
Participants receive Lactobacillus rhamnosus with prebiotic inulin daily for 28 days.
干预措施: Lactobacillus Rhamnosus (Dietary Supplement)
Lactobacillus rhamnosus + Prebiotic (Inulin) group
Participants receive Lactobacillus rhamnosus with prebiotic inulin daily for 28 days.
干预措施: Prebiotic (inulin) (Dietary Supplement)
Control group
Participants receive standard dietary management (no probiotic supplementation).
结局指标
主要结局
Change in stool consistency (Bristol Stool Scale)
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Aybegum Kalyoncu Aycenk
Assistant Professor
Ordu University