Effect of Probiotics on Constipation and Weight in CP

NCT07393256 | Completed

• 1 other identifier: 2023/82
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Palsy (CP); Constipation; Probiotic

Keywords

cerebral palsy; constipation; children; probiotics; Lactobacillus reuteri; Lactobacillus rhamnosus; inulin

Outcome Measures

Primary Outcomes (3)

• Change in stool consistency (Bristol Stool Scale)

  Stool form assessed using the Bristol Stool Scale (types 1-7). Higher scores reflect softer stool consistency.

  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.

  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.

  Baseline and Day 28

Secondary Outcomes (7)

• 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

Study Arms (3)

Lactobacillus reuteri group

EXPERIMENTAL

Participants receive Lactobacillus reuteri supplement daily for 28 days.

Dietary Supplement: Lactobacillus Reuteri Oral Solution [BioGaia]

Lactobacillus rhamnosus + Prebiotic (Inulin) group

EXPERIMENTAL

Participants receive Lactobacillus rhamnosus with prebiotic inulin daily for 28 days.

Dietary Supplement: Lactobacillus Rhamnosus; Dietary Supplement: Prebiotic (inulin)

Control group

NO INTERVENTION

Participants receive standard dietary management (no probiotic supplementation).

Interventions

Lactobacillus Rhamnosus DIETARY_SUPPLEMENT

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.

Lactobacillus rhamnosus + Prebiotic (Inulin) group

Prebiotic (inulin) DIETARY_SUPPLEMENT

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.

Lactobacillus rhamnosus + Prebiotic (Inulin) group

Lactobacillus Reuteri Oral Solution [BioGaia] DIETARY_SUPPLEMENT

Participants receive \*Lactobacillus reuteri\* supplement once daily for 28 days.

Lactobacillus reuteri group

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University Faculty of Medicine, Department Of Pediatric Surgery

Ordu, Outside of the US, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Constipation

Interventions

Prebiotics; Inulin

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Fructans

Study Officials

• Aybegum Kalyoncu Aycenk, Assistant Professor

  ORDU UNIVERSITY, FACULTY OF MEDICINE, DEPARTMENT OF PEDIATRIC SURGERY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is designed as a prospective, double-blind, randomized controlled trial with three parallel groups. Participants with cerebral palsy and chronic constipation are randomly assigned in equal numbers to one of three groups: (1) Lactobacillus reuteri, (2) Lactobacillus rhamnosus supplemented with prebiotic inulin, or (3) control. Each participant receives only one intervention throughout the 28-day study period. Neither the participants, caregivers, nor the investigators responsible for assessment are aware of group allocation.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 6, 2026
• Study Start: November 1, 2022
• Primary Completion: March 29, 2025
• Study Completion: April 29, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)