MedTrace Logo

Effect of Probiotics on Constipation and Weight in CP

NCT07393256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-06

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Lactobacillus Reuteri Oral Solution [BioGaia]

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

DIETARY_SUPPLEMENT

Lactobacillus Rhamnosus

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.

DIETARY_SUPPLEMENT

Prebiotic (inulin)

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.

Sponsors & Collaborators

  • Ordu University

    lead OTHER

Principal Investigators

  • Aybegum Kalyoncu Aycenk, Assistant Professor · ORDU UNIVERSITY, FACULTY OF MEDICINE, DEPARTMENT OF PEDIATRIC SURGERY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-03-29
Completion
2025-04-29

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07393256 on ClinicalTrials.gov