MedTrace Logo

PHGG-LGG Synbiotic in Pediatric Functional Constipation

NCT07580729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-05-12

No results posted yet for this study

Summary

This prospective, randomized controlled open-label trial evaluated the efficacy of a synbiotic consisting of partially hydrolyzed guar gum (PHGG) and Lacticaseibacillus rhamnosus GG (LGG) on clinical outcomes and gut microbiota in children with functional constipation. Children aged 4-16 years meeting Rome IV criteria were randomized to receive either synbiotic supplementation plus dietary counseling or dietary counseling alone for 12 weeks. Clinical outcomes, gastrointestinal symptoms, and stool microbiota (shotgun metagenomics) were assessed at baseline and at week 12.

Conditions

  • Constipation - Functional

Interventions

DIETARY_SUPPLEMENT

4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG

4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG Once daily, oral, 12 weeks Plus standardized dietary and lifestyle counseling

OTHER

Control

Dietary and lifestyle counseling only

Sponsors & Collaborators

  • Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

    collaborator OTHER

  • Eskisehir Osmangazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2024-12-01
Completion
2024-12-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT07580729 on ClinicalTrials.gov