PHGG-LGG Synbiotic in Pediatric Functional Constipation (PHGG-LGG-FC)

May 5, 2026 updated by: Ener Cagri DINLEYICI, Eskisehir Osmangazi University

Effects of a Partially Hydrolyzed Guar Gum and Lacticaseibacillus Rhamnosus GG Combination on Clinical Outcomes and Microbiota in Children With Functional Constipation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Functional constipation is common in children and has been associated with gut microbiota dysbiosis and impaired short-chain fatty acid production. Synbiotics combining prebiotics and probiotics may improve stool characteristics and intestinal fermentation.

This study investigated whether daily supplementation with PHGG (4.3 g) plus LGG (1×10⁹ CFU) for 12 weeks improves stool frequency, consistency, gastrointestinal symptoms, and microbiota composition compared with standard dietary advice alone. Whole-genome shotgun metagenomics was performed in a subset of participants to characterize microbial and functional changes.

This study was registered retrospectively on ClinicalTrials.gov because it was initiated as an investigator-initiated academic study without initial intent for regulatory submission. Registration was completed after study completion to ensure transparency and compliance with journal and international reporting standards.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34000
        • University of Health Sciences, Sancaktepe Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥4 years
  • Diagnosis of functional constipation per Rome IV
  • Parental informed consent

Exclusion Criteria:

  • Organic causes of constipation
  • Chronic medication use
  • Antibiotics or biotics within 8 weeks
  • Age <4 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LGG-PHGG

PHGG + LGG Synbiotic

4.3 g partially hydrolyzed guar gum

1×10⁹ CFU Lacticaseibacillus rhamnosus GG

Once daily, oral, 12 weeks

Plus standardized dietary and lifestyle counseling
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
Active Comparator: Control
Dietary and lifestyle counseling only
Other: Control
Dietary and lifestyle counseling only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical treatment success at Week 12
Time Frame: 12 weeks

Clinical treatment success at Week 12, defined as:

≥3 spontaneous bowel movements per week AND

Bristol Stool Scale type 3-4 AND

No longer fulfilling Rome IV criteria
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Symptom Improvement
Time Frame: 12 weeks
Time (in days) from initiation of the intervention to the first reported improvement in constipation-related symptoms
12 weeks
Microbiota
Time Frame: 12 weeks
Gut microbiota composition changes
12 weeks
Time to Second Improvement Milestone
Time Frame: Baseline to 12 week
Time (in days) from initiation of the intervention to the second clinically meaningful improvement milestone, defined as sustained improvement in bowel movement frequency and/or stool consistency accompanied by reduction in associated gastrointestinal symptoms, as documented in daily follow-up records.
Baseline to 12 week
School Absenteeism
Time Frame: Baseline and Week 12
Number of school days missed and presence of school absenteeism due to constipation-related symptoms, as reported by parents during the study period.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024/197

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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