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OpenTrials
Completed

NCT Number: NCT07580729

PHGG-LGG Synbiotic in Pediatric 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.

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Key information

Conditions

Constipation - Functional

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences, Sancaktepe Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

4.3 g partially hydrolyzed guar gum

1×10⁹ CFU Lacticaseibacillus rhamnosus GG

Once daily, oral, 12 weeks

Plus standardized dietary and lifestyle counseling

Control

Other

Dietary and lifestyle counseling only

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Microbiota

    Time frame: 12 weeks

    Gut microbiota composition changes

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PHGG-LGG-FC

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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