PHGG-LGG Synbiotic in Pediatric Functional Constipation

NCT07580729 | Completed

• 1 other identifier: 2024/197
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

functional constipation; probiotic; synbiotic; LGG; partially hydrolyzed guar gum

Outcome Measures

Primary Outcomes (1)

• Clinical treatment success at Week 12

  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 Outcomes (4)

• Time to First Symptom Improvement

  12 weeks

• Microbiota

  12 weeks

• Time to Second Improvement Milestone

  Baseline to 12 week

• School Absenteeism

  Baseline and Week 12

Study Arms (2)

LGG-PHGG

EXPERIMENTAL

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; Other: Control

Control

ACTIVE COMPARATOR

Dietary and lifestyle counseling only

Other: Control

Interventions

Control OTHER

Dietary and lifestyle counseling only

Control; LGG-PHGG

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

LGG-PHGG

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead
• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: collaborator

Study Sites (1)

University of Health Sciences, Sancaktepe Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: May 12, 2026
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

TU (1)