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

Eskisehir Osmangazi University

Status: Completed

Conditions: Constipation - Functional

Treatments: Other: Control; Dietary Supplement: 4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG

Study type: Interventional

Funder types: Other

Identifiers

NCT07580729

2024/197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

LGG-PHGG

Experimental group

Description:

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

Treatment:

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

Other: Control

Control

Active Comparator group

Description:

Dietary and lifestyle counseling only

Treatment:

Other: Control