Constipation - Functional
Conditions
Keywords
functional constipation, probiotic, synbiotic, LGG, partially hydrolyzed guar gum
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.
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.
Interventions
DIETARY_SUPPLEMENT4.3 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
OTHERControl
Dietary and lifestyle counseling only
Sponsors
Eskisehir Osmangazi University
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical treatment success at Week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to First Symptom Improvement | 12 weeks | Time (in days) from initiation of the intervention to the first reported improvement in constipation-related symptoms |
| Microbiota | 12 weeks | Gut microbiota composition changes |
| Time to Second Improvement Milestone | 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. |
| School Absenteeism | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed