PHGG-LGG Synbiotic in Pediatric Functional Constipation (PHGG-LGG-FC)
Effects of a Partially Hydrolyzed Guar Gum and Lacticaseibacillus Rhamnosus GG Combination on Clinical Outcomes and Microbiota in Children With Functional Constipation
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Istanbul, Tyrkiet (Türkiye), 34000
- University of Health Sciences, Sancaktepe Training and Research Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
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 and lifestyle counseling only
|
|
Aktiv komparator: Control
Dietary and lifestyle counseling only
|
Dietary and lifestyle counseling only
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical treatment success at Week 12
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to First Symptom Improvement
Tidsramme: 12 weeks
|
Time (in days) from initiation of the intervention to the first reported improvement in constipation-related symptoms
|
12 weeks
|
|
Microbiota
Tidsramme: 12 weeks
|
Gut microbiota composition changes
|
12 weeks
|
|
Time to Second Improvement Milestone
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2024/197
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .