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Gabapral in Pediatric IBS

NCT05737277 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-02-21

No results posted yet for this study

Summary

Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder (FGID) characterized by recurrent episodes of defecation related abdominal pain associated with abnormal bowel habit. Several studies have reported significant alterations in the gut microbiota that may promote the development and persistence of IBS. Some Bifidobacterium species, mainly Bifidobacterium adolescentis, have a documented immunomodulatory effect and can modulate visceral hypersensitivity or improve the integrity of the intestinal epithelium barrier thorough its well-known ability to produce g-aminobutyric acid

Thus, designed a randomised, double-blind, placebo-controlled, parallel-arm study evaluating the efficacy and safety of Bifidobacterium adolescentis PRL2019 on abdominal pain symptoms in pediatric patients with Irritative bowel sindorom

Conditions

  • Bifidobacterium Adolescentis PRL2019
  • IBS
  • Pediatric

Interventions

DRUG

Gabapral

This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to evaluate the efficacy and safety of Bifidobacterium adolescentis PRL2019 in pediatric patients (\> 4 years) with IBS (as assessed according to the Rome IV diagnostic criteria for IBS). The study will include a 2-week screening period, and a 12-week placebo-controlled treatment period (Figure 1). After the screening phase, eligible patients will be randomly assigned to either 1 stick containing 20 Mld UFC of Bifidobacterium adolescentis PRL2019 (Gabapral, Pontenure, Italy), or the equivalent placebo once a day, in a 1:1 ratio, for 12 weeks. Study visits will be conducted every 4 weeks during the treatment period.

DRUG

Placebo

This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to evaluate the efficacy and safety of Bifidobacterium adolescentis PRL2019 in pediatric patients (\> 4 years) with IBS (as assessed according to the Rome IV diagnostic criteria for IBS). The study will include a 2-week screening period, and a 12-week placebo-controlled treatment period (Figure 1). After the screening phase, eligible patients will be randomly assigned to either 1 stick containing 20 Mld UFC of Bifidobacterium adolescentis PRL2019 (Gabapral, Pontenure, Italy), or the equivalent placebo once a day, in a 1:1 ratio, for 12 weeks. Study visits will be conducted every 4 weeks during the treatment period

Sponsors & Collaborators

  • Azienda Ospedaliera "Sant'Andrea"

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-05-01
Completion
2023-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05737277 on ClinicalTrials.gov