Gabapral in Pediatric IBS

NCT05737277 | Unknown DMC

• 1 other identifier: GAB-IBSPED
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rome IV criteria

  The primary outcome will be the improve in the abdominal pain symptoms (frequency and severity) according to validated score from baseline to the end of the treatment period.

  2 months

Secondary Outcomes (1)

• bristol stool scale

  6 months

Study Arms (2)

GABAPRAL

EXPERIMENTAL

Children with irritative bowel sindrome who received 20 Mld UFC of Bifidobacterium adolescentis PRL 2019 once a day for 12 weeks

Drug: Gabapral

Placebo

PLACEBO COMPARATOR

Children with irritative bowel sindrome who received placebo once a day for 12 weeks

Drug: Placebo

Interventions

Gabapral DRUG

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.

GABAPRAL

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• IBS subtypes 4 -17 years of age,
• negative fecal calprotectine
• negative anti-transglutaminasi antibodies.

You may not qualify if:

• the current use of nonsteroidal anti-inflammatory drugs, corticosteroids and mast cell stabilisers,
• the use of topical or systemic antibiotics in the last month,
• use of stimulant laxatives,
• major abdominal surgery,
• inflammatory bowel disease,
• infectious diarrhoea,
• allergic diseases a
• psychiatric disorders.

Sponsors & Collaborators

• Azienda Ospedaliera "Sant'Andrea": lead

Central Study Contacts

Giovanni Di Nardo, Prof

CONTACT

00393397267637; giovanni.dinardo@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 21, 2023
• Study Start: March 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02