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Effect of 35624® Alflorex® in Functional Gastrointestinal Disorders (FGIDs) in Children.

NCT04922476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-09-08

No results posted yet for this study

Summary

The aim of this study is to evaluate the effect of supplementation with Bifidobacterium longum 35624® Alflorex® on frequency and severity of symptoms of abdominal pain using an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS) to accurately reflect the pediatric population using the aid of the validated Numeric Pain Rating Scale (NRS-II) in children with Functional Gastrointestinal Disorders (FGIDs).

Conditions

  • Functional Gastrointestinal Disorders
  • Functional Abdominal Pain

Interventions

DIETARY_SUPPLEMENT

Alflorex®

Each probiotic capsule contains 1 x 10\^9 CFU of B. longum 35624® and corn starch, hydroxypropyl methyl cellulose and magnesium stearate.

Sponsors & Collaborators

  • Instituto de Nutrición y Tecnología de los Alimentos

    collaborator OTHER

  • PrecisionBiotics Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Eileen Murphy, PhD · PrecisionBiotics Group Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2023-03-04
Completion
2023-04-04

Countries

  • Chile

Study Locations

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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 NCT04922476 on ClinicalTrials.gov