Clinical Trial to Evaluate the Effect of a Probiotic Mixture on Signs and Symptoms of Irritable Bowel Syndrome

NCT05565612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-03-28

No results posted yet for this study

Summary

The clinical trial has a randomized, double-blind and placebo-controlled design, in which the effect of a probiotic mix wants to be evaluated, with a treatment of 12 weeks, in the evolution of the symptoms of Irritable Bowel Syndrome.

The 12 weeks of the treatment are structured in four in-person visits: Visit 1 (initial; week 0), Visit 2 (halfway; week 4), Visit 3 (halfway; week 8) and Visit 4 (final; week 12).

Conditions

  • IBS - Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

Normodigest Classic

Symbiotic composed of 15 probiotic strains and fructooligosaccharides as prebiotic

DIETARY_SUPPLEMENT

Placebo

Compound based on maltodextrin and other excipients

Sponsors & Collaborators

  • Laboratorio Industrial de Herbodietetica Aplicada S.L

    lead INDUSTRY

Principal Investigators

  • Vicente Navarro López, PhD; MD · Universidad Católica San Antonio de Murcia (UCAM). MiBioPath Group.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2023-12-26
Completion
2024-03-01

Countries

  • Spain

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 NCT05565612 on ClinicalTrials.gov