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L. Reuteri DSM 17938 and L. Reuteri ATCC PTA 6475 in Moderate to Severe Irritable Bowel in Adults

NCT04037826 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-06-27

No results posted yet for this study

Summary

Randomized, double blind, controlled clinical trial, to evaluate safety and efficacy of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475 as adjuvant to reduce the severity of symptoms in adults with moderate to severe irritable bowel syndrome (IBS). Primary outcome: Global clinical Improve assessed by the GSRS-IBS score. Adults 18-65 years, any gender, with ROME IV criteria for moderate to severe IBS and body max index \<36 will be included. Prescreening will be run for 2 weeks, the intervention period will be 2/days for 14t weeks, follow by a 2 weeks period of observation with no intervention. Secondary outcomes include: a) Improvements in the stool patterns evaluated through Bristol Stool Form (BSF); b) Improvement of the quality of life (QoL) measured by Latin-American IBS-QoL questionnaire; c) Improvement of the depression and anxiety severity evaluated by the Goldberg Depression and Anxiety Scale; d) Frequency of rescue medication use and e) Frequency of Adverse Events (AEs)

Conditions

  • Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475

L. reuteri Gastrus (L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475) at dose of 2x108 Colony Forming Units (CFU) per tablet. One chewable tablet is to be taken twice per day (one in the morning and one in the afternoon) giving a total daily dose of at least 4x108 CFU/day.

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • Innovacion y Desarrollo de Estrategias en Salud

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2019-09-30
Completion
2022-12-30

Countries

  • Chile
  • Mexico

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 NCT04037826 on ClinicalTrials.gov