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G-PUR® for Symptomatic Treatment in Irritable Bowel Syndrome With Diarrhea

NCT04138186 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-11-13

No results posted yet for this study

Summary

A randomized, double-blind, placebo-controlled pilot study in patients with IBS-D according to Rome IV criteria evaluating the clinical efficacy and safety of oral administration of 2g G-PUR® tid compared to placebo in a cohort of 30 patients over an active treatment period of 12 weeks.

Conditions

  • Irritable Bowel Syndrome With Diarrhea (IBS-D)

Interventions

DEVICE

2.0g G-PUR®, oral administration

tid for 12 weeks

DEVICE

Placebo, oral administration

tid for 12 weeks

Sponsors & Collaborators

  • Glock Health, Science and Research GmbH

    lead INDUSTRY

Principal Investigators

  • Michael Wolzt, Prof. Dr. · Department of Clinical Pharmacology, Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Austria

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 NCT04138186 on ClinicalTrials.gov