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

NCT04138186 | Unknown

• 1 other identifier: G-IBS_01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

IBS; Diarrhea; Gastrointestinal function disorder

Outcome Measures

Primary Outcomes (1)

• The rate of responders for the patient's global assessment of relief using the last four assessments in the treatment period.

  12 weeks

Secondary Outcomes (24)

• Patient's global assessment of symptom relief measured on a 5-point Likert scale (1= very good and 5= very poor)

  12 weeks

• Incidence of adverse (and serious) events

  12 weeks

• Daily intensity of bloating using a 11-point numerical rating scale (NRS) where 0 represents no bloating discomfort and 10 represents very severe bloating discomfort

  12 weeks

• Daily urgency using a 11-point numerical rating scale (NRS) where 0 represents no defecation urgency and 10 represents worst imaginable urgency

  12 weeks

• Daily stool frequency

  12 weeks

Study Arms (2)

2.0g G-PUR® capsules

EXPERIMENTAL

Device: 2.0g G-PUR®, oral administration

Placebo capsules

PLACEBO COMPARATOR

Device: Placebo, oral administration

Interventions

2.0g G-PUR®, oral administration DEVICE

tid for 12 weeks

2.0g G-PUR® capsules

Placebo, oral administration DEVICE

tid for 12 weeks

Placebo capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Recurrent abdominal pain, at least one day/week in the last 3 months (with symptom onset at least 6 months before diagnosis), associated with two or more of the following criteria (Rome IV criteria)
• Related to defecation
• Associated with a change in frequency of stool
• Associated with a change in form (appearance) of stool.
• Moderate to severe abdominal pain as defined with an IBS Symptoms Severity Scale (IBS-SSS) score \> 175
• Patient reports that abnormal bowel movements are usually diarrhea with more than one-fourth (25%) of bowel movements with Bristol stool form types 6 or 7 and less than one-fourth (25%) of bowel movements with Bristol stool form types 1 or 2. Starting during the screening/run-in phase, all patients will keep diaries of stool frequency and consistency. Stool consistency will be assessed according to the Bristol Stool Form scale (Lewis and Heaton, 1997)
• Stable eating habits, within one month before randomization
• In patients \> 50 years colonoscopy performed during the past 5 years demonstrates no pathology associated with the symptoms reported for IBS
• Ability to understand trial instructions and to comply with treatment
• Patient agree to be compliant for study interactive web - response system schedule confirmed at time of randomization
• Written informed consent prior to enrolment

You may not qualify if:

• Patient has exclusively constipation-predominant IBS (IBS-C) that is characterized by \< 3 bowel movements/week or hard and lumpy stools (e.g. Bristol stool form types 1 or 2)
• Patient has irritable bowel syndrome with mixed bowel habits (IBS-M) with varying symptoms of constipation and diarrhea
• Calprotectin stool value \> 200mg/kg stool
• Known hypersensitivity to the IMD (known aluminium and/or silicon hypersensitivity)
• Patient has failed to record \>50% of daily diary entries during run-in period
• Rectal bleeding in the absence of documented bleeding hemorrhoids or anal fissures assessed by fecal occult blood test
• History of major gastric, hepatic, pancreatic or intestinal surgery or perforation with exception of appendectomy, cholecystectomy and inguinal hernia
• Patients with a history of positive tests for ova, parasites or clostridium difficile must undergo repeat testing, which must be negative, during the screening period
• Use of the following prohibited medications: any antibiotics including rifaximin within the past 2 months or during treatment period, use of cholestyramine during entire study period, during run-in phase and during the treatment period any use of concomitant medication effecting the gastrointestinal movement and/or function (e.g. anticholinergic drugs, 5-HT3 receptor antagonists, prokinetic agents, intestinal flora regulating drugs, parasympathetic inhibitors, opioids or eluxadoline)
• Use of immunosuppressive drugs within the last 6 months or planned use of immunosuppressive drugs during the study
• Patients treated with tricyclic antidepressants
• Serotonin re-uptake inhibitors are allowed if the patient is at stable dose for at least 8 weeks prior to signing informed consent and the dose will remain stable throughout the duration of the study.
• History of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis) and celiac disease (by anamnesis and assessed by tTGA levels)
• Active infection, or abnormalities in laboratory testing, vital signs, or physical examination at screening
• Participation in any other interventional clinical trial within 4 weeks before study participation

Sponsors & Collaborators

• Glock Health, Science and Research GmbH: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

RECRUITING

MeSH Terms

Conditions

Diarrhea

Interventions

Administration, Oral

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Michael Wolzt, Prof. Dr.

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Wolzt, Prof. Dr.

CONTACT

+43 (0)1 40400; michael.wolzt@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 24, 2019
• Study Start: October 2, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)