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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.0g G-PUR® capsules | Experimental |
| |
| Placebo capsules | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.0g G-PUR®, oral administration | Device | tid for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of responders for the patient's global assessment of relief using the last four assessments in the treatment period. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
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)
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Wolzt, Prof. Dr. | Contact | +43 (0)1 40400 | 2981 | michael.wolzt@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Michael Wolzt, Prof. Dr. | Department of Clinical Pharmacology, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Recruiting | Vienna | Austria |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000284 | Administration, Oral |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Placebo, oral administration |
| Device |
tid for 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 | Daily Stool Frequency assessed by daily diary entry of the total number of bowel movements within the last 24 hours | 12 weeks |
| Patient compliance with daily diary reporting | 12 weeks |
| ePRO usability using a paper questionnaire | 12 weeks |
| Worst daily abdominal pain using a 11-point NRS | Percentage of responders, defined as the percentage of participants who meet the following criterion for at least 50% of the days with diary entry: Abdominal pain assessed by a 11-point NRS-scale improved at least 30% compared to baseline | 12 weeks |
| Daily stool consistency using the Bristol Stool Form Scale (Type 1 separate hard lumps, like nuts (hard to pass); Type 7 watery, no solid pieces, entirely liquid) | Percentage of responders, defined as the percentage of participants who have ≥50% reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared to baseline | 12 weeks |
| Responder rate (ie weekly and daily) of the combined endpoint: worst daily abdominal pain and daily stool consistency | 12 weeks |
| Additional responder analyses (i.e. weekly and daily) of IBS symptoms listed all above evaluating different change in symptom intensity with treatment (i.e., greater than or equal to 30, 40 and 50 percent change in intensity compared with baseline) | 12 weeks |
| Number of pain-free days | 12 weeks |
| Assessment of gastrointestinal symptoms using the IBS-SSS during each onsite visit; | Proportion of patients having a reduction ≥ 50 on the IBS-SSS system (ranges 0-500). A decrease in 50 or greater in the IBS-SSS is considered a positive response. | 12 weeks |
| Quality of Life using validated generic SF12 questionnaire | 12 weeks |
| Hospital anxiety and depression scale (HADS) | scale measuring anxiety and depression (14 items); likert scale 0 (not at all) to 3 (most of the time); higher scores(summed) indicate presence of anxiety or depression | 12 weeks |
| Stress response using the perceived stress questionnaire | The (Perceived Stress Questionnaire) PSQ consists of 30 items, each of which has to be scored by a test person using a Likert scale (1 for "almost never", 2 for "sometimes", 3 for "frequently" to 4 for "mostly") how often each item/sentence applied during the last month. Each number has a point that reveals the level of stress for each sentence. Points are calculated according to the calculation system of the scale, and for each individual, the final calculation results in the total value between 0 and 100. Higher total values indicate more stress | 12 weeks |
| Use of rescue medication (to be assessed daily) | 12 weeks |
| Exploratory endpoint: bile acid in stool | bile acid excretion in stool before and after 12 weeks treatment | 12 weeks |
| Exploratory endpoint: zonulin in stool | zonulin (ng/ml) in stool before and after 12 weeks treatment | 12 weeks |
| Exploratory endpoint: microbiome in stool | microbiome in stool assessed by 16S gene sequencing before and after 12 weeks treatment | 12 weeks |
| Exploratory endpoint: HBD2 in stool | human beta defensin 2 (HBD2) (ng/ml) in stool before and after 12 weeks treatment | 12 weeks |
| Exploratory endpoint: gluten in stool | gluten (ng/ml) in stool before and after 12 weeks treatment | 12 weeks |
| Exploratory endpoint: IDO in blood | indoleamine-2,3- dioxygenase (IDO) (umol/mmol) in capillary blood before and after 12 weeks treatment | 12 weeks |
| Exploratory endpoint: zonulin in blood | zonulin (ng/ml) in capillary blood before and after 12 weeks treatment | 12 weeks |