The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome

NCT02431533 | Completed Results

• 1 other identifier: 01-PBI-2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

IBS is a disorder of movement in the gut. People who have IBS may have diarrhea, constipation, or alternating bouts of both. IBS is not caused by injury or illness. Often the only way doctors can diagnose it is to rule out other conditions through testing.

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

IBS-D; diarrhea predominant

Outcome Measures

Primary Outcomes (1)

• Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.

  For each patient stool frequency was measured as a number of bowel movements per day. To compare stool frequency before and after the treatment, the average for the first 2 run-in weeks (day 1 - day 14) and the last 2 weeks (day 78 - day 91) was calculated. A higher mean score indicates a better outcome, a greater reduction in bowel movements/day and is a positive change. Placebo group- min: -.43 max: 1.43 Study group- min: -.43 max: 1.50

  Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)

Secondary Outcomes (11)

• Differences in Upper Gastrointestinal Symptoms Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.

  Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)

• Differences in Upper Gastrointestinal Symptoms- Vomiting Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.

  Baseline compared to Week 12

• Changes in the Patient's Assessment of Their Quality of Life Using Short Form(SF)-36 Health Survey PCS (Physical Component Score)

  Baseline compared to Week 12 (end of study)

• Differences in Abdominal Pain/Discomfort Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.

  Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)

• Differences in Stool Consistency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.

  Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)

Study Arms (2)

Probiotic PX0612

EXPERIMENTAL

PX0612 is a probiotic contained in a veggie capsule.

Dietary Supplement: PX0612

Di-Calcium Phosphate

PLACEBO COMPARATOR

Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate

Dietary Supplement: Di-Calcium Phosphate

Interventions

PX0612 DIETARY_SUPPLEMENT

PX0612 is a probiotic contained in a veggie capsule.

Probiotic PX0612

Di-Calcium Phosphate DIETARY_SUPPLEMENT

Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate

Di-Calcium Phosphate

Eligibility Criteria

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

You may qualify if:

• Male or female
• years old
• Signed informed consent
• Mild to moderate (using Functional Bowel Disorder Severity Index (FBDSI)) IBS-Diarrhea patient:
• IBS definition will be based on Rome criteria;
• The symptoms of IBS must persist for at least 3 months and must include:
• Abdominal pain or discomfort which is relieved by defecation, and/or associated with a change in frequency of stool and/or consistency of stool
• At least two of the following, at least a quarter of occasions or days (25%):
• A. Altered stool frequency (\> 3 bowel movements/day or \< 3 bowel movements/week) B. Altered stool form (lumpy/hard or loose/watery stools) C. Altered stool passage (straining, urgency or feeling of incomplete evacuation) D. Passage of mucus E. Bloating or feeling of abdominal distention
• Note: Diarrhea is defined as having loose watery stools at least three times per day

You may not qualify if:

• The patient will be excluded from the study if:
• Assessment by the treating investigator showed an evidence for cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, head, ears, eyes, nose and throat, dermatologic/psychiatric, allergy, major surgery or other diseases as revealed by history, physical examination and existing laboratory assessments which may interfere with the administration or 5 \| P a g e
• PX0612 In The Treatment Of Irritable Bowel Syndrome:
• assessment of study medication. This should be confirmed by a pre-study medical examination performed 2 weeks prior the study.
• Pregnant or lactating
• Females at child bearing age will be excluded unless they are using acceptable birth control measures (i.e. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence or a vasectomized partner)
• Patients requiring treatments with non-permitted medication (i.e. 5-HT3 antagonist, spasmolytics, anticholinergics, cholestyramine, anti flatulence agents, metoclopramide, gastric-anti secretory agents (proton pump inhibitors; for indications other than Gastroesophageal Reflux Disease (GERD)), narcotics, anti-diarrheal drugs, and systemic steroids)
• Patients requiring the use of antibiotics either in medicine form of natural (e.g. grapefruit seed extract, olive leaf extract, oil of oregano, colloidal silver and highly concentrated garlic preparations)
• Exercise and the use of complementary and alternative medicine for IBS symptoms (i.e. peppermint oil, cognitive behavior therapy) during the study should be maintained at the same level prior to the study.
• Patients exceeding the treatment limits of permitted medication \[(more than 2 days/week during the study period): alginate, antacids and analgesics (limited to acetaminophen ≤ 1000 mg/day, acetylsalicylic acid or NSAIDS no more than 2 tablets/day), (stable dose throughout the study period, anti-depressants (must be on a stable dose \> 3 months), fiber supplements, psyllium hydrophilic mucilloid, gastric anti secretory agents (only for GERD patients who are on a stable dose \> 3 months; patients should be able to differentiate between IBS and GERD symptoms), acetylsalicylic acid ≤ 325 mg/day, sedatives. Deliverance medications: Mild laxatives only if necessary.\]. Any other medications can be used without limits based on the clinical judgment of the treating investigator.
• Being in another clinical trial 4 weeks before entering the study
• Constipated IBS patients
• IBS-Diarrhea patients with un-treated lactose intolerance
• Regular use of probiotics or using other probiotics during the course of the study
• Patients allergic to milk or soy products

Sponsors & Collaborators

• Pharmabiotix Inc: lead
• University of Alberta: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (5)

• Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.

  PMID: 16678561 BACKGROUND

• Longstreth GF, Wilson A, Knight K, Wong J, Chiou CF, Barghout V, Frech F, Ofman JJ. Irritable bowel syndrome, health care use, and costs: a U.S. managed care perspective. Am J Gastroenterol. 2003 Mar;98(3):600-7. doi: 10.1111/j.1572-0241.2003.07296.x.

  PMID: 12650794 BACKGROUND

• Drossman DA. Review article: an integrated approach to the irritable bowel syndrome. Aliment Pharmacol Ther. 1999 May;13 Suppl 2:3-14. doi: 10.1046/j.1365-2036.1999.0130s2003.x.

  PMID: 10429736 BACKGROUND

• Schoenfeld P, Talley NJ. Measuring successful treatment of irritable bowel syndrome: is "satisfactory relief " enough? Am J Gastroenterol. 2006 May;101(5):1066-8. doi: 10.1111/j.1572-0241.2006.00519.x.

  PMID: 16696786 BACKGROUND

• Dolin BJ. Effects of a proprietary Bacillus coagulans preparation on symptoms of diarrhea-predominant irritable bowel syndrome. Methods Find Exp Clin Pharmacol. 2009 Dec;31(10):655-9. doi: 10.1358/mf.2009.31.10.1441078.

  PMID: 20140275 BACKGROUND

Results Point of Contact

• Title: Mark Cobb
• Organization: Pharmabiotix, Inc

cobbcoinc@aol.com

214-327-4712

Study Officials

• Lawrence Richer

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: April 9, 2015
• First Posted: May 1, 2015
• Study Start: January 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: June 12, 2020
• Results First Posted: October 4, 2019

Record last verified: 2020-06

Locations

CA (1)