Clinical trial NCT02431533: The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome
Official title: The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome: A Randomized, Double-Blind Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: IBS-D
diarrhea predominant
Lead sponsor: Pharmabiotix Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Alberta
First posted: 2015-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Probiotics, particularly Bifidobacterium infantis, Sacchromyces boulardii, Lactobacillus plantarum and combination probiotics may help regulate how often people with IBS have bowel movements. Probiotics may also help relieve bloating from gas. Research is continuing to determine which probiotics are best to treat IBS.

PX0612

PX0612 is a probiotic which is composed of the following ingredients contained in a veggie capsule, being one dose:

Bacillus coagulans 200 million colony forming units 16.0mg Bacillus subtilis 100 million colony forming units 4.8mg Enterococcus faecium 100 million colony forming units 0.6mg Fructo-oligosacharride a nutrient for the packaged product 600.0mg Total 621.4 mg Bacillus coagulans is a non-pathogenic, Gram positive, spore forming bacteria that produces lactic acid. Though not normally found in the gut. Bacillus coagulans strains have been used as general nutritional supplements and agents to control constipation and diarrhea in humans and animals.

Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 - 65 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:

1. Abdominal pain or discomfort which is relieved by defecation, and/or associated with a change in frequency of stool and/or consistency of stool
2. 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

Exclusion Criteria:

* 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
* Patients using catheters
* Patients presented with rectal bleeding, weight loss, iron deficiency anemia, nocturnal symptoms and a family history of colorectal cancer, inflammatory bowel disease and celiac spruce
* Patients over 50 diagnosed with Irritable Bowel Syndrome who have not had a colonoscopy in the last 5 years
* Patients who have allergies for the active ingredients or any of the exepients
* Patients presented with any immune-compromised condition (such as AIDS, lymphoma, long term corticosteroid treatment)
* Patients presented with nausea, vomiting and fever 6 \|

Primary outcomes:
measure: Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.
timeFrame: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)
Secondary outcomes:
measure: Differences in Upper Gastrointestinal Symptoms Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.
timeFrame: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)
measure: Differences in Upper Gastrointestinal Symptoms- Vomiting Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.
timeFrame: Baseline compared to Week 12
measure: Changes in the Patient's Assessment of Their Quality of Life Using Short Form(SF)-36 Health Survey PCS (Physical Component Score)
timeFrame: Baseline compared to Week 12 (end of study)
measure: Differences in Abdominal Pain/Discomfort Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.
timeFrame: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)
measure: Differences in Stool Consistency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.
timeFrame: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)
measure: Differences in Stool Frequency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.
timeFrame: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)
measure: Differences in Upper Gastrointestinal Symptoms- Early Satiety
timeFrame: Baseline compared to Week 12
measure: The Difference in Change of Postprandial Fullness Severity
timeFrame: Baseline compared to Week 12
measure: Upper Gastrointestinal Symptoms of Prolonged Digestion
timeFrame: Baseline compared to Week 12
measure: Upper Gastrointestinal Symptom of Nausea
timeFrame: Baseline and Week 12
measure: FBDSI (Functional Bowel Disease Severity Index)
timeFrame: Baseline compared to Week 12
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Lawrence Richer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.