Irritable Bowel Syndrome With DiarrheaNCT02431533
The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome
A study testing PX0612 and Di-Calcium Phosphate in people with Irritable Bowel Syndrome With Diarrhea, run by Pharmabiotix Inc at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- PX0612 and Di-Calcium Phosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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%):
- 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
Who cannot join
- 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)
Show all 21Show fewer
- 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 |
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome: A Randomized, Double-Blind Placebo Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- PX0612, Di-Calcium Phosphate
- Keywords
- IBS-D, diarrhea predominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PX0612Dietary supplement
PX0612 is a probiotic contained in a veggie capsule.
Di-Calcium PhosphateDietary supplement
Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
| Study group | Role | What they receive |
|---|---|---|
| Probiotic PX0612 | Experimental | PX0612 is a probiotic contained in a veggie capsule. Receives: 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 Receives: Dietary Supplement: Di-Calcium Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Mean change in heartburn between baseline (days 1-14) and weeks 10 and 11 (days 78-91) between the two groups.
A higher mean value indicates a greater reduction in heartburn, better outcome.
Analog Scale from 0-4 was used by participants to rate upper GI symptoms of heartburn (0= no heartburn, 4= incapacitating).
Placebo group- Min: -2.00 Max: 3.00
Treatment group- Min: -2.00 Max: 2.00
Measured: 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.
vomit scale used was from 0-4, the higher the number, the worse the outcome Mean change in vomiting between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in vomiting, better outcome.
Analog Scale from 0-4 was used by participants to rate upper GI symptoms of vomiting(0= none, 4= incapacitating).
Placebo group- Min: 0 Max: 0
Treatment group- Min: -3.00 Max: 0
Measured: 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)
Differences in quality of life phusical component score using SF-36 between the 'intervention' group and the 'placebo' group over the study period. Baseline PCS scores were compared to the end of the study time point. The mean difference between the 2 time points was measured.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. Scoring is based on software program.
Placebo group- Min: -16.16 Max: 6.25
Treatment group- Min: -16.42 Max: 5.46
The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study.
Measured: 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.
Outcome measure is the mean change of abdominal pain, on a scale of 0-4 (0= no pain, 4= incapacitating pain), between baseline and Weeks 10 and 11. A larger change in average abdominal pain indicates a greater reduction in mean abdominal pain score, better outcome.
Min=-.067 for treatment group Min= -.99 for placebo group Max= 1.14 for treatment group Max= 1.63 for placebo group The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study.
Measured: 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.
The stool consistency before and after the treatment was compared, 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 outcome indicates a greater reduction in loose stool/diarrhea (better outcome).
Bristol Stool Chart (1=severe constipation to 7 =severe diarrhea) was the scale used for measurement. The participant reported outcomes were averaged at above time points for comparison.
Min for placebo group: -.70 Max for treatment group: 2.57 Max for placebo group: 1.88
The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study.
Measured: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)
Differences in Stool Frequency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.
Number of stools/day
Measured: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)
Differences in Upper Gastrointestinal Symptoms- Early Satiety
Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Change in rate of early satiety on a scale from 0-4 (higher the score, the worse the outcome) Mean change in early satiety between baseline and week 12 between the two groups.
A higher mean value indicates a greater reduction in early satiety, better outcome.
Analog Scale from 0-4 was used by participants to rate upper GI symptoms of early satiety (0= none, 4= incapacitating).
Placebo group- Min: -2.00 Max: 1.00
Treatment group- Min: -2.00 Max: 2.00
Measured: Baseline compared to Week 12
The Difference in Change of Postprandial Fullness Severity
Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in postprandial fullness between baseline and week 12 between the two groups.
A higher mean value indicates a greater reduction in a postprandial fullness, better outcome.
Analog Scale from 0-4 was used by participants to rate upper GI symptoms of postprandial fullness (0= no postprandial fullness, 4= incapacitating postprandial fullness).
Placebo group- Min: -1.00 Max: 2.00
Treatment group- Min: -1.00 Max: 2.00
Measured: Baseline compared to Week 12
Upper Gastrointestinal Symptoms of Prolonged Digestion
Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in prolonged digestion between baseline and week 12 between the two groups.
A higher mean value indicates a greater reduction in prolonged digestion, better outcome.
Analog Scale from 0-4 was used by participants to rate upper GI symptoms of prolonged digestion (0= none, 4= incapacitating).
Placebo group- Min: -2.00 Max: 1.00
Treatment group- Min: -1.00 Max: 3.00
Measured: Baseline compared to Week 12
Upper Gastrointestinal Symptom of Nausea
Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in nausea between baseline and week 12 between the two groups.
A higher mean value indicates a greater reduction in nausea, better outcome.
Analog Scale from 0-4 was used by participants to rate upper GI symptoms of nausea(0= none, 4= incapacitating).
Placebo group- Min: 0.00 Max: 2.00
Treatment group- Min: -1.00 Max: 1.00
Measured: Baseline and Week 12
FBDSI (Functional Bowel Disease Severity Index)
Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in FBDSI score between baseline and week 12 between the two groups.
A higher mean value indicates a greater reduction in bowel disease severity, better outcome.
Functional Bowel Disease Severity Index was the scale used to determine this outcome. The range on this scale is from 0-500, with 500 indicating the most severe functional bowel disease.
Placebo group- Min: -10.00 Max: 350.00
Treatment group- Min: 0 Max: 300.00
Measured: Baseline compared to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startJan 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmabiotix Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Alberta
- Responsible party
- Sponsor
- Investigators
- Lawrence Richer, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431533
- Sponsor's protocol ID
- 01-PBI-2012
- Status last verified
- Jun 2020
- First submitted
- 9 Apr 2015
- Last updated
- 12 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16678561Longstreth 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.
PubMed 12650794Drossman 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.
PubMed 10429736Schoenfeld 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.
PubMed 16696786Dolin 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.
PubMed 20140275
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome: A Randomized, Double-Blind Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02431533
- Acronym / sponsor ID
- 01-PBI-2012
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Keywords
- IBS-D, diarrhea predominant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pharmabiotix IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Alberta
- Study start
- Jan 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic PX0612 | Experimental | Dietary Supplement: PX0612PX0612 is a probiotic contained in a veggie capsule. |
| Di-Calcium Phosphate | Placebo comparator | Dietary Supplement: Di-Calcium PhosphatePatients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female
- 18 - 65 years old
- Signed informed consent
- Mild to moderate (using Functional Bowel Disorder Severity Index (FBDSI)) IBS-Diarrhea patient:
- Abdominal pain or discomfort which is relieved by defecation, and/or associated with a change in frequency of stool and/or consistency of stool
Key exclusion criteria (21 listed)
- The patient will be excluded from the study if:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PX0612PX0612 is a probiotic contained in a veggie capsule. | Dietary supplement | Probiotic PX0612 |
| Di-Calcium PhosphatePatients 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 |
Primary outcome
Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.
Time frame: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)
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
11 secondary outcomes
Differences in Upper Gastrointestinal Symptoms Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)
Differences in Stool Frequency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.
Time frame: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)
Differences in Upper Gastrointestinal Symptoms- Early Satiety
Time frame: Baseline compared to Week 12
The Difference in Change of Postprandial Fullness Severity
Time frame: Baseline compared to Week 12
Upper Gastrointestinal Symptoms of Prolonged Digestion
Time frame: Baseline compared to Week 12
Upper Gastrointestinal Symptom of Nausea
Time frame: Baseline and Week 12
FBDSI (Functional Bowel Disease Severity Index)
Time frame: Baseline compared to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16678561Longstreth 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.
- Background: PubMed 12650794Longstreth 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.
- Background: PubMed 10429736Drossman 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.
- Background: PubMed 16696786Schoenfeld 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.
- Background: PubMed 20140275Dolin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Richer principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PX0612 and Di-Calcium Phosphate in people with Irritable Bowel Syndrome With Diarrhea, run by Pharmabiotix Inc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. (time frame: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02431533, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.