N/A
N=50
The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome
Irritable Bowel Syndrome With Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT02431533 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. — .46; .21 bowel movements/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PX0612 (Dietary_supplement); Di-Calcium Phosphate (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharmabiotix Inc
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. |
.46; .21 | — |
| SECONDARY Differences in Upper Gastrointestinal Symptoms Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. |
.09; -.09 | — |
| SECONDARY Differences in Upper Gastrointestinal Symptoms- Vomiting Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. |
-.22; 0 | — |
| SECONDARY Changes in the Patient's Assessment of Their Quality of Life Using Short Form(SF)-36 Health Survey PCS (Physical Component Score) |
-2.27; -2.05 | — |
| SECONDARY Differences in Abdominal Pain/Discomfort Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. |
0.35; 0.44 | — |
| SECONDARY Differences in Stool Consistency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. |
0.51; 0.46 | — |
| SECONDARY Differences in Stool Frequency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. |
2.35; 2.39 | — |
| SECONDARY Differences in Upper Gastrointestinal Symptoms- Early Satiety |
.26; -.27 | — |
| SECONDARY The Difference in Change of Postprandial Fullness Severity |
.22; .18 | — |
| SECONDARY Upper Gastrointestinal Symptoms of Prolonged Digestion |
.35; -.05 | — |
| SECONDARY Upper Gastrointestinal Symptom of Nausea |
.09; .32 | — |
| SECONDARY FBDSI (Functional Bowel Disease Severity Index) |
96.26; 133.41 | — |
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.
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:
- 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 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 |
Data sourced from ClinicalTrials.gov (NCT02431533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.