A Double-blind Randomized, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Probiotics (UABla-12™ and DDS®-1) on Digestive Health in IBS Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- IBS
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
- Enrollment
- 336
- Locations
- 12
- Primary Endpoint
- Change in abdominal pain severity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
For the current study, the primary outcome is to evaluate the effect of IP on abdominal pain.
The secondary outcome is to assess the effect of IP on IBS-Symptom Severity, IBS-related quality of life, stool form and consistency and on mental status.
Thus providing an effective objective in improving the gut health and symptomatic relief in IBS patients.
Detailed Description
This study aims to determine the effect of probiotics, as the investigational products (IPs) in subjects satisfying the Rome IV criteria for IBS. Three hundred and sixty six subjects between 18 to 70 years of age and with a positive diagnosis of Rome IV IBS criteria (IBS-C, D, M and U types) and moderate to severe abdominal pain intensity will be recruited in a multi-center, double-blind, parallel group, placebo-controlled randomized trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Literate (as defined by the basic capability to read and understand in the languages approved for the study), male and female subjects in age range of 18-70 years.
- •Presence of Rome IV diagnostic criteria for IBS.
Exclusion Criteria
- •Anemic subjects with Hb \< 10 g/dl.
- •Subjects with organic disease (to be ruled out by physician based on prior history and physical examination).
- •Subjects with a history of surgical resection of the stomach, small intestine or large intestine.
- •Subjects with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis.
- •Subjects with complications from infectious enteritis, hyperthyroidism or hypothyroidism.
- •Subjects with a history of any diet-based intolerance (gluten or lactose intolerance).
- •Subjects with a history of drug or alcohol abuse within the past 6 months.
- •Subjects with a history of or complications from malignant tumors.
- •Subjects with severe depression or an anxiety disorder, which could potentially affect the efficacy evaluation (as determined by the qualified investigator).
- •Subjects with uncontrolled hypertension (≥140/90 mm Hg).
Outcomes
Primary Outcomes
Change in abdominal pain severity
Time Frame: 42 days
The change at Day 42 will be assessed by subject dairy.
Secondary Outcomes
- Change in abdominal pain severity(Day 21)
- Change in IBS symptoms(Day 42)
- Change in daily number of stools(Day 42)
- Change in stool consistency(Day 42)
- Change in Quality of Life(Day 42)