A Prospective Study to Analyze the Short-Term and Long-Term Effectiveness of WinHealths DTx Platform in Managing and Improving Symptoms of Irritable Bowel Syndrome (IBS).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in IBS symptoms based on any change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500 through WinHealth.Care (heal O gut application).
Study Overview
Brief Summary
This is a prospective study conducted on a sample population of patients clinically diagnosed by a physician that the patient suffers from Irritable Bowel Syndrome (IBS). The participants will be recruited from a gastroenterology hospital/clinic. The patients, who meet eligibility criteria, will be enrolled in the study after obtaining their consent.
All patients will go through the initial assessment where details about their demographics, symptoms severity, and lifestyle including dietary and exercise habits, and other relevant medical or surgical history will be taken.
The sample population will then be divided into two cohorts of patients. To reduce the risk of bias, both cohorts will have a good representation and equal distribution of patient demographics (Age, weight, sex, etc.) and their IBS symptom severity score (IBS-SSS).
Primary Purpose: Management and Improvisation through WinHealth’s DTx platform in preventing and improving symptoms of IBS, leading to better patient outcomes and improved quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female participants aged between 18 and 65 years.
- •Clinically diagnosed with Irritable Bowel Syndrome (IBS) as determined by Rome III or IV Criteria.
- •No restrictions on type of IBS.
- •Willing and able to provide informed consent to participate in the study.
- •Willing to complete the study
- •Agreement to input information about their abdominal pain and bowel movements on a daily basis into WinHealth app
- •Agreement to have their anonymized data stored in the cloud for up to 2 years after the conclusion of the study, and to have the data used for research purposes.
- •Agreement to maintain stable dosage of IBS medications during the course of treatment and not to add new IBS medication or stop current IBS medications unless directed to do so by the participants treating physician.
- •Changes in treatment will be captured using a concomitant medication assessment.
- •Consistent submission of Pain Severity scores via the WinHealth app (data submitted on 80% or more of days in the symptom tracking window)
- •Access to an Android smart phone or other compatible device to access the DTx platform.
Exclusion Criteria
- •Active major psychiatric illness which would potentially interfere with participation in the study
- •Participants with Active eating disorder
- •BMI of 40 or higher
- •Participants with severe comorbidities that may significantly affect the study results.
- •Individuals with a history of major abdominal surgeries (intestinal, reflection and bariatric), and cancer patients under treatment.
- •Pregnant or breastfeeding individuals.
- •Enrolment in active clinical trial/ experimental therapy within the last 30 days.
Outcomes
Primary Outcomes
Change in IBS symptoms based on any change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500 through WinHealth.Care (heal O gut application).
Time Frame: Change in IBS symptoms based on any change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500
Secondary Outcomes
- To analyze the impact of the DTx platform on the overall quality of life (QoL) of IBS IBS-SSS,DASS21 & EQ-5D-5L in patients.(2. To clinically validate the effectiveness of WinHealth’s DTX application in improving the adherence to medications)
Investigators
Dr Rami Reddy Yalaka
Star Hospitals