Status:
TERMINATED
Assessment of Responsiveness to Treatment by Experience Sampling Method
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Constipation-predominant Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Brief Summary
Reliable evaluation of symptoms and their improvement during treatment is crucial in both diagnosing and evaluating response to treatment in IBS. Currently used end-of-day evaluations are considered s...
Detailed Description
The primary objective of this study is to assess the internal and external responsiveness of the ESM-PROM in examining changes in symptom scores between baseline and post-treatment. Secondary objectiv...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years;
- A diagnosis of IBS-C according to Rome IV criteria:
- Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: 1) Relation to defecation; 2) Association with a change in stool frequency; 3) Association with a change in stool form (appearance). Criteria fulfilled for the last 3 months with symptom onset at least 6 months ago. Reported stool consistency over the last 3 months: At least 25% of bowel movements are hard and lumpy stools (BSFS 1 or 2) and less than 25% of bowel movements are watery stools (BSFS 6 or 7).
- Negative colonoscopy in the past 5 years prior to inclusion;
- Treatment in primary care unsuccessful for 12 months;
- Ability to understand, read and speak the Dutch language;
- Ability to understand how to utilize the MEASuRE app on a smartphone.
Exclusion
- Appendectomy or cholecystectomy within 2 months or other abdominal surgeries within 6 months before entry into the study;
- A history of laxative abuse;
- Current use of drugs that could initiate constipation (e.g. narcotics);
- Use of any IBS-related drugs possibly causing constipation (e.g. tricyclic antidepressants) are a reason for exclusion, unless usage is on a stable dose for at least 30 days before inclusion and there is no plan to change the dose during the study period.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03336034
Start Date
January 1 2018
End Date
May 1 2022
Last Update
May 25 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maastricht University Medical Center
Maastricht, Netherlands, 6229ER