Assessment of Responsiveness to Treatment of the Experience Sampling Method (ESM) in Irritable Bowel Syndrome using linaclotide

Completed

Conditions: Constipation predominant Irritable Bowel Syndrome
10017977

Registration Number: NL-OMON50476

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Diagnosis of IBS-C according to Rome IV criteria; negative colonoscopy in the
past 5 years prior to inclusion; age between 18 and 75 years; 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 Criteria

Appendectomy or cholecystectomy within 2 months or other abdominal surgeries
within 6 months before entry into the study; 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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study outcomes are the proportion of overall responders to linaclotide<br /><br>treatment after 4 and 12 weeks assessed using the ESM-PROM and the conventional<br /><br>end-of-day diary. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary endpoints are symptom scores as reported using the ESM-PROM,<br /><br>concerning abdominal pain, bloating, abdominal fullness, fecal urgency, stool<br /><br>consistency, straining, CSBM frequency and SBM frequency. Additionally, other<br /><br>factors measured using the ESM-PROM, i.e. non-GI physical symptoms,<br /><br>psychological status at the moment of symptom assessment, contextual<br /><br>information regarding the moment of symptom assessment as well as information<br /><br>on food and substance intake.</p><br>