TerminatedNot Applicable

Assessment of Responsiveness to Treatment by Experience Sampling Method

Stopped: Slow inclusion rate.

Netherlands16 participantsStarted 2018-01-01

Plain-language 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 sub-optimal and the Experience Sampling Method (ESM) was proposed previously as a more accurate symptom assessment method. Aim of this study is to evaluate the responsiveness of the developed ESM-PROM in assessing changes in abdominal pain and stool frequency after linaclotide treatment of IBS-C patients.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Mean abdominal pain scores as measured by the ESM tool.

Timeframe: 14 weeks (i.e. once during one week before linaclotide treatment, once during one week during linaclotide treatment and once during one week after the 12 week treatment period).

Maximum abdominal pain scores as measured by the ESM tool.

Timeframe: 14 weeks (i.e. once during one week before linaclotide treatment, once during one week during linaclotide treatment and once during one week after the 12 week treatment period).

Trial details

NCT IDNCT03336034

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-01

View on ClinicalTrials.gov More Constipation-predominant Irritable Bowel Syndrome trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean abdominal pain scores as measured by the ESM tool.

Timeframe: 14 weeks (i.e. once during one week before linaclotide treatment, once during one week during linaclotide treatment and once during one week after the 12 week treatment period).

Maximum abdominal pain scores as measured by the ESM tool.

Timeframe: 14 weeks (i.e. once during one week before linaclotide treatment, once during one week during linaclotide treatment and once during one week after the 12 week treatment period).