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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50476

Enrollment

Registered

2017-06-14

Start date

2018-02-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation predominant Irritable Bowel Syndrome

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary study outcomes are the proportion of overall responders to linaclotide treatment after 4 and 12 weeks assessed using the ESM-PROM and the conventional end-of-day diary.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results