NCT03336034

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

4.3 years

First QC Date

October 25, 2017

Last Update Submit

May 18, 2022

Conditions

Constipation-predominant Irritable Bowel Syndrome

Keywords

IBS-CExperience sampling methodEcological momentary assessmentAbdominal painConstipation

Outcome Measures

Primary Outcomes (2)

  • Mean abdominal pain scores as measured by the ESM tool.

    Weekly average of mean abdominal pain scores per day on the ESM-PROM per period (i.e. baseline, after 4 weeks and after 12 weeks). Mean scores per day will be calculated, followed by calculating the mean of those 7 scores.

    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.

    Weekly average of the maximum abdominal pain scores per day on the ESM-PROM per period (i.e. baseline, after 4 weeks and after 12 weeks). Maximum scores per day will be determined, followed by calculating the mean of those 7 scores.

    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).

Secondary Outcomes (2)

  • Number of bowel movements.

    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).

  • Symptom scores for other symptoms than abdominal pain, as measured by the ESM tool.

    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).

Study Arms (1)

IBS-C

Constipation-predominant irritable bowel syndrome

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients visiting the outpatient department of the Division of Gastroenterology and Hepatology in MUMC+, diagnosed with constipation predominant irritable bowel syndrome (Rome IV), and newly prescribed with linaclotide 290µg once daily are eligible for inclusion.

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Abdominal PainConstipation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Ad AM Masclee, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 8, 2017

Study Start

January 1, 2018

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

May 25, 2022

Record last verified: 2022-05

Locations

NL(1)