Primary objective of this study is to assess the responsiveness effect size of the ESM-PROM in examining changes in symptom scores between baseline and post-treatment. Secondary objectives are to identify differences in characteristics between…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background 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.
Study objective
Primary objective of this study is to assess the responsiveness effect size of
the ESM-PROM in examining changes in symptom scores between baseline and
post-treatment. Secondary objectives are to identify differences in
characteristics between responders and non-responders to linaclotide and to
assess for side effects of linaclotide treatment, using the ESM-PROM.
Study design
This is a prospective, observational, single-group, open-label study, initiated
and performed in Maastricht University Medical Center (MUMC+).
Study burden and risks
The burden that is associated with participation in this study comprises
completing the ESM-PROM several times a day, which might be time-consuming and
possibly interrupts daily life due to its random character. Furthermore, the
burden is limited to completing an end-of-day symptom diary and IBS-SSS and
GSRS-IBS questionnaire. However, participating does not bring along important
risks. A potential disadvantage of study participation is that patients will
have to postpone linaclotide treatment with one week (i.e. pre-treatment ESM).
However, this is not considered harmful to the patient. No direct benefits are
expected, since the study does not contain any interventions. All in all, the
risks in this study are considered not disproportional in association with the
benefits.
UNS 50
Maastricht 6229ER
NL
UNS 50
Maastricht 6229ER
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03336034 |
| CCMO | NL60925.068.17 |