Constipation-predominant Irritable Bowel SyndromeNCT03336034
Assessment of Responsiveness to Treatment by Experience Sampling Method
An observational study of Constipation-predominant Irritable Bowel Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation-predominant Irritable Bowel Syndrome
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2018to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Responsiveness to Treatment of the Experience Sampling Method (ESM) in Irritable Bowel Syndrome (IBS) Using Linaclotide
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.
Read the detailed description
The primary objective of this study is to assess the internal and external responsiveness 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. This is a prospective, observational, single-group, open-label study, initiated and performed in Maastricht University Medical Center (MUMC+). The study population will conclude 30 IBS-C subjects that are newly prescribed with linaclotide by their treating physician at the outpatient department of gastroenterology and hepatology in the Maastricht UMC+. Primary study outcomes are the weekly average of the mean and maximum abdominal pain scores per day on the ESM-PROM per period (i.e. baseline, after 4 weeks and after 12 weeks). The ESM-PROM is completed during 7 consecutive days at each period and therefore, the measurements start one week before linaclotide treatment (baseline) and end one week after finishing linaclotide treatment (after 12 weeks). Further endpoints are the change scores of abdominal pain between pre- and post-treatment, measured using the ESM-PROM. Additionally, the proportion of overall responders to linaclotide treatment after 4 and 12 weeks assessed using the conventional end-of-day diary will be used to evaluate external responsiveness. Further 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. Secondary outcomes are 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.
- Keywords
- IBS-C, Experience sampling method, Ecological momentary assessment, Abdominal pain, Constipation
- Medical subject headings
- Abdominal Pain, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBS-C | Constipation-predominant irritable bowel syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Number of complete spontaneous bowel movements per week, as measured by the ESM tool.
Measured: 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.
Symptom scores for non-GI physical symptoms, psychological symptoms, contextual information and information on food and drug intake.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Jan 2018
- Primary completion1 May 2022
- Study completion1 May 2022
Why it stopped: Slow inclusion rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ad AM Masclee, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336034
- Sponsor's protocol ID
- METC 173007
- Other IDs
- NL60925.068.17
- Status last verified
- May 2022
- First submitted
- 25 Oct 2017
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Responsiveness to Treatment of the Experience Sampling Method (ESM) in Irritable Bowel Syndrome (IBS) Using Linaclotide
- ClinicalTrials.gov ID
- NCT03336034
- Acronym / sponsor ID
- METC 173007
- Keywords
- IBS-C, Experience sampling method, Ecological momentary assessment, Abdominal pain, Constipation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow inclusion rate.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study is to assess the internal and external responsiveness 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. This is a prospective, observational, single-group, open-label study, initiated and performed in Maastricht University Medical Center (MUMC+). The study population will conclude 30 IBS-C subjects that are newly prescribed with linaclotide by their treating physician at the outpatient department of gastroenterology and hepatology in the Maastricht UMC+. Primary study outcomes are the weekly average of the mean and maximum abdominal pain scores per day on the ESM-PROM per period (i.e. baseline, after 4 weeks and after 12 weeks). The ESM-PROM is completed during 7 consecutive days at each period and therefore, the measurements start one week before linaclotide treatment (baseline) and end one week after finishing linaclotide treatment (after 12 weeks). Further endpoints are the change scores of abdominal pain between pre- and post-treatment, measured using the ESM-PROM. Additionally, the proportion of overall responders to linaclotide treatment after 4 and 12 weeks assessed using the conventional end-of-day diary will be used to evaluate external responsiveness. Further 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. Secondary outcomes are 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBS-C | – | –Constipation-predominant irritable bowel syndrome |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean abdominal pain scores as measured by the ESM tool.
Time frame: 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).
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.
Maximum abdominal pain scores as measured by the ESM tool.
Time frame: 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).
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.
2 secondary outcomes
Number of bowel movements.
Time frame: 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.
Time frame: 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).
Results and safety
The study was stopped early (reason given: Slow inclusion rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ad AM Masclee, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation-predominant Irritable Bowel Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow inclusion rate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean abdominal pain scores as measured by the ESM tool. (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.