An observational study in Constipation-predominant Irritable Bowel Syndrome, sponsored by Maastricht University Medical Center. Terminated at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-25.
Sponsored by Maastricht University Medical Center · Observational
Among 12 studies in Abdominal Pain with a site in Netherlands — none open to participants now, 1 under way, none of them phase 3. Abdominal Pain · Netherlands.
Among the 12 studies in Abdominal Pain with a site in Netherlands, this one is the only one that started in 2018, is one of 3 observational ones, and was the 10th registered.
387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.
Browse Abdominal Pain studies →None of the 12 studies in Abdominal Pain with a site in Netherlands is open now. The open studies under Abdominal Pain, anywhere →
Of the 33 Abdominal Pain studies recruiting now, 13 (39%) set no upper age limit and 17 (52%) stop at 75 or younger; 10 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2018.
This study's enrollment of 16 is below the median of 127 across 80 observational studies indexed under Abdominal Pain.
Median enrollment 29 across the 9 interventional studies, 184 across the 3 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.
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None of the 12 has an industry lead sponsor. The 3 most frequent:
Maastricht University Medical Center is the lead sponsor of 853 studies on the registry; 114 are open to participants now.
Maastricht University Medical Center has 7 studies filed under Abdominal Pain — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Abdominal Pain with a site in Netherlands, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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).
Exclusion Criteria:
Constipation-predominant irritable bowel syndrome
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.
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).
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.
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).
Number of bowel movements.
Number of complete spontaneous bowel movements per week, 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).
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.
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).
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in May 2022, 52 months.
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This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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