NCT05998577Active, not recruiting
A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome
A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome and Inflammatory Bowel Disease Using Experience Sampling Method (ESM) and a Digital Food Diary (Traqq)
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
Apart from its use to provide insight in IBS disease courses and in clinical research, ESM can provide patients with feedback about individual triggers of their symptoms, and thereby function as part of a personalized therapeutic strategy. This is also true for IBD-IBS. Treatment strategies in IBS and IBD-IBS are largely based on reassurance, identification and elimination of triggering factors, and in more severe cases pharmaco- and psychotherapy. The ESM approach has the potential to increase therapeutic efficacy in IBS and IBD-IBS and will assist patients in disease self-management. The Traqq application can provide more detailed information about the dietary pattern of IBS and IBD-IBS patients. Traqq in combination with ESM will give an overview of abdominal pain and associated symptoms and psychosocial factors are exposed to during the day. The insight provided using ESM and Traqq may improve patient understanding of their personal symptom dynamics and triggers, as well as the physician's insight into the symptom patters of the specific patients, which may aid treatment choice and eventually improve the outcome of any treatment provided in daily clinical care.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 11 Aug 2023
- Start date
- May 2023
- Primary completion date
- Oct 2026
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05998577
What you commit to
- Study type: Interventional
- Planned participants: 120
- From May 2023 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy is present;
Other
- Any organic explanation for the abdominal symptoms;
- Pregnant or lactating at the baseline visit.
- Uncertainty about the absence of active inflammation
- Uncertainty about other explanatory causes for the GI symptoms, such as bile acid malabsorption, intestinal stenosis, or small intestinal bacterial overgrowth;
- Pregnant or lactating at the baseline visit.
Who the study is looking for
- A diagnosis of IBS according to Rome IV criteria, as follows:
- 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:
- Related to defecation;
- Associated with a change in stool frequency; oAssociated with a change in stool form (appearance).
- Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- Minimal baseline score of 150 points on the IBS-SSS scale
- Age between 18 and 80 years;
- Ability to understand and speak the Dutch language
- Ability to understand how to utilize the ESM and Traqq applications.
- Patients with IBD diagnosed in accordance with current ECCO guidelines, with IBD- IBS and with chronic abdominal pain, as follows:
- MIAH score \<3 and/or
- Fecal calprotectin \< 150 ug/g or negative IUS or colonoscopy and
- Fulfilling the Rome IV criteria for IBS.
- Age between 18 and 80 years;
- Minimal baseline score of 150 points on the IBS-SSS scale
- Ability to understand and speak the Dutch language
- Ability to understand how to utilize the ESM and Traqq applications.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.