Personalized approach to managing abdominal pain in IBS
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)
This study is testing a new way to help people with IBS and IBD manage their abdominal pain by using an app to track their symptoms and triggers, and comparing it to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT05998577 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance the management of abdominal pain in patients with Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD) by utilizing Experience Sampling Method (ESM) and the Traqq application. Participants will be randomized into either an intervention group, which will use ESM and Traqq to track symptoms and triggers, or a standard care group. The study will analyze the data collected to identify associations between abdominal pain, psychosocial factors, and dietary patterns. The insights gained will help patients and their physicians make informed decisions regarding lifestyle changes and treatment options.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with a diagnosis of IBS or IBD-IBS who can understand Dutch and utilize the ESM and Traqq applications.
Not a fit: Patients who do not meet the diagnostic criteria for IBS or IBD-IBS or those outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved symptom management and quality of life for patients with IBS and IBD.
How similar studies have performed: While the use of ESM in IBS management is promising, this specific combination with Traqq is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria IBS patients * 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 70 years; * Ability to understand and speak the Dutch language * Ability to understand how to utilize the ESM and Traqq applications. Inclusion criteria IBD patients * Patients with IBD diagnosed in accordance with current ECCO guidelines, with IBD- IBS and with chronic abdominal pain, as follows: * MIAH score \<3 * Fecal calprotectin \< 150 ug/g * Fulfilling the Rome IV criteria for IBS. * Age between 18 and 70 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. Exclusion criteria IBS patients * Any organic explanation for the abdominal symptoms; * A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy is present; * Pregnant or lactating at the baseline visit. Exclusion criteria IBD patients * 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.
Where this trial is running
Maastricht, Limburg
- Maastricht UMC+ — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Study coordinator: Daan Bosch, BSc
- Email: daan.bosch@maastrichtuniversity.nl
- Phone: 0433-884295
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.