Personalized approach to managing abdominal pain in IBS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Maastricht UMC+
  Maastricht, Limburg, Netherlands Recruiting

Study contacts

• Study coordinator: Daan Bosch, BSc
• Email: daan.bosch@maastrichtuniversity.nl
• Phone: 0433-884295

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.