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)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
Netherlands
Maastricht UMC+
RECRUITING
Maastricht
Contact Information
Primary
Daan Bosch, BSc
daan.bosch@maastrichtuniversity.nl
0433-884295
Backup
Zlatan Mujagic, MD, PhD
z.mujagic@maastrichtuniversity.nl
0433-875021
Time Frame
Start Date: 2023-05-19
Estimated Completion Date: 2025-05-19
Participants
Target number of participants: 120
Treatments
Experimental: ESM/Traqq
Use of ESM and Traqq for one week to get a personalised analysis of the abdominal pain and triggerfactors that can be used at the outpatient clinic visit to select an effective treatment option.
No_intervention: Standard care
Will not be using ESM and Traqq, but will only get a standard outpatient clinic visit together with PDSkeuzehulp to make a decision for a treatment.
Sponsors
Leads: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov