Status:
UNKNOWN
A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Irritable Bowel Syndrome
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ...
Detailed Description
This is an unicenter, prospective, proof-of-concept randomized controlled, non-blinded intervention study that focuses on two patient populations, with overlapping symptom patterns and treatment appro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 19 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05998577
Start Date
May 19 2023
End Date
May 19 2025
Last Update
October 5 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maastricht UMC+
Maastricht, Limburg, Netherlands, 6229HX