Status:
NOT_YET_RECRUITING
Psychological and Dietary Treatment in IBS
Lead Sponsor:
Region Örebro County
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal (GI) condition which is strongly associated with dietary and psychosocial factors. Management of IBS remains challenging for prim...
Detailed Description
Part 1 Study design: Cross-sectional observational study. Study population: 200 IBS patients, M/F, age 18-65 years, will be recruited under a period of 4 years from the primary health care in Regi...
Eligibility Criteria
Inclusion
- IBS symptom severity score of at least 175 (moderate to severe symptoms).
- Age 18 to 65 years.
Exclusion
- Abnormal results on standard screening laboratory tests; this means that patients with abnormal thyroid-stimulating hormone (TSH), increased f-calprotectin or positive celiac disease serology will not be included.
- Severe psychiatric, systemic inflammatory diseases, inflammatory bowel disease and other severe diseases such as cancer.
- Current drug or alcohol abuse.
- Inability to complete questionnaires in Swedish.
- Current pharmacological treatment for their IBS symptoms, except for "over the counter" products such as loperamide or fiber.
- Ongoing use of low FODMAP (Fermentable Mono-, di-, oligosaccharides, and polyols) diet. A current lactose free or gluten free diet will not be accepted. Earlier lactose or gluten free diet will be accepted after a wash-out period of at least 2 weeks.
- Current psychological treatment.
- Current psychological treatment.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04770883
Start Date
March 1 2021
End Date
May 31 2026
Last Update
March 2 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Skebäck primary health care center
Örebro, Sweden, 70215