Status:
RECRUITING
Assessment of Anorectal Function in Patients With Inflammatory Bowel Disease
Lead Sponsor:
Region Örebro County
Conditions:
Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Brief Summary
Active inflammatory bowel disease (IBD) causes disabling symptoms such as diarrhea, involuntary loss of bowel control, abdominal pain and urges to pass stool. However, even patients with inactive IBD ...
Detailed Description
Anorectal function (ARF) disorders in patients with IBD cause disabling symptoms such as fecal incontinence, increases in the stool frequency, urgency and tenesmus. Patients with IBD in remission fre...
Eligibility Criteria
Inclusion
- Healthy volunteers
- Symptomatic IBD patients: Moderate to severe IBD in remission with persistent symptoms as reported by symptom index and short health scale.
- Asymptomatic IBD patients: moderate to severe IBD in remission without symptoms
Exclusion
- Healthy volunteers:
- gastrointestinal disease, functional gastrointestinal symptoms,
- psychiatric disease
- anal or pelvic surgery, inclusive interventions during delivery
- diabetes, cardiovascular, renal, or hepatic disease,
- concurrent or recent treatment with drugs affecting intestinal function or mood (antidepressants), nutritional supplements or herb products affecting intestinal function (probiotics), abuse of alcohol or drugs, and a recent (\< 2 weeks) history of systemic steroid therapy.
- IBD patients
- active disease
- anal or pelvic surgery, inclusive interventions during delivery
- diabetes, cardiovascular, renal, or hepatic disease,
- concurrent or recent treatment with drugs affecting intestinal function or mood (antidepressants), nutritional supplements or herb products affecting intestinal function (probiotics), abuse of alcohol or drugs, and a recent (\< 2 weeks) history of systemic steroid therapy. Patients taking antidiarrhoeal or laxatives can be included after a 48 h washout period.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05185609
Start Date
September 1 2021
End Date
December 30 2027
Last Update
February 3 2022
Active Locations (1)
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1
University hospital Örebro
Örebro, Sweden, 70185