IBD (general)Recruiting
Assessment of Anorectal Function in Patients With Inflammatory Bowel Disease
Observational · No treatment assigned · 1 site · Region Örebro County
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases and Irritable Bowel Syndrome. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 65
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 70 participants are expected to take part.
- Start date: 2021-09-01.
- Main results expected around 2027-12-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Sweden.
Main thing being measured
- Rectal compliance testing with the HRAM and Barostat methods (15 minnutes)
In the researchers’ words
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 frequently experience such symptoms.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases; Irritable Bowel Syndrome |
| Lead sponsor | Region Örebro County |
| Enrollment | 70 (estimated) |
| Start date | 2021-09-01 |
| Primary completion (est.) | 2027-12-30 |
| First posted | 2022-01-11 |
| Last updated | 2022-02-03 |
| Official title | Assessment of Anorectal Function in Healthy Volunteers and Patients With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT05185609 |
Interventions
- Exposure 1: Visceral hypersensitivity or phenotype suggestive of IBS (Other)
Assess the relation between the exposure and the outcome which is persistent symptoms in the patients with quiescent disease. - Exposure 2: Changes in anorectal motor function or compliance. (Other)
Assess the relation between the exposure and the outcome which is persistent symptoms in the patients with quiescent disease.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Criteria: 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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University hospital Örebro | Örebro | Sweden | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.