NCT05185609 Assessment of Anorectal Function in Patients With Inflammatory Bowel Disease
| NCT ID | NCT05185609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Örebro County |
| Condition | Inflammatory Bowel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2021-09-01 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 frequently experience such symptoms. The cause is not well understood and the functionality of the bowel in IBD patients is underexplored. Earlier studies show a wide range of results, but most find that patients with IBD in remission are up to four times as likely to report gastrointestinal symptoms when compared to healthy controls. Chronic inflammation may cause changes of the bowel wall, like increased collagen deposits (fibrosis) and thus cause symptoms, but the absence of active inflammation in combination with presence of symptoms may also be regarded as resembling the clinical condition of irritable bowel syndrome (IBS). IBS is characterized by abdominal pain and changes in stool frequency and consistence and is often associated with disorders like depression and anxiety. Up to a third of IBD patients without signs of disease activity meet the criteria for IBS (irritable bowel syndrome. It can be speculated that an IBD diagnosis is a distressing event that can induce mood disorders, and an IBS-like condition. Characterization of IBS patients relies on the Rome IV symptom criteria, symptom severity scales and measurements of rectal sensibility and rectal compliance using a barostat procedure. Motor function assessment relies on anorectal manometry which detects abnormalities of muscle function and coordination. Recently, a standardized high-resolution anorectal manometry protocol (HRAM) was published which also evaluates sensitivity and compliance. The level of agreement between the barostat method and the HRAM testing procedure regarding sensibility and rectal compliance is largely unknown. Recent studies have associated gut microorganisms, genetic factors, and proteins with various aspects of IBD. There is evidence that these potential markers may reflect non-inflammatory processes such as fibrosis. The aim of this study is to explore the anorectal function in symptomatic patients with inactive IBD compared to healthy volunteers and asymptomatic patients, evaluate symptom severity and psychological parameters and perform molecular characterization. The level of agreement of rectal sensitivity and compliance measurements with the barostat method and HRAM protocol will also be evaluated.
Eligibility Criteria
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.
Contact & Investigator
Michiel van Nieuwenhoven, assoc prof
PRINCIPAL INVESTIGATOR
University Hospital Örebro
Frequently Asked Questions
Who can join the NCT05185609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05185609 currently recruiting?
Yes, NCT05185609 is actively recruiting participants. Contact the research team at lucian.marinica-grando@regionorebrolan.se for enrollment information.
Where is the NCT05185609 trial being conducted?
This trial is being conducted at Örebro, Sweden.
Who is sponsoring the NCT05185609 clinical trial?
NCT05185609 is sponsored by Region Örebro County. The principal investigator is Michiel van Nieuwenhoven, assoc prof at University Hospital Örebro. The trial plans to enroll 70 participants.