Evaluating Anorectal Function in Patients with Inflammatory Bowel Disease

Assessment of Anorectal Function in Healthy Volunteers and Patients With Inflammatory Bowel Disease

This study is testing how well the muscles and nerves in the rectum work in people with inflammatory bowel disease to see if they have ongoing gut issues, even if they feel fine.

Quick facts

• Study type: Observational
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Region Örebro County (other)
• Locations: 1 site (Örebro)
• Trial ID: NCT05185609 on ClinicalTrials.gov

What this trial studies

This observational study assesses anorectal function in patients with inflammatory bowel disease (IBD) to understand the prevalence and nature of gastrointestinal symptoms, even in those in remission. It utilizes anorectal manometry to evaluate sphincter function and rectal sensitivity, aiming to uncover potential links between chronic inflammation, visceral hypersensitivity, and symptoms resembling irritable bowel syndrome (IBS). The study includes both symptomatic and asymptomatic IBD patients, as well as healthy volunteers, to compare findings and better understand the underlying mechanisms of bowel dysfunction in IBD. The goal is to shed light on how chronic conditions may lead to persistent gastrointestinal issues.

Who should consider this trial

Good fit: Ideal candidates include patients with moderate to severe IBD in remission who are experiencing persistent symptoms, as well as healthy volunteers without gastrointestinal diseases.

Not a fit: Patients with active IBD or those with significant comorbidities affecting gastrointestinal function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients with IBD experiencing persistent gastrointestinal symptoms.

How similar studies have performed: Previous studies have shown varying results regarding anorectal function in IBD, indicating that while the approach has been explored, this specific focus on symptom persistence in remission is relatively novel.

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.

Where this trial is running

Örebro

• University hospital Örebro — Örebro, Sweden (RECRUITING)

Study contacts

• Principal investigator: Michiel van Nieuwenhoven, assoc prof — University Hospital Örebro
• Study coordinator: Lucian Marinica Grando, phd student

Conditions: Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Anorectal function, Anorectal manometry, Rectal barostat