Evaluating Anorectal Function in Patients with Inflammatory Bowel Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: lucian.marinica-grando@regionorebrolan.se
• Phone: 0046196021794

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.