About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
gastrointestinal disease, functional gastrointestinal symptoms,
psychiatric disease
anal or pelvic surgery, inclusive interventions during delivery
diabetes, cardiovascular, renal, or hepatic disease,
Trial population
Remission is defined as endoscopic absence of active inflammation and f-calprotectin \< 100 mg/kg. Moderate to severe disease is defined as patients treated with the immune modulating drugs thiopurine or methotrexate, and/or biological drugs infliximab, adalimumab, golimumab, vedolizumab or ustekinumab. Presence of symptoms is evaluated by the short health scale and symptom index questionnaires that all IBD patients fill before their visit to the outpatient ward.
Trial design
Case-control
Retrospective
Treatments tested in this trial
Exposure 1: Visceral hypersensitivity or phenotype suggestive of IBS
Other interventionAssess 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 interventionAssess the relation between the exposure and the outcome which is persistent symptoms in the patients with quiescent disease.
Treatment groups
Trial outcomes
Primary outcomes
Rectal compliance testing with the HRAM and Barostat methods
RC is defined as the relation between volume (ml) respective pressure (mmHg) at half the maximum volume observed and at thresholds for first sensation, first urge, intense urge and maximum tolerated volume.
Rectal sensitivity testing with whit the HRAM and Barostat methods
RS is defined as the volume (ml) respective pressure (mmHg) observed at 4 (HRAM) respective 5 (Barostat) predefined sensation thresholds.
Anal squeeze pressure
Anal pressure in mmHg assessed from the best of three short squeezes (5seconds) and a prolonged squeeze of 30 seconds during the HRAM investigation.
Anal rest pressure
Anal rest pressure in mmHg assessed during the HRAM investigation.
Secondary outcomes
Cough reflex during HRAM
Recto anal inhibitory reflex is defined as the drop in anal rest pressure observed after inflating a balloon in the rectum to 60 ml. The studies are interpreted as positive or negative and the amplitude of the pressure change is recorded.
RAIR reflex during HRAM
Cough reflex is the increase in anal pressure during cough. The studies are interpreted as positive or negative and the amplitude of the pressure change is recorded.
The adaptive function of the rectum during barostat investigation
The adaptive function of the rectum is defined as the change (increase) in volume necessary to maintain the same rectal pressure during the random phasic distensions of the barostat investigation.
The aggregate sensation intensity scores for gas
The visual analogue scale scores, in mm, marked by the patients at each distension during the random phasic distension part of the barostat study.
Sponsors and contacts
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