Skip to content

Ex vivo experiments to evaluate the role of medication on the colon permeability in microscopic colitis

Ex vivo experiments to evaluate the role of medication on the colon permeability in microscopic colitis - The role of medication on the colon permeability in MC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41154
Enrollment
24
Registered
2014-09-17
Start date
2015-11-10
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

microscopic bowel inflammation microscopic colitis

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In general: aged between 50-75 years, no current use of NSAIDs, PPIs or SSRIs. * For patients in remission: positive diagnosis of microscopic, in remission under medication * For patients with active disease: positive diagnosis of microscopic, collagenous or lymphocytic colitis; confirmed active disease due to relapse, no recent treatment for MC * For healthy controls: no prior positive diagnosis of microscopic, collagenous or lymphocytic colitis.

Exclusion criteria

Exclusion criteria: - Age below 18 years at the time of diagnosis - Use of anticoagulants or immunosuppressive drugs - Severe co-morbidities (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorders and any co-morbidity hindering an endoscopic procedure) - A previous history of any type of chronic colitis (other than MC), irritable bowel syndrome, colon carcinoma or (partial) colectomy - A recent (last year) diagnosis of infectious diarrhea or radiation proctitis. - Use of medication known for influencing intestinal permeability - Excessive alcohol usage (>20 standard units per week) - Not capable of signing an informed consent - Defaecation diary is not matching the predefined stool frequency for the designated patient group (active, remission, control)

Design outcomes

Primary

MeasureTime frame
The primary study outcome is the difference in colon permeability (transpeithelial electrical resistance and FITC-permeation) caused by administration of risk medication between the three groups (MC active, MC remission, MC control)

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)