To develop a method to determine Infliximab in feces
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
IFX level in feces
Secondary outcome
not applicable
Background summary
Infliximab is standard treatment for steroid refractary Crohn's diseae or
Ulcerative Colitis. But some patients don't respond or loose response to
induction therapy. Besides the development of antibodies, a subtherapeutic
serum IFX level has been correlated with suboptimal response.
The subtherapeutic IFX level might be explained by fecal loss of IFX due to the
severe ulcers and fulminant diarrea in the acute phase of disease. So far no
method has been described for mesauring IFX in feces.
Study objective
To develop a method to determine Infliximab in feces
Study design
Prospective observational trial
Study burden and risks
The collection of fecal samples can be experienced as burdensome, but no risks
are involved since this a observational study
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
-patients (>18 years) with Ulcerative Colitis or Crohn's Colitis who start on Infliximab therapy
Exclusion criteria
History of previous Infliximab use
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41310.018.12 |