The primary objective is the determination of faecal reference values of calprotectin, elastase and alpha-1-antitrypsin after RYGBP.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The determination of faecal reference values of calprotectin, elastase and
alpha-1-antitrypsin after RYGBP.
Secondary outcome
Not applicable.
Background summary
The Roux-en-Y gastric bypass (RYGBP) changes anatomy and function of the
gastrointestinal system. This influences digestion and absorption of food, and
is therefore likely to influence the structure of the faeces as well. In the
clinic, certain faecal values are used to diagnose or rule out certain
diseases, or for follow-up. Calprotectin is upcoming as a marker for
inflammatory bowel disease. Elastase is a marker for pancreas insufficiency.
Alpha-1-antitrypsin is used in the diagnosis of protein-losing enteropathy. A
recent study showed that the faecal values of calprotectin and elastase after
RYGBP differed significantly from the values in healthy controls.
Study objective
The primary objective is the determination of faecal reference values of
calprotectin, elastase and alpha-1-antitrypsin after RYGBP.
Study design
Observational cross-sectional study for which a single faeces sample is
obtained from patients who are at least 1 year after RYGBP.
Study burden and risks
The burden and risks for the participants are minimal. The patient has to
collect a single sample of faeces and send it to the hospital. No extra visits
or investigations are needed.
Louwesweg 6
Amsterdam 1066EC
NL
Louwesweg 6
Amsterdam 1066EC
NL
Listed location countries
Age
Inclusion criteria
Patients who underwent RYGBP one to two years ago.
Exclusion criteria
- Diarrhea at the time of faeces collection
- Use of proton pump inhibitors or NSAIDs and unable to stop.
- An acute gastrointestinal disease at the time of participation or a chronic gastrointestinal disease in the medical history.
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 | NL49803.048.14 |