This study will assess whether alginate oligomers enhance the efficacy of anti-diarrheals, i.e. compounds that block intestinal ion and water secretion.
ID
Source
Brief title
Condition
- Gastrointestinal infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
IC50 values of test compounds for inhibition of the ICM response of rectal
biopsies.
Secondary outcome
IC50 values of test compounds for inhibition of the ICM response in intestinal
cell cultures (organoids).
Histology of biopsies. Gene expression.
Background summary
Accumulation of mucus on the epithelial surface can block the uptake of
small-molecule compounds by the intestinal mucosa, reducing the efficacy of
enterally applied drugs (like anti-diarrheals). We hypothesize that measures
which reduce mucus accumulation and/or -viscosity, will enhance drug uptake and
efficacy
Study objective
This study will assess whether alginate oligomers enhance the efficacy of
anti-diarrheals, i.e. compounds that block intestinal ion and water secretion.
Study design
Rectal biopsies will be obtained from healthy volunteers. The effect of the
alginate oligomers on the efficacy of a small-molecule blocker of intestinal
ion and water secretion will be tested, ex vivo, in the rectal biopsies and
organoids made thereof.
Study burden and risks
The procedure to obtain rectal biopsies can be completed within 20 minutes.
Including anamnesis, the whole
procedure will take about 45 min. Tissue sampling is virtually painless,
although accompanied sporadically with the
loss of minute quantities of blood. The procedure is regularly performed for
screening and research purposes in the
context of Hirschsprung*s disease and cystic fibrosis. From this practice, it
can be deduced that the risk of serious
adverse effects is negligible.
No benefits are associated with participation.
Dr Molenwaterplein 40
Rotterdam 3015GD
NL
Dr Molenwaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Aged 18-55.
Enrollment by informed written consent
Exclusion criteria
Coagulation disorders
Use of anticoagulants.
(Chronic) constipation. (As this may indicate aberrant intestinal ion and fluid
transport.)
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 | NL73623.078.20 |