No registrations found.
ID
Source
Brief title
Health condition
metabolic syndrome, fecal therapy
Sponsors and support
PO Box 22660
1100 DD Amsterdam
tel: +31-20-5669111
PO Box 22660
1100 DD Amsterdam
tel: +31-20-5669111
Intervention
Outcome measures
Primary outcome
1. Fecal flora composition;
2. Weight.
Secondary outcome
1. Insulin resistance;
2. Biochemical parameters;
3. Inflammatory parameters;
4. Gut epithelium (duodenal and jejunal mucosal biopsies).
Background summary
Recent research shows that obesity is associated with changed bowel flora composition with a relative abundance of the two dominant bacterial divisions, the Bacteroidetes and the Firmicutes. Interestingly, this specific bacteria associated condition is transmissible: colonization of obese mice with an ‘leanmicrobiota’ results in a significantly greater decrease in total body fat than colonization with a ‘obese microbiota. In addition, Bacteroidetes species are decreased and Firmicutes increased in feces of obese people compared to lean people. Moreover weight correlated with percentage loss of body weight in obese subjects. Changing fecal flora composition in overweight MS patients might therefore be total novel and effective prevention of the rapid increase patients with type 2 diabetes, that is needed so urgently.
This trial is performed which infusion of lean donor feces through a duodenal tube, compared with autologic (patients own feces) transplantation.
Endpoints are changes in faecal flora, weight, insulin resistance and systhemic/biochemical parameters.
Folluw up is 12 weeks
Study objective
Hypothesis: infusion of lean donor feces in obese subjects is effective on weight reduction, systemic inflammatory pathways and insulin resistance.
Study design
1. Baseline;
2. 2days;
3. 2 weeks;
4. 6 weeks;
5. 12 weeks.
Intervention
1. Arm 1: allogenic fecal therapy
(donor feces from lean volunteer);
2. Arm 2: autologic fecal therapy
(patients' own feces).
A. Vrieze
Academic Medical Center, room F4-256
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665983
a.vrieze@amc.uva.nl
A. Vrieze
Academic Medical Center, room F4-256
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665983
a.vrieze@amc.uva.nl
Inclusion criteria
1. Male obese subjects with metabolic syndrome ( at least 3 out of 5 NCEP metabolic syndrome criteria);
2. 21-65 yr.
Exclusion criteria
1. Cardiovascular event;
2. Diabetic kidney failure;
3. Prolonged compromised immunity;
4. Antidiabetic medicine;
5. Lipid lowering medicine.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL1675 |
NTR-old | NTR1776 |
Other | CCMO : 17378 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |