|- candidate number||5651|
|- NTR Number||NTR1776|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-apr-2009|
|- Secondary IDs||17378 CCMO|
|- Public Title||FATLOSE trial: Fecal Administration To LOSE weight.|
|- Scientific Title||Treatment of overweight and insulin resistance by fecal enema harvested from lean volunteers in patients with metabolic syndrome; the FATLOSE trial.|
|- ACRONYM||FATLOSE trial|
|- hypothesis||Hypothesis: infusion of lean donor feces in obese subjects is effective on weight reduction, systemic inflammatory pathways and insulin resistance.|
|- Healt Condition(s) or Problem(s) studied||Metabolic syndrome|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2009|
|- planned closingdate||1-jan-2011|
|- Target number of participants||20|
|- Interventions||1. Arm 1: allogenic fecal therapy
(donor feces from lean volunteer);|
2. Arm 2: autologic fecal therapy
(patients' own feces).
|- Primary outcome||1. Fecal flora composition;|
|- Secondary outcome||1. Insulin resistance;|
2. Biochemical parameters;
3. Inflammatory parameters;
4. Gut epithelium (duodenal and jejunal mucosal biopsies).
|- Timepoints||1. Baseline;|
3. 2 weeks;
4. 6 weeks;
5. 12 weeks.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. A. Vrieze|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A. Vrieze|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief 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|
|- Main changes (audit trail)|
|- RECORD||24-apr-2009 - 23-sep-2009|