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‘Effect of fecal transplant harvested from bariatric surgery subjects on lipid and glucose metabolism in subjects with metabolic syndrome;the FEBALIGO trial


- candidate number15909
- NTR NumberNTR4327
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-dec-2013
- Secondary IDsMEC 2013/090  
- Public Title‘Effect of fecal transplant harvested from bariatric surgery subjects on lipid and glucose metabolism in subjects with metabolic syndrome;the FEBALIGO trial
- Scientific Title‘Effect of fecal transplant harvested from bariatric surgery subjects on lipid and glucose metabolism in subjects with metabolic syndrome; the FEBALIGO trial
- ACRONYMFEBALIGO trial
- hypothesisTo investigate the effect of gutmicrobiota infusion harvested from pre- vs post-RYGB donors on microbiome-induced, lipid-mediated insulin resistance in insulin resistant subjects.
- Healt Condition(s) or Problem(s) studiedInsulin resistance
- Inclusion criteriaMale obese treatment naieve subjects with metabolic syndrome (n=22, 21 to 65 years-old; with metabolic syndrome Able to give informed consent.
- Exclusion criteriahistory of cardiovascular event (MI or pacemaker implantation) cholecystectomy, use of medication including PPI and antibiotics past three months, (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 19-dec-2013
- planned closingdate1-apr-2015
- Target number of participants44
- Interventionsfecal transplantation using either feces from subjects after bariatric surgery or subjects before bariatric surgery in metablic syndrome
- Primary outcomechanges in insulin sensitivity (hyperinsulinemic euglycemic clamp with ([6,6-2H2]labeled glucose) [1,1,2,3,3-2H5]labeled glycerol) and fecal energy excretion (caloric bomb) between baseline and 2 weeks after treatment.
- Secondary outcomeChanges in adipose tissue inflammation in subcutaneous adipose tissue (biopsy) for insulin signalling cascade in relation to metabolic genes and macrophage counts; Intestinal transit time; fecal bileacids and shortchain fatty acids; Gut microbiota composition in small duodenal biopsies and feces
- Timepointsmetabolic syndrome subjects: baseline and 2 weeks after fecal transplantation. donors: baseline
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summarythis study aims to dissect causality of intestinal microbiota in metabolic improvements (insulin resistance) seen in postbariatric surgery subjects using fecal transplantation.
- Main changes (audit trail)
- RECORD19-dec-2013 - 24-mei-2017


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