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Dosefinding trial studying effect of 4 weeks Intervention on safety and efficacy in males with Metabolic syndrome with oral Eubacterium hallii


- candidate number21021
- NTR NumberNTR4913
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-nov-2014
- Secondary IDsMEC 2014_215  
- Public TitleDosefinding trial studying effect of 4 weeks Intervention on safety and efficacy in males with Metabolic syndrome with oral Eubacterium hallii
- Scientific TitleDosefinding trial studying effect of 4 weeks Intervention on safety and efficacy in males with Metabolic syndrome with oral Eubacterium hallii
- ACRONYMDIME study
- hypothesisWe hypothesize that daily oral administration of increasing dosages of Eubacterium hallii, an anaerobic intestinal bacterial strain, can exert beneficial effects on insulin sensitivity and liver fat.
- Healt Condition(s) or Problem(s) studiedMetabolic syndrome, Obesity, Insulin resistance
- Inclusion criteria-Caucasian obese subjects with metabolic syndrome (males, aged 21 to 69 years-old; body mass index (BMI) 25 to 43 kg/m2, fasting plasma glucose > 5.6 mmol/l, fasting triglycerides > 1.7 mmol/l, waist circumference > 102 cm)
- No concomitant medication
- Regular stool pattern
- Exclusion criteria- History of cardiovascular event (myocardial infarction or pacemaker implantation)
- Cholecystectomy
- Use of medication including proton pump inhibitors
- Oral anticoagulants and/or oral antibiotics in the past three months
- (Expected) prolonged compromised immunity (e.g. due to recent cytotoxic chemotherapy or HIV-infection with a CD4 count < 240).
- Excessive weightloss of >10% in the last months
- Overt untreated GI disease/abnormal bowelhabits;
- Levels of plasma aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) are 2.5 times or more the upper limit of the normal range
- History of heavy alcohol use (>12 to 15 g of alcohol per day, or >12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits)
- Overt DM2
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-nov-2014
- planned closingdate31-dec-2016
- Target number of participants27
- Interventionsincreasing daily dosages of eubacterium hallii (10e6, 10e8 and 10e10 cells/ml) for 4 weeks in male subjects with metabolic syndrome
- Primary outcome- Safety (plasma biochemistry eg hepatic /inflammatory/cholesterol markers) and increase in fecal E. hallii levels upon increasing dosages of daily oral Ehallii treatment
- Insulin sensitivity as assessed by hyperinsulinemic clamp using stable isotope infusion) at baseline and 4 weeks upon increasing dosages of daily oral Ehallii treatment
- Secondary outcome- Effect on daily dietary intake and bowel habits (monitored using standardized questionnaires)
- Intestinal fecal microbiota composition (including fecal E. hallii) upon increasing dosages of daily oral Ehallii treatment
- Effects on bile acid metabolism in 24h feces
- Liver fat content (hepatic MRI) upon increasing dosages of daily oral Ehallii treatment
- Persistance of fecal E.hallii after cessation of 4 weeks treatment by collecting fecal samples at 5 and 6 weeks.
- Timepoints0,1,2,4,5,6 weeks
- Trial web site
- 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)
- Publications
- Brief summaryBased on our animal data, we will investigate the optimal dose of daily oral E.halliii treatment with respect to safety, improvement in insulin sensitivity (clamp) and reduced liver fat content (NAFLD/NASH on liver MRI) in male subjects with metabolic syndrome.
- Main changes (audit trail)
- RECORD22-nov-2014 - 12-feb-2017


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