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van CCT (UK)

van CCT (UK)

Effect of duodenal infusion of Eubacterium hallii on gene expression and postprandial glucose metabolism in males with metabolic syndrome

- candidate number28170
- NTR NumberNTR6807
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-nov-2017
- Secondary IDsMEC 2017/158 
- Public TitleEffect of duodenal infusion of Eubacterium hallii on gene expression and postprandial glucose metabolism in males with metabolic syndrome
- Scientific TitleEffect of duodenal infusion of Eubacterium hallii on gene expression and postprandial glucose metabolism in males with metabolic syndrome
- hypothesisIn this randomised, double-blind, placebo-controlled single centre study we propose to study the effect of duodenal infusion of single E. hallii treatment (administered via duodenal tube) on small intestinal gene expression, bacterial composition and (postprandial) glucose excursions in male subjects with metabolic syndrome
- Healt Condition(s) or Problem(s) studiedInsulin resistance, Metabolic syndrome, Gut microbiota
- Inclusion criteriaIn order to be eligible to participate in this study, patients must meet all of the following criteria:
- Caucasian males
- 21 to 69 years-old
- body mass index (BMI) 25 to 43 kg/m2
- At least 3 out of 5 NCEP metabolic syndrome criteria: fasting plasma glucose ≥ 5.6 mmol/l and/or HOMA-IR ≥ 2.5, triglycerides ≥ 1.6 mmol/l, waist-circumference > 102 cm HDL-cholesterol ≤ 1.04 mmol/l, blood pressure ≥ 130/85 mmHg
- Exclusion criteriaA history of cardiovascular event (myocardial infarction or pacemaker implantation), smoking, cholecystectomy, use of medication including proton pump inhibitors (PPI as this influences intestinal microbiota composition see ref 3), 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). Subjects are also excluded if they have experienced excessive weightloss of >10% in the last months or have overt untreated GI disease/abnormal bowelhabits; moreover, if their levels of plasma aspartate aminotransferase and alanine aminotransferase are 2.5 times or more the upper limit of the normal range; if they have a 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); or overt Dm2.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2017
- planned closingdate1-mrt-2019
- Target number of participants12
- InterventionsSubjects will be given duodenal infusion of 10 ml E. hallii suspension with a total concentration of 10e9 cells in 10% glycerol or 10ml 10 % glycerol only
- Primary outcomeThe primary endpoint is effect on duodenal E. hallii levels as well as small intestinal gene expression (small intestinal biopsy) 6 hours after duodenal infusion of either E. hallii 10e9 cells in 10 ml glycerol 10% (active compound) OR 10ml of 10% glycerol alone (placebo).
- Secondary outcomeSecondary endpoints are effect upon intervention
-(postprandial) glucose and metabolite during standardized mixed meal test
-changes in (postprandial) glucose excursions using continue glucose meter (Freestyle libre) in the days after intervention
-changes in E. hallii and other microbiota in fecal samples collected at baseline, 24h and week 1 and week 4 after intervention.
- effect on dietary intake (by online dietary lists).
- Timepointssee above
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- Publications
- Brief summaryIn this study we aim to study effect of single dose treatment with butyrate producing bacterial strain Eubacterium hallii versus placebo on small intestinal gene expression , intestinal e hallii levels, effect on (postprandial ) glucose and plasma metabolites excursions as well as changes in intestinal microbiota composition and effect on dietary intake.
- Main changes (audit trail)
- RECORD9-nov-2017 - 26-nov-2017

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