In 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…
ID
Bron
Verkorte titel
Aandoening
metabolic syndrome
insulin resistance
gut microbiota
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The 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).
Achtergrond van het onderzoek
In 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.
Doel van het onderzoek
In 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
Onderzoeksopzet
see above
Onderzoeksproduct en/of interventie
Subjects 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
Publiek
Erik Stroes
Amsterdam
The Netherlands
+31 (0)20 5665978
E.S.G.Stroes@amc.uva.nl
Wetenschappelijk
Erik Stroes
Amsterdam
The Netherlands
+31 (0)20 5665978
E.S.G.Stroes@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A 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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL6630 |
NTR-old | NTR6807 |
Ander register | : MEC 2017/158 |