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

Phase 2

Completed

Conditions: Metabolic syndrome
10018424

Registration Number: NL-OMON44478

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 27

Inclusion Criteria

otherwise healthy 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 and/or HOMA-IR>2.5, fasting triglycerides > 1.6 mmol/l, waist circumference > 102 cm and not on concomitant medication and regular stool pattern.

Exclusion Criteria

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), 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 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is safety (plasma biochemistry eg hepatic<br /><br>/inflammatory/cholesterol markers) in relation to efficacy (changes in fecal E.<br /><br>hallii levels and insulin sensitivity as assessed by hyperinsulinemic clamp<br /><br>using [6,6 2H2]-glucose and [1,1,2,3,3]-2H5-glycerol infusion) between<br /><br>baseline and 4 weeks of treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include daily dietary intake and quality of life and bowel<br /><br>habits (monitored using standardized questionnaires) as well as intestinal<br /><br>microbiota composition (including fecal E. hallii) in fecal samples at 1, 2, 4<br /><br>weeks after treatment. Moreover, effects on bile acid metabolism in 24h feces<br /><br>and hepatic MRI (for liverfat content) at baseline and after 4 weeks. Finally,<br /><br>washout of fecal E.hallii will be determined after cessation of therapy at 4<br /><br>weeks by collecting fecal samples at 5 and 6 weeks.</p><br>