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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44478

Enrollment

Registered

2014-09-23

Start date

2014-12-16

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome

Interventions

Subjects will be given 100 ml Eubacterium halli suspension per day for 28 days. Increasing dosages of 10e7, 10e9 and 10e11 cells/ vial(dissolved in total volume of 100ml milk) will be tested (n=9 su

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)