Metabolic Syndrome
Conditions
Interventions
Twelve MetSyn subjects will receive saline (placebo) whereas another group of twelve MetSyn subjects will receive a faecal filtrate transplant (FFT), which lacks bacteria and mainly consists of phages
Sponsors
Investigator initiated
Eligibility
Inclusion criteria
Inclusion criteria: • Caucasian male/female • Age: =18 years old • BMI: =25 kg/m2 • At least 3 of the following criteria: o Fasting plasma glucose =5.6 mmol/L OR HOMA-IR index =2.5 (HOMA-IR is measured as (fasting insulin (pmol/L) x fasting glucose (mmol/L)) / 135) o Waist-circumference =102 cm o HDL-cholesterol =1.02 mmol/L o Blood pressure =130/85 mmHg o Triglycerides =1.7 mmol/L • Subjects should be able to give informed consent
Exclusion criteria
Exclusion criteria: • A history of cardiovascular event (cerebrovascular accident (CVA), myocardial infarction (MI)) or pacemaker implantation • Use of any medication including proton pump inhibitors, antibiotics and pro-/prebiotics in the past three months or during the study period • (Expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or human immunodeficiency viruses (HIV) infection with a CD4 count 4 weeks), chronic obstipation (3 months), Irritable Bowel Syndrome (IBS) (according to Rome IV criteria) or Inflammatory Bowel Disease (IBD). • Smoking or illicit drug use (MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period • Use of >5 units of alcohol daily on average in the past three months or use of >2 units of alcohol during the study period • History of cholecystectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compare the effect of lean-donor phage transplantation with placebo treatment (saline) on glucose tolerance (via an OGTT) in obese, insulin resistant subjects at risk to develop diabetes. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess and compare changes in gut microbiota and phage composition following phage transplantation and placebo: • An overview of the dynamic changes in gut microbiota and virome population following phage transplantation compared to placebo. • A comparison between phage composition in individuals at risk to develop T2DM at baseline with phage composition in lean, healthy subjects (donors). | — |
Contacts
Public ContactKoen Wortelboer
Amsterdam UMC, location AMC
Outcome results
None listed