Fecal microbiota transplantation for improved Fructose catabolism and Insulin sensiTivity In patients with metabolic syndrome

Recruiting

Conditions: metabolic syndrome, insuline resistance

Registration Number: NL-OMON24239

Lead Sponsor: Amsterdam UMC

Brief Summary: n/a

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

Inclusion criteria metabolic syndrome subjects:
•Treatment naïve (no medication use)
•Metabolic syndrome (3 out of 5 NCEP ATPIII criteria with at least fasting glucose = 5.6 mmol/l)
•Aged 18-70 years
•BMI = 25kg/m2
•Low gut microbiome diversity in 3 baseline fecal samples taken during 1 week (average Shannon diversity 4.2 or lower)
•Male/postmenopausal females
•South Asian Surinamese (SAS) or Caucasian descent

Inclusion criteria fecal donors:
•Treatment naïve (no medication use)
•Normal fasting glucose and lipid levels
•aged 18-70 years
•BMI < 25kg/m2
•Male / female gender
•High microbiota diversity in 3 fecal samples taken during 1 week (average Shannon 4.2 or higher) with presence of
Desulfovibrio strains
•South Asian Surinamese (SAS) or Caucasian descent

Exclusion Criteria

Exclusion criteria metabolic syndrome subjects/donors:
•Inability to provide written informed consent
•Antibiotics use in the last 3 months and proton-pump inhibitor use
•Alcohol or nicotine abuse
•Evidence for compromised immunity

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint are changes in insulin sensitivity (assessed by 2 step hyperinsulinemic clamp and CGM) between 0 and 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are changes in (small) intestinal microbiota composition at baseline and after 6 weeks. Also, changes in postprandial fructose challenge test associated plasma (including endogenous ethanol) +24h fecal+urine metabolites, changes in (energy excretion, bile acids and SCFA) 24h feces will be studied between SAS and Dutch metabolic syndrome subjects. Finally, changes in liver steatosis (NAFLD liver MRI) imaging as well as changes in dietary intake at 0 and 6 weeks and engraftment of donor bacterial strains in oral and fecal samples during these 6 weeks will be studied