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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24239

Enrollment

Registered

2021-10-29

Start date

2021-10-31

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

metabolic syndrome, insuline resistance

Interventions

(donor) fecal transplantation

Eligibility

Inclusion criteria

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: 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactMax Nieuwdorp

AMC

m.nieuwdorp@amsterdamumc.nl0031 20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)