We hypothesize that restoration of gut microbiota diversity (by using donor FMT enriched in Desulfovibrio strains) could have explicit beneficial effects on glucose metabolism and NAFLD (via improved fructose catabolism), which is driven by…
ID
Bron
Verkorte titel
Aandoening
metabolic syndrome, insuline resistance
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary endpoint are changes in insulin sensitivity (assessed by 2 step hyperinsulinemic clamp and CGM) between 0 and 6 weeks.
Achtergrond van het onderzoek
To investigate whether fecal microbial transplantation (FMT) from healthy donors (average Shannon diversity > 4.2 with desulfovibrio) compared to own feces administered through a small intestinal tube alters insulin sensitivity (assessed by 2 step hyperinsulinemic clamp and CGM (freestyle libre) and fructose catabolism in relation to gutmicrobiota composition between 0 and 6 weeks after intervention in patients with metabolic syndrome and low gut microbiota diversity from either South Asian Surinamese(i.e. Surinamese of Hindustani or Pakistani descent) (SAS) or Caucasian Dutch descent
Doel van het onderzoek
We hypothesize that restoration of gut microbiota diversity (by using donor FMT enriched in Desulfovibrio strains) could have explicit beneficial effects on glucose metabolism and NAFLD (via improved fructose catabolism), which is driven by different (fructose derived) metabolites between SAS and Caucasian Dutch metabolic syndrome subjects.
Onderzoeksopzet
0 and 6 weeks
Onderzoeksproduct en/of interventie
(donor) fecal transplantation
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9838 |
| Ander register | METC AMC : 2021/170 |