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Fecal microbiota transplantation for improved Fructose catabolism and Insulin sensiTivity In patients with metabolic syndrome : the FFIT study

Fecal microbiota transplantation for improved Fructose catabolism and Insulin sensiTivity In patients with metabolic syndrome : the FFIT study - FFIT study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49935
Enrollment
56
Registered
2021-10-29
Start date
2022-02-18
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

insulin resistance/Dm2 microbiota

Interventions

donor fecestransplantaton (allogenic) or fecal transplantation with own feces (autologous)

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: patients: -treatment naive metabolic syndrome/insulin resistant subjects -surinamese asian or caucasian ethnicity - male/postmenopauzal female - age 40-65 years donors: -healthy (no medication use) - enriched gutmicrobiota desulfovibrio levels

Exclusion criteria

Exclusion criteria: -unable to provide written informed consent- - antibiotics / PPI-antacids use in the last 3 months - nicotine/alcohol abuse

Design outcomes

Primary

MeasureTime frame
Primary outcomes are changes in periperhal insulin sensitivity(as determined by stable isotope (6-6-D2) based hyperinsulinemic clamp for calculation of endogenous hepatic glucose prodution). Also, changes in glucose excursions as detrmined by FreeStyle Libre sensors in relation to changes in (oral , small intestinal and fecal) gut microbiota diversity and composition at baseline and after 6 weeks of FMT.

Secondary

MeasureTime frame
Secondary endpoints are changes in post fructose (13c stable isotope) challenge enrichment of metabolites including alcohol in plasma, 24h urine , 24h feces as well as changes in small intestinal fructose receptor expression and fructose oxidation in exhaled air at these timepoints.Other secondary outcomes comprise changes in MRI imaging of hepatic fat content measured before and after FMT as well as changes in fecal and plasma SCFA and bileacid levels.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026