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FATLOSE 2 study *Single versus multiple fecal transplants harvested from lean volunteers on lipid and glucose metabolism in subjects with metabolic syndrome; the FATLOSE 2 trial (Fecal Administration To LOSE insulin resistance)*

FATLOSE 2 study *Single versus multiple fecal transplants harvested from lean volunteers on lipid and glucose metabolism in subjects with metabolic syndrome; the FATLOSE 2 trial (Fecal Administration To LOSE insulin resistance)* - FATLOSE2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35735
Enrollment
100
Registered
2011-10-11
Start date
2011-12-11
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

gut microbiota metabolic syndrome

Interventions

Patients will be treated with infusion of allogenic or autologous feces by duodenal tube after bowel lavage Patients will be randomized by sealed envelopes to the following 6 treatment arms: 1. si

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male obese subjects with metabolic syndrome, age 21-65, BMI 30-43 kg/m2

Exclusion criteria

Exclusion criteria: cardiovascular event (MI or pacemaker implantation), use of medication including PPI and antibiotics, (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count

Design outcomes

Primary

MeasureTime frame
The primary endpoint changes in fecal flora composition and shortchain fatty acid metabolism in fecal samples after 3, 6, 10, 13, 16 and 20 weeks.—

Secondary

MeasureTime frame
Secondary endpoints are changes in insulin resistance/fatty acid metabolism (assessed by hyperinsulinemic normoglycemic clamp and stable isotope glucose/palmitate infusion) and postprandrial lipidmetabolism (mixed meal test) at baseline and after 10 and 20 weeks). Finally, changes in gutregulatory hormones in plasma (leptin, adiponectin and GLP-1) will be assessed.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)