FATLOSE trial: Fecal Administration To LOSE weight.

Treatment of overweight and insulin resistance by fecal enema harvested from lean volunteers in patients with metabolic syndrome; the FATLOSE trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23407

Enrollment

Registered

2009-04-24

Start date

2009-01-01

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, fecal therapy

Interventions

1. Arm 1: allogenic fecal therapy (donor feces from lean volunteer)

2. Arm 2: autologic fecal therapy (patients' own feces).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male obese subjects with metabolic syndrome ( at least 3 out of 5 NCEP metabolic syndrome criteria); 2. 21-65 yr.

Exclusion criteria

Exclusion criteria: 1. Cardiovascular event; 2. Diabetic kidney failure; 3. Prolonged compromised immunity; 4. Antidiabetic medicine; 5. Lipid lowering medicine.

Design outcomes

Primary

Measure	Time frame
1. Fecal flora composition; 2. Weight.	—

Secondary

Measure	Time frame
1. Insulin resistance; 2. Biochemical parameters; 3. Inflammatory parameters; 4. Gut epithelium (duodenal and jejunal mucosal biopsies).	—

Contacts

Public ContactA. Vrieze

PO Box 22660

a.vrieze@amc.uva.nl+31 (0)20 5665983

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)