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Fecal microbiota tRAnspLantation uSed TO improve postpraNdial bacterIAl translocation; the RALSTONIA study.

Fecal microbiota tRAnspLantation uSed TO improve postpraNdial bacterIAl translocation; the RALSTONIA study. - RALSTONIA study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47262
Enrollment
36
Registered
2018-03-15
Start date
2015-12-28
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

insulin resistance metabolic syndrome

Interventions

Patients will be randomised to receive either single allogenous donor feces (n=12) or single autologous feces (n=12).
bacterial translocation
gut microbiota
metabolic syndrome

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Metabolic syndrome patients: - Caucasian - BMI >25 kg/m2 - At least 3 out of 5 NCEP metabolic syndrome criteria: fasting plasma glucose *5.6 mmol/l, triglycerides *1.7 mmol/l, waist-circumference >102 cm, HDL-cholesterol 1.04 mmol/l, blood pressure *130/85 mmHg - Scheduled for laparoscopic cholecystectomy or laparoscopic gastric bypass;Lean donors: - BMI 18,5-25 kg/m2

Exclusion criteria

Exclusion criteria: Metabolic syndrome patients: - A history of cardiovascular event (cerebrovascular accident, myocardial infarction or pacemaker implantation) - Use of any medication including proton pump inhibitors and antibiotics in the past three months - (Expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count

Design outcomes

Primary

MeasureTime frame
To investigate whether an oral fat load induces translocation of intestinal bacteria including Ralstonia picket and whether lean donor fecal transplantation affects this.

Secondary

MeasureTime frame
To investigate whether changes in (small) intestinal gut microbiota are related to postprandial bacterial translocation. Moreover, we will investigate changes in visceral and subcutaneous adipose tusse and plasma. Furthermore, we will study changes in 24h feces (triglyceride excretion) and 24h urine (TMAO and oxalic acid).

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)