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

Completed

• Conditions: insulin resistance; metabolic syndrome; 10018424

• Registration Number: NL-OMON47262
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

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

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 < 240/mm3)
- Type 2 diabetes mellitus
- Smoking;Lean donors:
- Use of any medication including proton pump inhibitors and antibiotics in the past 3 months
- Type 2 diabetes mellitus
- Diarrhea
- Cholecystectomy
- HIV, HAV, HBV, HCV, active CMV, active EBV
- Unsafe sex practice (questionnaire)
- Illicit drug use
- Smoking
- Presence of fecal bacterial pathogens (Salmonella, Shigella, Campylobacter, Yersinia) or parasites
- Positive C. difficile stool test

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate whether an oral fat load induces translocation of intestinal<br /><br>bacteria including Ralstonia picket and whether lean donor fecal<br /><br>transplantation affects this.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate whether changes in (small) intestinal gut microbiota are related<br /><br>to postprandial bacterial translocation. Moreover, we will investigate changes<br /><br>in visceral and subcutaneous adipose tusse and plasma. Furthermore, we will<br /><br>study changes in 24h feces (triglyceride excretion) and 24h urine (TMAO and<br /><br>oxalic acid).</p><br>