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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26108
Enrollment
24
Registered
2015-03-27
Start date
2015-05-01
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, diabetes mellitus

Interventions

Sponsors

AMC-UvA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Male sex • 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 laparascopic gastric bypass • able to give informed consent

Exclusion criteria

Exclusion criteria: • A history of cardiovascular event (CVA, MI or pacemaker implantation) • Use of any medication including PPI 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) • Presence of overt T2D • Smoking

Design outcomes

Primary

MeasureTime frame
changes in postprandial translocation of intestinal bacteria between donor and own ecal transplantation.

Secondary

MeasureTime frame
changes in (small) intestinal bacterial composition related to bacterial translocation. changes in visceral and subcutaneous adipose tissue and inflammatory tone between donor and own fecal transplantation

Contacts

Public ContactM. Nieuwdorp

AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2

m.nieuwdorp@amc.uva.nl+31 (0)20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)