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


- candidate number21876
- NTR NumberNTR5141
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mrt-2015
- Secondary IDs2015_014 METC
- Public TitleFecal microbiota tRAnspLantation uSed TO improve postpraNdial bacterIAl translocation; the RALSTONIA study
- Scientific TitleFecal microbiota tRAnspLantation uSed TO improve postpraNdial bacterIAl translocation; the RALSTONIA study
- ACRONYMRALSTONIA trial
- hypothesiswe hypothesize that translocation of Gram- negative intestinal bacteria is associated with changes in (small) intestinal microbiota composition and can be influenced by fecal microbiota transplantation.
- Healt Condition(s) or Problem(s) studiedMetabolic syndrome, Diabetes Mellitus
- 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 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2015
- planned closingdate31-dec-2017
- Target number of participants24
- Interventionsfecal transplantation
- Primary outcomechanges in postprandial translocation of intestinal bacteria between donor and own ecal transplantation.
- Secondary outcomechanges 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
- Timepoints0 and 3/4 weeks
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryA relation exists between gutmicrobiota composition, plasma bacterial composition as well as adpose tissue bacterial signatures. We will thus study whether changes in gutmicrobiota composition using fecal transplantation affects bacterial signature in periferpheral tissue (blood/adipose tissue)
- Main changes (audit trail)
- RECORD27-mrt-2015 - 1-mei-2015


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