Randomized placebo-controlled pilot study to determine the effect of probiotics on vitamin K status in renal transplant recipients
- Conditions
- Osteoporose100644771001329610014523
- Registration Number
- NL-OMON56610
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
1. Adult renal transplant recipient >1 year post transplantation
2. Signed informed consent
1. Renal transplant recipient <1 year post transplantation
2. Consuming probiotic supplements in the past 3 months
3. Patients receiving any form of antibiotic treatment in the past 3 months
4. Any supplementation of Vitamin K (e.g. multivitamin)
5. Medical history of blood clotting disorders (hypercoagulable states) and
increased risk of thrombosis (history of myocardial infarction, percutaneous
transluminal angioplasty/stenting of coronary of peripheral arteries, bypass
operation, intermittent claudication, amputation for vascular reasons,
transient ischemic attack (TIA) or ischemic cerebrovascular accident).
6. Gastrointestinal disorders or undergone digestive tract surgery (except
appendectomy)
7. Use of medication that would interfere with the study parameters: Vitamin K
antagonists or fytomenadion
8. Reported slimming or medically prescribed diet
9. Pregnancy, lactation or a female planning to conceive within the study
period (a pregnancy test will be performed if there is any doubt regarding a
potential pregnancy).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the difference in vitamin K status as assessed by<br /><br>plasma dp-ucMGP between the 2 groups after 12 weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To determine the effect of a daily sachet of 4 gram freeze-dried probiotics<br /><br>producing 180 µg vitamin K2 in 24-hour urine on vitamin K metabolites 5C and<br /><br>7C-aglycone, and vitamin K1 and MK4 and MK-7 in stool samples after 12 weeks in<br /><br>participants.<br /><br>2. Impact of the probiotic on the composition of the gut microbiome.<br /><br>3. Assess the affect of the probiotic on serum markers for low grade<br /><br>inflammation (high-sensitivity C-reactive protein) and endothelial dysfunction<br /><br>(soluble vascular endothelium adhesion molecule 1 and soluble intercellular<br /><br>adhesion molecule 1) will also be assessed</p><br>