Skip to content

Randomized placebo-controlled pilot study to determine the effect of probiotics on vitamin K status in renal transplant recipients

Randomized placebo-controlled pilot study to determine the effect of probiotics on vitamin K status in renal transplant recipients - Probiotics and vitamin K2 status

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56610
Enrollment
20
Registered
2024-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporose

Interventions

Participants will take one dose of oral probiotic or placebo daily for 12 weeks. The daily dose will consist of 1 sachet of 4 gram probiotics or placebo per day dissolved in 200 ml luke warm water.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Adult renal transplant recipient >1 year post transplantation 2. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Renal transplant recipient

Design outcomes

Primary

MeasureTime frame
The main study parameter is the difference in vitamin K status as assessed by plasma dp-ucMGP between the 2 groups after 12 weeks.

Secondary

MeasureTime frame
1. To determine the effect of a daily sachet of 4 gram freeze-dried probiotics producing 180 µg vitamin K2 in 24-hour urine on vitamin K metabolites 5C and 7C-aglycone, and vitamin K1 and MK4 and MK-7 in stool samples after 12 weeks in participants. 2. Impact of the probiotic on the composition of the gut microbiome. 3. Assess the affect of the probiotic on serum markers for low grade inflammation (high-sensitivity C-reactive protein) and endothelial dysfunction (soluble vascular endothelium adhesion molecule 1 and soluble intercellular adhesion molecule 1) will also be assessed

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)