- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02718885
Gut Microbiome Mediated Effects of Inulin Supplementation on Mineral and Bone Metabolism in Hemodialysis Patients
July 31, 2018 updated by: Kenneth Wilund, University of Illinois at Urbana-Champaign
The overall objective of the study is to examine the changes within the gut microbiome after the supplementation of inulin and its effect on markers of mineral metabolism and bone turnover.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In this randomized controlled cross-over study, twenty HD patients (10 male/10 female, aged 20-80) will be recruited from local dialysis clinics in Champaign-Urbana, IL.
After baseline testing, patients will be randomized to the intervention group or placebo group (maltodextrin).
Patients will consume inulin (females 10g/day, males 15g/day) or maltodextrin (females 10g/day, males 15g/day) for one month, rest for two weeks (washout period), and continue with the other treatment (either inulin or maltodextrin) for another month.
Outcomes will be assessed at the beginning of each period and after a month of supplementation at both periods.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- University of Illinois at Urbana-Champaign
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Receive HD therapy 3 days per week and for at least 3 months
Exclusion Criteria:
- Sustained hypercalcemia (>3months).
- Previous major gastrointestinal disease diagnosis (e.g., inflammatory bowel disease and celiac disease).
- Antibiotic treatment < 2 weeks prior the start of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: Maltodextrin
|
Females will ingest 2 doses of 5g/maltodextrin for a total of 10g/maltodextrin/day for four weeks Males will ingest 2 doses of 7.5g/maltodextrin for a total of 15g/maltodextrin/day for four weeks
|
ACTIVE_COMPARATOR: Inulin
Inulin-type fructans
|
Females will ingest 2 doses of 5g/inulin for a total of 10g/inulin/day for four weeks Males will ingest 2 doses of 7.5g/inulin for a total of 15g/inulin/day for four weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mineral metabolism
Time Frame: 4 weeks
|
Plasma calcium, phosphorus and magnesium will be assessed by an blood-chemistry autoanalyzer at the beginning and end of each supplementation period.
Additionally, parathyroid hormone and fibroblast-growth factor will be assessed by ELISA.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone biomarkers
Time Frame: 4 weeks
|
Sclerostin, bone-specific alkaline phosphatase and osteoprotegerin will be assessed by ELISA kits at the beginning and end of each period
|
4 weeks
|
Gut-microbiota derived metabolites
Time Frame: 4 weeks
|
Free serum p-cresyl sulfate and indoxyl sulfate: serum (4ml) will be collected on midweek dialysis session and analyzed using an HPLC.
|
4 weeks
|
Gut microbiome
Time Frame: 4 weeks
|
Participants will be asked to collect a complete fecal sample at the beginning and end of Period 1 and 2. V4 regions of the bacterial 16S rRNA gene will be isolated and amplified.
Sequencing will be done through Illumina Mi-seq V3 platform.
General changes in bacterial diversity and taxa will be analyzed through the open software QIIME.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kenneth Wilund, Ph.D., University of Illinois at Urbana-Champaign
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2016
Primary Completion (ACTUAL)
December 1, 2017
Study Completion (ACTUAL)
July 1, 2018
Study Registration Dates
First Submitted
March 18, 2016
First Submitted That Met QC Criteria
March 18, 2016
First Posted (ESTIMATE)
March 24, 2016
Study Record Updates
Last Update Posted (ACTUAL)
August 2, 2018
Last Update Submitted That Met QC Criteria
July 31, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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