Gut Flora Dependent Metabolism of Dietary Phosphatidylcholine and Cardiovascular Disease
Glory
1 other identifier
interventional
4
1 country
1
Brief Summary
The purpose of this study is to see if intestinal bacteria plays a role in choline metabolism (a form of choline monitored in this study is called phosphatidylcholine, also known as lecithin). This study will help to determine if choline metabolism is affected by short-term antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating yogurt).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Apr 2010
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 23, 2012
CompletedFirst Posted
Study publicly available on registry
January 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMarch 3, 2016
March 1, 2016
4.5 years
January 23, 2012
March 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Outcome
Phosphatidylcholine derived gut flora metabolites
December 2016
Secondary Outcomes (1)
Secondary Outcome Measures
December 2016
Study Arms (3)
Group 1
ACTIVE COMPARATORGroup 1 (Antibiotics/probioitic):
Group 2
ACTIVE COMPARATORGroup 2 (Antibiotics/no-probiotic):
Group 3
ACTIVE COMPARATORGroup 3 (no-Antibiotics/probiotic):
Interventions
Antibiotic cocktail/yogurt as follows: Group 1: antibiotics for 1 week, followed by probiotics for 3 weeks; Group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks. Group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks.
Eligibility Criteria
You may qualify if:
- Men and women age 18 years or above.
- Able to provide informed consent and comply with study protocol
You may not qualify if:
- Significant chronic illness or end-organ dysfunction, including known history of heart failure, renal failure, pulmonary disease, or hematologic diseases.
- Active infection or received antibiotics within 2 months of study enrollment
- Use of OTC probiotic within past 2 months, or ingestion of yogurt within past month
- Chronic gastrointestinal disorders, or intolerance to probiotic therapy
- Allergies to eggs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2012
First Posted
January 26, 2012
Study Start
April 1, 2010
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
March 3, 2016
Record last verified: 2016-03