Glory: Gut Flora Dependent Metabolism of Dietary Phosphatidylcholine and Cardiovascular Disease

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01519310

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Nutrition	Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic	Early Phase 1

Detailed Description

Metabolism is a process that turns foods we eat into fuel for our bodies. Choline is nutrient found in a type of fat commonly found in foods. There is evidence that choline metabolism by bacteria in the intestines may be linked to cardiac risk.

This single center study will randomize 30 normal, healthy volunteers to 1 of 3 groups:

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.

The antibiotics to be used will be metronidazole (500 mg twice daily) and ciprofloxacin (500 mg daily) for one week. The probiotics to be used will be one serving size of standard flavored yogurt (approximately 170 g) twice daily for up to three weeks.

Study visits will occur at baseline, 1 week, and 4 weeks. Blood and urine samples will be collected at the start of each visit. Subjects will then eat 2 hard boiled eggs and be given a standard medical isotope. Additional blood samples will be obtained at 1, 2, 3, 4, and 6 hours, and a urine sample will be collected at 6 hours. Samples will be analyzed for choline levels, its byproducts, and isotope levels.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Gut Flora Dependent Metabolism of Dietary Phosphatidylcholine and Cardiovascular Disease

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 Group 1 (Antibiotics/probioitic):	Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic 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.
Active Comparator: Group 2 Group 2 (Antibiotics/no-probiotic):	Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic 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.
Active Comparator: Group 3 Group 3 (no-Antibiotics/probiotic):	Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic 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.

Arm

Intervention/Treatment

Active Comparator: Group 1

Group 1 (Antibiotics/probioitic):

Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic

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.

Active Comparator: Group 2

Group 2 (Antibiotics/no-probiotic):

Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic

Active Comparator: Group 3

Group 3 (no-Antibiotics/probiotic):

Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic

Outcome Measures

Primary Outcome Measures

Primary Outcome [December 2016]
Phosphatidylcholine derived gut flora metabolites

Secondary Outcome Measures

Secondary Outcome Measures [December 2016]
Cardiometabolic risk markers

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Men and women age 18 years or above.
Able to provide informed consent and comply with study protocol

Exclusion Criteria:

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.