Gut Flora Dependent Metabolism of Dietary Phosphatidylcholine and Cardiovascular Disease

NCT ID: NCT01519310

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-10-31

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).

Detailed Description

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).

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.

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).

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.

Conditions

Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1

Group 1 (Antibiotics/probioitic):

Group Type: ACTIVE_COMPARATOR

Antibiotic (metronidazole and ciprofloxacin)/probiotic

Intervention Type: OTHER

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.

Group 2

Group 2 (Antibiotics/no-probiotic):

Group Type: ACTIVE_COMPARATOR

Antibiotic (metronidazole and ciprofloxacin)/probiotic

Intervention Type: OTHER

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.

Group 3

Group 3 (no-Antibiotics/probiotic):

Group Type: ACTIVE_COMPARATOR

Antibiotic (metronidazole and ciprofloxacin)/probiotic

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

09-988

Identifier Type: -

Identifier Source: org_study_id