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Weight Loss Benefits of Rifaximin in an Intermittent Fasting Diet

NCT04674176 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-12-19

No results posted yet for this study

Summary

The epidemic of overweight and obese patients presents a major challenge in chronic disease prevention and overall health across the world. Since the beginning of this century, it is considered the third most important hazard attributable to burden of disease with approximately 350 million obese people (BMI ≥30.0) and over 1 billion overweight people (BMI ≥ 25) in the world. Mechanistic studies have indicated that the microbiota influences energy utilization from the diet and influences host genes that regulate energy expenditure and storage. Thus, it is proposed that alterations in gut microbiota may play a significant role in weight loss potential.

This study seeks to expand on this idea by evaluating whether the incorporation of Rifaximin in an intermittent fasting (IF) diet plays a significant role in weight loss. Rifaximin is a nonsystemic antibiotic that works primarily in the gut to inhibit bacterial growth. It portrays unique eubiotic properties that induces a positive modulation of gut microbiota, favoring the growth of bacteria beneficial to the host without altering overall composition. Thus we propose an agent such as rifaximin would be essential in developing a positively altered gut microbiome.

Based on studies evaluating Rifaximin's role in positive gut modification, we propose that this can play a critical role in weight loss. Rifaximin may be associated with weight loss as it exerts effects that increases the concentration of bacteria more prominent in lean individuals. The choice of incorporating an intermittent fasting (IF) diet, stems from its success in prior studies. By incorporating periods of voluntary abstinence from food and drink, an IF diet has shown short term weight loss among overweight and obese people. We propose that an IF diet with an antibiotic, like Rifaximin, will create more positive alteration in gut microbiota that creates a greater potential for weight loss overall.

A group of subjects with BMI's ranging from 30-35 will be randomly selected and assigned to an experimental and control group. Each subject will be given clear instructions on how to follow a 14:10 intermittent fasting diet, in which they will fast for 14 hours and be able to eat for 10 hours a day. Patients in the experiment group will additionally receive a short-term low dosage of Rifaximin at the start of their diet. Patients will be evaluated with weekly weigh-ins and basic blood work performed at the start and at the completion of the study. The current hypothesis does not incorporate microbiome evaluation due to cost of the kits and limited funding available for the study.

Conditions

Interventions

DRUG

Rifaximin

550 mg of Rifaximin 3 times a day for 12 days at the start of the diet.

Sponsors & Collaborators

  • Bayhealth Medical Center

    lead OTHER

Principal Investigators

  • Bhavin Dave, MD · Bayhealth Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-01-01
Completion
2022-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04674176 on ClinicalTrials.gov