Weight Loss Benefits of Rifaximin in an Intermittent Fasting Diet

NCT04674176 | Unknown Phase 4 FDA Drug

• 1 other identifier: 19901
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Weight Loss

Outcome Measures

Primary Outcomes (2)

• Weight loss

  Patients will be asked to come in for weekly weigh-ins on the same day of the week and time of day (morning, noon or evening). Weight loss will be evaluated as pounds lost or % pounds lost.

  Change from Baseline weight at 6 months

• BMI

  BMI will be calculated at the beginning and at the end of the diet. Weight and height will be combined to report BMI in kg/m\^2

  Change from Baseline BMI at 6 months

Secondary Outcomes (2)

• HbA1C

  Change from Baseline HbA1C at 6 months

• Lipids

  Change from Baseline lipid results at 6 months

Study Arms (2)

Rifaxamin (R)

EXPERIMENTAL

Patients in the experimental group will receive additional instructions to take 550 mg of Rifaximin 3 times a day for 12 days at the start of the diet. The experimental group will be provided the required doses of Rifaximin at the initial weigh-in and office visit.

Drug: Rifaximin

Control

NO INTERVENTION

Participants in the control group will undergo no intervention and will only be asked to follow an Intermittent fasting diet.

Interventions

Rifaximin DRUG

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

Rifaxamin (R)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI of 30-35

You may not qualify if:

• Underlying conditions such as hypertension, hyperlipidemia, diabetes, etc.
• BMI out of range listed above
• Inability to participate in an intermittent fasting diet
• Pregnant patients, as rifaximin should be used with caution in pregnancy due to limited data. (Subjects of childbearing age will undergo a baseline pregnancy test prior to starting the study)

Sponsors & Collaborators

• Bayhealth Medical Center: lead

Study Sites (1)

Bayhealth Medical Center- Dover Family Physicians and GI Consultants Office

Dover, Delaware, 19901, United States

Location

Related Publications (11)

• Davis CD. The Gut Microbiome and Its Role in Obesity. Nutr Today. 2016 Jul-Aug;51(4):167-174. doi: 10.1097/NT.0000000000000167.

  PMID: 27795585 BACKGROUND

• Eltawil KM, Laryea M, Peltekian K, Molinari M. Rifaximin vs. conventional oral therapy for hepatic encephalopathy: a meta-analysis. World J Gastroenterol. 2012 Feb 28;18(8):767-77. doi: 10.3748/wjg.v18.i8.767.

  PMID: 22371636 BACKGROUND

• Furnari M, De Alessandri A, Cresta F, Haupt M, Bassi M, Calvi A, Haupt R, Bodini G, Ahmed I, Bagnasco F, Giannini EG, Casciaro R. The role of small intestinal bacterial overgrowth in cystic fibrosis: a randomized case-controlled clinical trial with rifaximin. J Gastroenterol. 2019 Mar;54(3):261-270. doi: 10.1007/s00535-018-1509-4. Epub 2018 Sep 19.

  PMID: 30232597 BACKGROUND

• Ganesan K, Habboush Y, Sultan S. Intermittent Fasting: The Choice for a Healthier Lifestyle. Cureus. 2018 Jul 9;10(7):e2947. doi: 10.7759/cureus.2947.

  PMID: 30202677 BACKGROUND

• Li L, Su Y, Li F, Wang Y, Ma Z, Li Z, Su J. The effects of daily fasting hours on shaping gut microbiota in mice. BMC Microbiol. 2020 Mar 24;20(1):65. doi: 10.1186/s12866-020-01754-2.

  PMID: 32209070 BACKGROUND

• Mehrabani J, Ganjifar ZK (2018). Overweight and obesity: a brief challenge on prevalence, complications and physical activity among men and women.MOJ Womens Health;7(1):19-24. DOI: 10.15406/mojwh.2018.07.0016

  BACKGROUND

• Ozkul C, Yalinay M, Karakan T. Islamic fasting leads to an increased abundance of Akkermansia muciniphila and Bacteroides fragilis group: A preliminary study on intermittent fasting. Turk J Gastroenterol. 2019 Dec;30(12):1030-1035. doi: 10.5152/tjg.2019.19185.

  PMID: 31854308 BACKGROUND

• Ponziani FR, Zocco MA, D'Aversa F, Pompili M, Gasbarrini A. Eubiotic properties of rifaximin: Disruption of the traditional concepts in gut microbiota modulation. World J Gastroenterol. 2017 Jul 7;23(25):4491-4499. doi: 10.3748/wjg.v23.i25.4491.

  PMID: 28740337 BACKGROUND

• Li Y, Hong G, Yang M, Li G, Jin Y, Xiong H, Qian W, Hou X. Fecal bacteria can predict the efficacy of rifaximin in patients with diarrhea-predominant irritable bowel syndrome. Pharmacol Res. 2020 Sep;159:104936. doi: 10.1016/j.phrs.2020.104936. Epub 2020 May 26.

  PMID: 32470562 BACKGROUND

• Vizuete, John MD, MPH2; Randall, Charles MD1; Taboada, Carlo MD, et al (2012). Rifaximin for the Treatment of Weight Loss. American Journal of Gastroenterology, 590, Vol. 107

  BACKGROUND

• Zullo A, Ridola L, Hassan C. Rifaximin therapy and Clostridium difficile infection: a note of caution. J Clin Gastroenterol. 2013 Sep;47(8):737. doi: 10.1097/MCG.0b013e31828bea4b. No abstract available.

  PMID: 23507769 BACKGROUND

MeSH Terms

Conditions

Weight Loss

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Bhavin Dave, MD

  Bayhealth Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhavin Dave, MD

CONTACT

302-257-2782; drbhavindave@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bayhealth Gastroenterology Specialist

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: December 19, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)