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Weight LossPhase 4NCT04674176

Weight Loss Benefits of Rifaximin in an Intermittent Fasting Diet

A Phase 4 study testing Rifaximin in people with Weight Loss, run by Bayhealth Medical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Weight Loss
What is being tested?
Rifaximin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Jan 2021to 1 Jan 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BMI of 30-35

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Bhavin Dave, MD contact

302-257-2782

drbhavindave@gmail.com

United States1 site
  • Bayhealth Medical Center- Dover Family Physicians and GI Consultants Office

    Dover, Delaware, 19901

    Bhavin Dave, 302-257-2782, drbhavindave@gmail.com

    James Fletcher, DO

Other trials in United States

About this study

Official title: The Potential Weight Loss Benefits of Rifaximin in an Intermittent Fasting Diet

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.

Read more

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.

Read the detailed description

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 (Mehrabani, 2018). Although there is a myriad of reasons for obesity, numerous studies have proposed that the intestinal microbiome plays an intrinsic role in overall health and obesity risk. Mechanistic studies have indicated that the microbiota influences energy utilization from the diet and influences host genes that regulate energy expenditure and storage (Davis, 2016). 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 (Ponziani et al.,2017). In addition to its bactericidal and bacteriostatic effects, rifaximin downregulates the inflammatory response triggered by the gut microbes through inhibition of nuclear factor (NF)-kB via the pregnane X receptor (PXR) and reduces the expression of pro-inflammatory cytokines IL-1B and tumor necrosis factor alpha. These characteristics are unique to rifaximin in comparison to other antibiotics, prebiotics and probiotics (such as yogurt). These effects of rifaximin play a crucial role in gut modulation by altering bacterial virulence through inhibition of adhesion, internalization and translocation to modify bacterial metabolism (Ponziani et al.,2017). Probiotic agents such as yogurt function to increase bacterial groups (such as Bacteriodes Lactobacilli and Bifdobacteria) and there is no proven effect on gut modulation specifically. Thus we propose an agent such as rifaximin would be essential in developing a positively altered gut microbiome.

One meta-analysis investigating the associated symptoms of Rifaxamin when treating hepatic encephalopathy found weight loss to be one its side effects. (Eltawil et al.,2012). It is currently unknown whether the potential weight loss is a beneficial result of the drug or secondary to its side effects. However, based on studies evaluating Rifaximin's role in positive gut modification, we propose that this can play a critical role in weight loss. The human body is a host to vast number of microbes intrinsically linked with overall health, including obesity risk. Studies investigating the relationship between obesity and microbiota found that a low fecal bacterial diversity is associated with more marked overall adiposity, dyslipidemia, and impaired glucose homeostasis with higher low-grade inflammation. Additionally, the intestines are dominated by two divisions of bacteria: Bacteriodes and Firmictus. Within the study, obese individuals had more Firmicutes bacteria and nearly 90% less Bacteriodes than the lean individuals (Davis, 2016). This supports the reason in which Rifaximin may be associated with weight loss as it exerts effects that increases the concentration of Bifidobacteria and Bacteriodes species (Ponziani et al.,2017). By altering inflammatory cytokines, Rifaximin also plays a crucial role in improving glucose homeostasis and gut inflammation. Finally, one study investigating weight loss capabilities of rifaximin found that patients had lost a mean of 4.5 lbs in the rifaximin group compared to the control loss of 0.7lbs over a 4 month follow up (Vizuete, 2012).

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 (Ganesan et al,2018). Currently, there are no specific studies evaluating the effects rifaximin has in an IF diet. However, a meta-analysis investigating fasting diets found an alteration of gut microbiota that induced a white adipose tissue to brown adipose tissue transition - which is a beneficial reaction (Li et al, 2020). Additionally, one study investigating microbiome changes specific to a fasting diet found that there was a significantly increased abundance of Bacteriodes fragilis and Akkermansia muciniphila species (Ozkul et al, 2019). As there are already studies investigating the impact of rifaximin and fasting diet effects individually on weight loss, 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. Although rifaximin does have some associated side effects, it is important to note that among numerous studies using Rifaximin, patients who had experienced nausea/anorexia claimed it was mild and did not withdraw from the studies (Ying et al., 2020 and Furnari 2019). Overall, this study aims to objectively determine if the use of Rifaximin with an intermittent fasting diet will improve overall weight loss results.

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. It is important to note, that although we have proposed a change in gut microflora the study will focus on evaluating weight loss results and will later be followed up with another study that evaluates changes in gut microflora through microbiome testing kits. The current hypothesis does not incorporate microbiome evaluation due to cost of the kits and limited funding available for the study.

Conditions
Weight Loss
Being tested
Rifaximin
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RifaximinDrug

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

Study groups in NCT04674176
Study groupRoleWhat they receive
Rifaxamin (R)ExperimentalPatients 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.
Receives: Drug: Rifaximin
ControlNo interventionParticipants in the control group will undergo no intervention and will only be asked to follow an Intermittent fasting diet.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from Baseline weight at 6 months

  2. 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

    Measured: Change from Baseline BMI at 6 months

Secondary outcomes (2)
  1. HbA1C

    HbA1C will be measured at the start and end of the diet to evaluate percent change.

    Measured: Change from Baseline HbA1C at 6 months

  2. Lipids

    Lipid panels will be evaluated at the start and end of the diet.

    Measured: Change from Baseline lipid results at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2020
  2. Study start1 Jan 2021 (estimated)
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04674176
Sponsor's protocol ID
19901
Status last verified
Dec 2020
First submitted
22 Oct 2020
Last updated
19 Dec 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 27795585
  • 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.

    PubMed 22371636
  • 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.

    PubMed 30232597
  • 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.

    PubMed 30202677
  • 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.

    PubMed 32209070
  • 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

  • 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.

    PubMed 31854308
  • 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.

    PubMed 28740337
  • 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.

    PubMed 32470562
  • 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

  • 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.

    PubMed 23507769

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rifaximin in people with Weight Loss, run by Bayhealth Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bhavin Dave, MD (302-257-2782, drbhavindave@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss (time frame: Change from Baseline weight at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04674176, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.

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