Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes

November 28, 2018 updated by: Amr Shaaban Hanafy, Zagazig University

Rifaximin Improves Insulin Resistance in Metabolic Syndrome and Reduces Insulin Requirement in Type 2 Diabetes

Gut Dysbiosis had been involved in some way in the pathogenesis of some extra-intestinal disorders including metabolic syndrome, cardiovascular disease, and obesity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Accumulating evidence had linked metabolic syndrome and diabetes to dysequilibrium in gut microbiota, which are a critical regulator of host metabolism and immune responses. gut microbiota interacts with host signaling pathways, leading to modulation of the endocrine system, immune responses. gut microbial metabolites, in particular, short-chain fatty acids, have been significantly associated with liability to diabetes. patients with positive fecal short-chain fatty acids will be given rifaximin

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diabetes with gut dysbiosis

Exclusion Criteria:

  • recent antibiotic use
  • pregnancy
  • diabetogenic drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: study
Drug: Rifaximin 200 MG
patients with type 2 diabetes and gut dysbiosis will be given rifaximin
No Intervention: CONTROL GROUP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in glycemic control
Time Frame: 3 months
Fasting blood sugar, post-prandial blood sugar (mg/dl)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal symptom questionnaire
Time Frame: 1 month
symptomatic improvement in Dyspepsia, distension, abdominal pain
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in weight
Time Frame: 6 months
Weight loss in kilograms
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4493

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

personal contact

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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