Rifaximin Improves Gut Dysbiosis in Insulin Resistance an... | NCT03758144

Studies
Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes

NCT03758144

Sponsor

Zagazig University

Status

Unknown status

Last Update Posted

Nov 29, 2018Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Type2 Diabetes

Interventions

Rifaximin 200 MG

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Jul 1, 2019Estimated

First Submitted Date

Nov 16, 2018

First Submission Date that Met QC Criteria

Nov 28, 2018

First Posted Date

Nov 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2018

Last Update Posted Date

Nov 29, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amr Shaaban Hanafy, Assistant professor of medicine, Zagazig UniversityPrincipal Investigator

Lead Sponsor

Zagazig UniversityOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study	Active Comparator		Drug: Rifaximin 200 MG
CONTROL GROUP	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rifaximin 200 MG	Drug	patients with type 2 diabetes and gut dysbiosis will be given rifaximin	study

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diabetes with gut dysbiosis

Exclusion Criteria:

recent antibiotic use
pregnancy
diabetogenic drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amr hanafy, MD	Contact	+201100061861		dr_amr_hanafy@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zagazig University	Recruiting	Zagazig	Sharqia Province	44519	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

personal contact

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078262	Rifaximin

Ancestor Terms

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided