NCT03758144

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

November 16, 2018

Last Update Submit

November 28, 2018

Conditions

Type2 Diabetes

Keywords

gut dysbiosisrifaximininsulin resistance

Outcome Measures

Primary Outcomes (1)

  • change in glycemic control

    Fasting blood sugar, post-prandial blood sugar (mg/dl)

    3 months

Secondary Outcomes (1)

  • Gastrointestinal symptom questionnaire

    1 month

Other Outcomes (1)

  • change in weight

    6 months

Study Arms (2)

study

ACTIVE COMPARATOR
Drug: Rifaximin 200 MG

CONTROL GROUP

NO INTERVENTION

Interventions

Rifaximin 200 MGDRUG

patients with type 2 diabetes and gut dysbiosis will be given rifaximin

study

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diabetes with gut dysbiosis

You may not qualify if:

  • recent antibiotic use
  • pregnancy
  • diabetogenic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Central Study Contacts

Amr hanafy, MD

CONTACT

+201100061861dr_amr_hanafy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of medicine

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 29, 2018

Study Start

November 1, 2018

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

November 29, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

personal contact

Locations

EG(1)