Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

February 7, 2021 updated by: Doaa abdelaziz, National Hepatology & Tropical Medicine Research Institute

Brief Summary:

This is a randomized, controlled study evaluating metformin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of metformin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

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
    • الغربية
      • Tanta, الغربية, Egypt
        • Tanta University Hospitals
        • Contact:
          • Nahla Khalaf, MD
        • Sub-Investigator:
          • Fatma elgebaly, MD
        • Sub-Investigator:
          • Fatma Khairy, MD
        • Sub-Investigator:
          • Nahla Khalaf, MD

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
  2. Adults (males and/or females) with age range from 18 to 65 years old.
  3. Patients on treatment with 5-aminosalisylic acid (5-ASA)

Exclusion Criteria:

  1. Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
  2. Treatment with systemic or rectal steroids.
  3. Treatment with immunosuppressants.
  4. Previously failed treatment with a sulphasalazine.
  5. Known hypersensitivity to any of study drugs.
  6. Hepatic and renal dysfunction.
  7. Pregnancy and lactation.
  8. History of colorectal carcinoma.
  9. History of complete or partial colectomy.
  10. Current or previous treatment with metformin for females with polycystic ovarian syndrome.
  11. Patients with diabetes mellitus
  12. Patients with history of lactic acidosis
  13. Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
  14. Positive stool culture for enteric pathogens, positive stool ova and parasite exam.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
participants will receive placebo for 8 consecutive weeks in addition to the standard therapy
Drug: Placebo
Placebo
Experimental: Metformin group
participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy
Drug: metformin 500 mg TID Oral Tablet
biguanides derivatives
Other Names:
  • Glucophage XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between the two groups in the expression of colonic (NF)-κB proteins.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

National Hepatology & Tropical Medicine Research Institute

Investigators

  • Principal Investigator: Noha Mansour, PhD, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

February 7, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 7, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 7, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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