NCT04750135

Brief Summary

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.

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
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

February 7, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 7, 2021

Last Update Submit

February 7, 2021

Conditions

Ulcerative ColitisInflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • Difference between the two groups in the expression of colonic (NF)-κB proteins.

    8 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

participants will receive placebo for 8 consecutive weeks in addition to the standard therapy

Drug: Placebo

Metformin group

EXPERIMENTAL

participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy

Drug: metformin 500 mg TID Oral Tablet

Interventions

metformin 500 mg TID Oral TabletDRUG

biguanides derivatives

Also known as: Glucophage XR
Metformin group
PlaceboDRUG

Placebo

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, Egypt

Location

Related Publications (3)

  • Hegazy SK, El-Bedewy MM. Effect of probiotics on pro-inflammatory cytokines and NF-kappaB activation in ulcerative colitis. World J Gastroenterol. 2010 Sep 7;16(33):4145-51. doi: 10.3748/wjg.v16.i33.4145.

    PMID: 20806430BACKGROUND

  • Lewis JD, Lichtenstein GR, Deren JJ, Sands BE, Hanauer SB, Katz JA, Lashner B, Present DH, Chuai S, Ellenberg JH, Nessel L, Wu GD; Rosiglitazone for Ulcerative Colitis Study Group. Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial. Gastroenterology. 2008 Mar;134(3):688-95. doi: 10.1053/j.gastro.2007.12.012. Epub 2007 Dec 7.

    PMID: 18325386BACKGROUND

  • Samman FS, Elaidy SM, Essawy SS, Hassan MS. New insights on the modulatory roles of metformin or alpha-lipoic acid versus their combination in dextran sulfate sodium-induced chronic colitis in rats. Pharmacol Rep. 2018 Jun;70(3):488-496. doi: 10.1016/j.pharep.2017.11.015. Epub 2017 Nov 24.

    PMID: 29653414BACKGROUND

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Interventions

Metformin

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Noha Mansour, PhD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doaa Hamed, PhD

CONTACT

+202 23642494Abdelaziz.h.doaa@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at pharmacy practice department, FUE, Egypt

Study Record Dates

First Submitted

February 7, 2021

First Posted

February 11, 2021

Study Start

February 7, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations

EG(1)