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Status unknownNCT04750135Updated Feb 11, 2021

Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

A Phase 2 interventional study of metformin 500 mg TID Oral Tablet and Placebo in Ulcerative Colitis and Inflammatory Bowel Diseases, sponsored by National Hepatology & Tropical Medicine Research Institute. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by National Hepatology & Tropical Medicine Research Institute · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Ulcerative Colitis
  • Inflammatory Bowel Diseases
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

National Hepatology & Tropical Medicine Research Institute is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Placebo comparator
    Control group

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

    Drug: 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

Interventions

  • Drugmetformin 500 mg TID Oral Tablet

    biguanides derivatives

    Also known as: Glucophage XR

  • DrugPlacebo

    Placebo

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What researchers measure

Primary outcomes

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

    Time frame: 8 weeks

07

Study locations

1 site
  • Tanta University Hospitals
    Tanta, الغربية, Egypt
    • Nahla Khalaf, MD · Contact
    • MD · Contact
    • Fatma elgebaly, MD · Sub investigator
    • Fatma Khairy, MD · Sub investigator
    • Nahla Khalaf, MD · Sub investigator
08

References and documents

Publications

  • 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. PubMed 20806430 ↗
  • 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. PubMed 18325386 ↗
  • 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. PubMed 29653414 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04750135
Lead sponsor
National Hepatology & Tropical Medicine Research Institute
Responsible party
Doaa abdelaziz (Lecturer at pharmacy practice department, FUE, Egypt, National Hepatology & Tropical Medicine Research Institute) — Principal investigator
First posted
Feb 11, 2021
Start date
Feb 7, 2021 (estimated)
Primary completion
Jun 1, 2021 (estimated)
Completion
Jun 1, 2021 (estimated)
Last update
Feb 11, 2021

Study contacts

Doaa Hamed, PhD
Contact
Abdelaziz.h.doaa@gmail.com
+202 23642494
Noha Mansour, PhD
principal investigator · Mansoura University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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