Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04750135
• Other study ID #: 21-2019
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 7, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2021
• Source: National Hepatology & Tropical Medicine Research Institute
• Contact: Doaa Hamed, PhD
• Phone: +202 23642494
• Email: Abdelaziz.h.doaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• metformin 500 mg TID Oral Tablet
biguanides derivatives
• Placebo
Placebo

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	???????

Sponsors (1)

Lead Sponsor	Collaborator
National Hepatology & Tropical Medicine Research Institute

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between the two groups in the expression of colonic (NF)-?B proteins.		8 weeks