Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

NCT05553704 | Completed Phase 2

• 1 other identifier: 3422
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the change in partial mayo score index

  The Partial Mayo Score index is a non-invasive clinical scale used to assess the severity of ulcerative colitis. It is a composite of sub scores from three categories, including stool frequency, rectal bleeding, and physician's global assessment, with a total score ranging from 0-9

  6 months

Secondary Outcomes (1)

• The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

this group will take mesalamine 1 gm three times daily for 6 months

metformin group

ACTIVE COMPARATOR

this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months

Drug: Metformin

Interventions

Metformin DRUG

metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily

metformin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Both males and females will be included
• Negative pregnancy test and effective contraception

You may not qualify if:

• Breast feeding
• Significant liver and kidney function abnormalities
• Diabetic patients
• Colorectal cancer patients
• Patients with severe UC
• Patients taking rectal or systemic steroids
• Patients taking immunosuppressives or biological therapies
• Addiction to alcohol and / or drugs
• Known allergy to the studied medications

Sponsors & Collaborators

• Tanta University: lead
• Mounir Hussein Bahgat Internal Medicine Department Mansoura University: collaborator
• Maha Mohamed Maher Internal Medicine Department Mansoura University: collaborator

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, 35511, Egypt

Location

Related Publications (2)

• Binsaleh AY, El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Elmasry TA, Alrubia S, Alsegiani AS, Eldesoqui M, Bahaa MM. The adjunctive role of metformin in patients with mild to moderate ulcerative colitis: a randomized controlled study. Front Pharmacol. 2025 Mar 19;16:1507009. doi: 10.3389/fphar.2025.1507009. eCollection 2025.

  PMID: 40191419 DERIVED

• El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Bahaa MM. Repurposing metformin as adjuvant therapy in patients with ulcerative colitis treated with mesalamine: A randomized controlled double-blinded study. Int Immunopharmacol. 2024 Sep 10;138:112541. doi: 10.1016/j.intimp.2024.112541. Epub 2024 Jun 24.

  PMID: 38917525 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Metformin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: November 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

EG (1)