Back to resultsAssessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis
Primary Purpose
Ulcerative Colitis, Inflammatory Bowel Diseases
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
metformin 500 mg TID Oral Tablet
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- Tanta University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Metformin group
Arm Description
participants will receive placebo for 8 consecutive weeks in addition to the standard therapy
participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy
Outcomes
Primary Outcome Measures
Difference between the two groups in the expression of colonic (NF)-κB proteins.
Secondary Outcome Measures
Full Information
NCT ID
NCT04750135
First Posted
February 7, 2021
Last Updated
February 7, 2021
Sponsor
National Hepatology & Tropical Medicine Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04750135
Brief Title
Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis
Official Title
Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2021 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Hepatology & Tropical Medicine Research Institute
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
participants will receive placebo for 8 consecutive weeks in addition to the standard therapy
Arm Title
Metformin group
Arm Type
Experimental
Arm Description
participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy
Intervention Type
Drug
Intervention Name(s)
metformin 500 mg TID Oral Tablet
Other Intervention Name(s)
Glucophage XR
Intervention Description
biguanides derivatives
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Difference between the two groups in the expression of colonic (NF)-κB proteins.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa Hamed, PhD
Phone
+202 23642494
Email
Abdelaziz.h.doaa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noha Mansour, PhD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
الغربية
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nahla Khalaf, MD
First Name & Middle Initial & Last Name & Degree
MD
First Name & Middle Initial & Last Name & Degree
Fatma elgebaly, MD
First Name & Middle Initial & Last Name & Degree
Fatma Khairy, MD
First Name & Middle Initial & Last Name & Degree
Nahla Khalaf, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20806430
Citation
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.
Results Reference
background
PubMed Identifier
18325386
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.
Results Reference
background
PubMed Identifier
29653414
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.
Results Reference
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Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis
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