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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | participants will receive placebo for 8 consecutive weeks in addition to the standard therapy |
|
| Metformin group | Experimental | participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin 500 mg TID Oral Tablet | Drug | biguanides derivatives |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the two groups in the expression of colonic (NF)-κB proteins. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doaa Hamed, PhD | Contact | +202 23642494 | Abdelaziz.h.doaa@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Noha Mansour, PhD | Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Tanta | Gharbia Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20806430 | Background | 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. | |
| 18325386 | Background | 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. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo |
|
| 29653414 | Background | 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. |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |