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Ulcerative colitis (UC) is one of the most common types of chronic and non-specific inflammatory bowel diseases (IBD). It is characterized by cytokine-induced continuous and diffuse inflammatory infiltrations into the rectum's mucosa and extends proximally to the colon. Patients with UC predominantly have bloody diarrhea, abdominal pain, fecal urgency, and tenesmus, which extremely alters their quality of life.
Although the precise pathological mechanism of UC remains unclear, several studies have been outlined many factors that could involve in the pathogenesis of UC, including, but not limited to, initiation of the inflammatory response, disruption of oxidant/antioxidant status, dysregulation of the immune response, alteration of gut microbiota, and delaying epithelial barrier healing. Loss of intestinal barrier function and dysregulated immune response are the key events during colitis development
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | Control group (Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months |
|
| Nifuroxazide group | Active Comparator | Patients will receive 1 g mesalamine three times daily plus Nifuroxazide 200 mg two times daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesalamine | Drug | Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the improvement in health-related quality of life | The IBDQ includes 32 questions, The questions are grouped into four categories: bowel symptoms (B), systemic symptoms (S), emotional function (E), and social function (SF). Response options are consistently presented as seven-point scales, scores range from 32-224 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40620467 | Derived | AlRasheed HA, Abdallah MS, El-Khateeb E, Kamal M, Alrubia S, Alsegiani AS, Ahmed TI, Bahaa MM. A Randomized Controlled Pilot Study Evaluating the Safety and Efficacy of Nifuroxazide in Patients with Ulcerative Colitis. Drug Des Devel Ther. 2025 Jun 30;19:5539-5552. doi: 10.2147/DDDT.S522755. eCollection 2025. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| C013150 | nifuroxazide |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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double blinded
| Nifuroxazide | Drug | Nifuroxazide is an oral antibiotic that has been approved as an effective antidiarrheal agent with no side effects in several gastrointestinal infections |
|
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |