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| Name | Class |
|---|---|
| Hend El-Said Abo Mansour, Faculty of Pharmacy, Menoufia University | UNKNOWN |
| Monir Hussein Bahgat, Faculty of Medicine, Mansura University | UNKNOWN |
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Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator-activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent.
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.
PPARα has been proposed as a key lipid metabolism modulator and regulator of inflammation. There are three isotypes of PPAR (α, β and ȣ) which have distinct but overlapping functions.
Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment for hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator- activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Mesalamine group will receive 1 g mesalamine three times daily for 6 months |
|
| Fenofibrate group | Active Comparator | Fenofibrate group will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesalamine | Drug | Mesalamine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management. It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL) | HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO) | The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta Unuversity | Tanta | 31527 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41330887 | Derived | Aldossary KM, Abdallah MS, Kamal N, Bahgat MM, Alrubia S, Alsegiani AS, Bahaa MM, Hassan AS, El-Khateeb E. Therapeutic Modulation of IL-6/STAT-3 and Nitric Oxide by Fenofibrate in Patients With Ulcerative Colitis: A Randomized Controlled Pilot Study. Pharmacotherapy. 2025 Dec;45(12):840-851. doi: 10.1002/phar.70088. Epub 2025 Dec 2. |
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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 |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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double-blind
| Fenofibrate 160mg | Drug | Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia. |
|
| 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 |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D007659 | Ketones |