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This study aimed to evaluate the role of microbiota and probiotics in Egyptian patients with ulcerative colitis.
Inflammatory bowel disease (IBD) is a group of chronic diseases that significantly affects patients' quality of life and is mainly represented by Crohn's disease (CD) and ulcerative colitis (UC).
The microbiome is a key contributor to various fundamental aspects of human health, including host metabolism, infection, and the immune response.
Changes in microbiome composition have been linked to complex multifactorial diseases, e.g., type 2 diabetes, metabolic syndrome, and non-alcoholic fatty liver syndrome, as well as inflammatory bowel disease (IBD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Patients with ulcerative colitis in remission treated with oral mesalamine. |
| |
| Group II | Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii). |
| |
| Group III | Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii). |
| |
| Group IV | Apparent healthy controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesalamine | Drug | Patients with ulcerative colitis in remission treated with oral mesalamine. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Activity Index | The clinical activity index (CAI) is a tool that assesses disease activity in patients with ulcerative colitis. Seven clinical features are evaluated, with the total index score ranging from 0 to 25: 0 to 4 inactive (remission); 5 to 10 mild activity; 11 to 17 moderate activity; and ≥ 18 high activity. CAI was measured at the study start and every 3 months through the follow up period (1year) | 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Body mass index (BMI) was measured at the study start and every 3 months during the study follow-up period | 12 months post-procedure |
| Gut Microbiota | Gut Microbiota was measured. |
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Inclusion Criteria:
Exclusion Criteria:
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This study is a prospective study that will be carried in Tanta University Hospital, Tropical Medicine and Infectious Diseases Department.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Probiotics (Bacillus Clausii) |
| Drug |
Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii). |
|
| Mesalamine and probiotics (Bacillus Clausii) | Drug | Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii). |
|
| 12 months post-procedure |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| 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 |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |