Inflammatory Bowel Diseases
Conditions
Brief summary
The inflammatory bowel diseases (IBD) are described as complex, recurrent inflammatory conditions which are manifested as Crohn's disease (CD) and ulcerative colitis (UC). The common symptoms of IBD include debilitating/severe diarrhea, abdominal pain, weight loss, and chronic fatigue; events that may culminate in life-threatening complications. The pathogenesis of IBD has been characterized as complex/multi-factorial that includes disruption of intestinal epithelial barrier with consequent translocation of commensal microbial products as the prime event that instigates severe immune responses and intestinal inflammation.
Interventions
DRUGMesalamine
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
DRUGDapagliflozin 10mg Tab
Dapagliflozin has emerged as a selective SGLT2 inhibitor for the management of type-2 diabetes mellitus with minimal risk of hypoglycemia and it exerts diuretic-like actions and lowering of blood pressure, thereby, reducing the risk of hospitalization in type-2 diabetic patients with co-existing heart failure
Sponsors
Mostafa Bahaa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blinded
Eligibility
Sex/Gender
ALL
Age
18 Months to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Both male and female will be * Mild and moderate UC patients diagnosed and confirmed by endoscope
Exclusion criteria
* Breast feeding * Significant liver and kidney function abnormalities * Colorectal cancer patients * Patients with severe UC * Patients taking rectal or systemic steroids * Patients taking immunosuppressives or biological therapies * Addiction to alcohol and / or drugs * Known allergy to the dapagliflozin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is the change in mayo score | 6 months | The Mayo score is one of the most commonly used disease activity indices in placebo-controlled trials in UC. In its complete form, it is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance |
Countries
Egypt
Contacts
CONTACTMostafa Bahaa, PhD
Outcome results
None listed