RecruitingPhase 2Phase 3NCT05986136

Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease


Sponsor

Mostafa Bahaa

Enrollment

50 participants

Start Date

Aug 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 MonthsMax Age: 60 Years

Inclusion Criteria3

  • Age ≥ 18 years
  • Both male and female will be
  • Mild and moderate UC patients diagnosed and confirmed by endoscope

Exclusion Criteria8

  • 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

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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


Locations(1)

Faculty of Medicine, Mansoura University

Al Mansurah, Egypt

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NCT05986136


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