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

Mostafa Bahaa

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Dapagliflozin 10mg Tab; Drug: Mesalamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05986136

Tanta 1234

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 months to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

control group

Active Comparator group

Description:

Control group ( Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months

Treatment:

Drug: Mesalamine

Dapagliflozin group

Active Comparator group

Description:

Patients will receive 1 g mesalamine three times daily plus dapagliflozin 10 mg once daily for 6 months

Treatment:

Drug: Mesalamine

Drug: Dapagliflozin 10mg Tab