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

Phase 2

Recruiting

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Mesalamine; Drug: Dapagliflozin 10mg Tab

• Registration Number: NCT05986136
• Lead Sponsor: Mostafa Bahaa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-14
• Study Start: 2023-08-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-08-20
• Study Completion: 2028-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin group	Dapagliflozin 10mg Tab	Patients will receive 1 g mesalamine three times daily plus dapagliflozin 10 mg once daily for 6 months
control group	Mesalamine	Control group ( Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months
Dapagliflozin group	Mesalamine	Patients will receive 1 g mesalamine three times daily plus dapagliflozin 10 mg once daily for 6 months

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine, Mansoura University; 🇪🇬 Mansoura, Egypt