Back to resultsActivation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease
Primary Purpose
Inflammatory Bowel Diseases
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Mesalamine
Dapagliflozin 10mg Tab
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
control group
Dapagliflozin group
Arm Description
Control group ( Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months
Patients will receive 1 g mesalamine three times daily plus dapagliflozin 10 mg once daily for 6 months
Outcomes
Primary Outcome Measures
The primary endpoint is the change in mayo score
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05986136
Brief Title
Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease
Official Title
Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2023 (Actual)
Primary Completion Date
August 20, 2024 (Anticipated)
Study Completion Date
July 20, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mostafa Bahaa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double-blinded
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Control group ( Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months
Arm Title
Dapagliflozin group
Arm Type
Active Comparator
Arm Description
Patients will receive 1 g mesalamine three times daily plus dapagliflozin 10 mg once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10mg Tab
Intervention Description
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
Primary Outcome Measure Information:
Title
The primary endpoint is the change in mayo score
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Bahaa, PhD
Phone
0201025538337
Email
mbahaa@horus.edu.eg
Facility Information:
Facility Name
Faculty of Medicine, Mansoura University
City
Mansoura
ZIP/Postal Code
7650001
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa Bahaa, PhD
Phone
0201025538337
Email
mbahaa@horus.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease
We'll reach out to this number within 24 hrs