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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMostafa Bahaa

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Both male and female will be

Mild and moderate UC patients diagnosed and confirmed by endoscope

Disqualifiers

Breast feeding

Significant liver and kidney function abnormalities

Colorectal cancer patients

Patients with severe UC

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mesalamine

    Drug

    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

  • Dapagliflozin 10mg Tab

    Drug

    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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: control groupActive comparator 1 intervention
Group B: Dapagliflozin groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mostafa Bahaa

Lead sponsor

Tanta University

Sponsor institution