Actively Recruiting

Phase 2
Phase 3
Age: 18Months - 60Years
All Genders
ID05986136

Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease A Randomized Controlled Trial Comparing Dapagliflozin Plus Mesalamine Versus Mesalamine Alone

Led by Mostafa Bahaa · Updated on 2026-03-13

50

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying inflammatory bowel diseases (IBD), which include Crohn's disease and ulcerative colitis (UC). These complex, recurring conditions cause symptoms like severe diarrhea, abdominal pain, weight loss, and fatigue, sometimes leading to serious complications. The study aims to evaluate the effects of dapagliflozin combined with mesalamine on IBD by focusing on how activating autophagy and suppressing cell death may reduce disease activity. Participants will be randomly assigned to one of two groups for six months. One group will receive mesalamine alone, taken as 1 gram three times daily. The other group will take the same mesalamine dose plus dapagliflozin 10 mg once daily. Both treatments are drugs being studied to assess their impact on IBD symptoms and inflammation. During the study, researchers will monitor participants over six months, measuring changes in the Mayo score, a tool used to assess UC severity. Participants will have regular evaluations to track symptoms and disease progression. The study is double-blinded, meaning neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. This trial is designed for adults aged 18 to 60 with mild to moderate ulcerative colitis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Months - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Male and female participants are eligible
  • Diagnosed with mild or moderate ulcerative colitis confirmed by endoscopy
Not Eligible

You will not qualify if you...

  • Currently breastfeeding
  • Significant liver or kidney function abnormalities
  • Diagnosis of colorectal cancer
  • Severe ulcerative colitis
  • Use of rectal or systemic steroids
  • Use of immunosuppressive or biological therapies
  • Addiction to alcohol or drugs
  • Known allergy to dapagliflozin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 6 months

Participants receive mesalamine alone or mesalamine combined with dapagliflozin daily to treat ulcerative colitis.

Regular visits for treatment monitoring

Trial Site Locations

Total: 1 location

1

Faculty of Medicine, Mansoura University

Al Mansurah, Egypt, 7650001

Actively Recruiting

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Research Team

M

Mostafa Bahaa, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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