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AzTrials

Ulcerative ColitisEarly Phase 1NCT05610956

Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis

A Early Phase 1 study testing Empagliflozin and conventional treatment in people with Ulcerative Colitis, run by Tanta University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

•This study will be a randomized, controlled, parallel study. .To demonstrate the efficacy of empagliflozin and clinical improvement in patients of mild to moderate UC using the Montreal classification of severity of ulcerative colitis. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Empagliflozin and conventional treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Jan 2023to 1 Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • •Patients with mild to moderate UC are diagnosed by history, clinical signs according to the Montreal classification of severity of ulcerative colitis and( Endoscopy, and biopsy) to establish the chronicity of inflammation and to exclude other causes of colitis.

Who cannot join

  • Other inflammatory bowel diseases (CD).
  • History of serious hypersensitivity to empagliflozin or any component of the formulation.
  • Patients on dialysis.
  • Severe renal impairment (eGFR <20 ml/minute/1.73m2) .
  • Chronic urinary tract infection.
  • Chronic genital infection.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

youmna H eldeeb, phD contact

01014860930

youmnahamdyeldeeb@gmail.com

Sahar M Elhaggar contact

01008838807

Egypt1 site, 1 recruiting

  • Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital.

    Tanta

    Mohamed El Sarhan, Lecturer, +20 100 193 0950

    Recruiting

Other trials in Egypt

About this study

Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis

•This study will be a randomized, controlled, parallel study. .To demonstrate the efficacy of empagliflozin and clinical improvement in patients of mild to moderate UC using the Montreal classification of severity of ulcerative colitis.

Read the detailed description
  • It will be conducted on 60 patients having with mild to moderate degree UC divided into two groups:
  1. Group 1 (n=30): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid).
  2. Group 2 (n=30): Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day).
  • The patient will be selected from the Gastroenterology and Endoscopy Unit, Internal Medicine. . All patients will be subjected to the following:
  • Complete history taking.
  • Colonoscopy with intubation of the ileum and biopsies of affected and unaffected areas should be obtained to confirm the diagnosis of UC.
  • Blood sample collection to assess:
  1. Routine Laboratory tests
  2. Complete blood picture (CBC).
  3. Liver functions (ALT, AST, Total and Direct Bilirubin).
  4. Kidney functions tests (Urea, serum creatinine).
  5. C-reactive protein.
  6. Fasting blood glucose.
  7. Urine analysis. B) Specific Laboratory tests
  8. Tumor necrosis factor alpha (TNF-α). 2. Adenosine monophosphate activate protein kinase (AMPK). 3. Fecal calprotectin. All patients will be assessed at baseline and after 4 months of therapy for all parameters
Being tested
Empagliflozin, conventional treatment
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpagliflozinDrug

    Patients will receive empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)and conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months.

  • conventional treatmentDrug

    conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months

Study groups in NCT05610956
Study groupRoleWhat they receive
placebo groupPlacebo comparatorPatients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 4 months.
Receives: Drug: conventional treatment
empagliflozin groupExperimentalPatients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)for 4months.
Receives: Drug: Empagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis.

    difference between the two groups in (number of stool per day+prescence of fever +present of systemic toxicity+hemoglibin +ESR)

    Measured: 4months

Secondary outcomes (3)

  1. expression of TNFalpha

    difference between the two groups in TNFalpha

    Measured: 4months

  2. expression of Adenosine monophosphate activated protein kinase (AMPK ).

    difference between the two groups in Adenosine monophosphate activated protein kinase (AMPK )

    Measured: 4months

  3. expression of Fecal calprotectin

    difference between the two groups in fecal calprotectin

    Measured: 4months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2022
  2. Study start1 Jan 2023
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
parallel randomized controlled
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05610956
Sponsor's protocol ID
empagliflozin in UC
Status last verified
Jul 2025
First submitted
31 Oct 2022
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Karle EJ, Gehring F, Trautner K. [Cariogenic properties of various snacks in animal experiments]. Dtsch Zahnarztl Z. 1977 Sep;32(9):741-3. German.

    PubMed 269076

  • Rubin DT, Huo D, Kinnucan JA, Sedrak MS, McCullom NE, Bunnag AP, Raun-Royer EP, Cohen RD, Hanauer SB, Hart J, Turner JR. Inflammation is an independent risk factor for colonic neoplasia in patients with ulcerative colitis: a case-control study. Clin Gastroenterol Hepatol. 2013 Dec;11(12):1601-8.e1-4. doi: 10.1016/j.cgh.2013.06.023. Epub 2013 Jul 17.

    PubMed 23872237

  • Gasche C, Scholmerich J, Brynskov J, D'Haens G, Hanauer SB, Irvine EJ, Jewell DP, Rachmilewitz D, Sachar DB, Sandborn WJ, Sutherland LR. A simple classification of Crohn's disease: report of the Working Party for the World Congresses of Gastroenterology, Vienna 1998. Inflamm Bowel Dis. 2000 Feb;6(1):8-15. doi: 10.1097/00054725-200002000-00002.

    PubMed 10701144

  • Colman RJ, Rubin DT. Histological inflammation increases the risk of colorectal neoplasia in ulcerative colitis: a systematic review. Intest Res. 2016 Jul;14(3):202-10. doi: 10.5217/ir.2016.14.3.202. Epub 2016 Jun 27.

    PubMed 27433141

  • Esmat S, El Nady M, Elfekki M, Elsherif Y, Naga M. Epidemiological and clinical characteristics of inflammatory bowel diseases in Cairo, Egypt. World J Gastroenterol. 2014 Jan 21;20(3):814-21. doi: 10.3748/wjg.v20.i3.814.

    PubMed 24574754

  • Jess T, Frisch M, Simonsen J. Trends in overall and cause-specific mortality among patients with inflammatory bowel disease from 1982 to 2010. Clin Gastroenterol Hepatol. 2013 Jan;11(1):43-8. doi: 10.1016/j.cgh.2012.09.026. Epub 2012 Sep 27.

    PubMed 23022699

  • Regueiro M, Greer JB, Szigethy E. Etiology and Treatment of Pain and Psychosocial Issues in Patients With Inflammatory Bowel Diseases. Gastroenterology. 2017 Feb;152(2):430-439.e4. doi: 10.1053/j.gastro.2016.10.036. Epub 2016 Nov 2.

    PubMed 27816599

  • MacDermott RP, Sanderson IR, Reinecker HC. The central role of chemokines (chemotactic cytokines) in the immunopathogenesis of ulcerative colitis and Crohn's disease. Inflamm Bowel Dis. 1998 Feb;4(1):54-67. doi: 10.1097/00054725-199802000-00009.

    PubMed 9552229

  • Greenstein AJ, Sachar DB, Gibas A, Schrag D, Heimann T, Janowitz HD, Aufses AH Jr. Outcome of toxic dilatation in ulcerative and Crohn's colitis. J Clin Gastroenterol. 1985 Apr;7(2):137-43. doi: 10.1097/00004836-198504000-00007.

    PubMed 4008909

  • Jalan KN, Sircus W, Card WI, Falconer CW, Bruce CB, Crean GP, McManus JP, Small WP, Smith AN. An experience of ulcerative colitis. I. Toxic dilation in 55 cases. Gastroenterology. 1969 Jul;57(1):68-82. No abstract available.

    PubMed 5305933

  • Bedine MS. Textbook of gastroenterology. Gastroenterology. 2000 May;118(5):984-5. doi: 10.1016/s0016-5085(00)70191-0. No abstract available.

    PubMed 10784603

  • Bernstein CN, Wajda A, Blanchard JF. The incidence of arterial thromboembolic diseases in inflammatory bowel disease: a population-based study. Clin Gastroenterol Hepatol. 2008 Jan;6(1):41-5. doi: 10.1016/j.cgh.2007.09.016. Epub 2007 Dec 11.

    PubMed 18063423

  • Merigo F, Brandolese A, Facchin S, Missaggia S, Bernardi P, Boschi F, D'Inca R, Savarino EV, Sbarbati A, Sturniolo GC. Glucose transporter expression in the human colon. World J Gastroenterol. 2018 Feb 21;24(7):775-793. doi: 10.3748/wjg.v24.i7.775.

    PubMed 29467549

  • Zhou H, Wang S, Zhu P, Hu S, Chen Y, Ren J. Empagliflozin rescues diabetic myocardial microvascular injury via AMPK-mediated inhibition of mitochondrial fission. Redox Biol. 2018 May;15:335-346. doi: 10.1016/j.redox.2017.12.019. Epub 2017 Dec 30.

    PubMed 29306791

  • Iannantuoni F, M de Maranon A, Diaz-Morales N, Falcon R, Banuls C, Abad-Jimenez Z, Victor VM, Hernandez-Mijares A, Rovira-Llopis S. The SGLT2 Inhibitor Empagliflozin Ameliorates the Inflammatory Profile in Type 2 Diabetic Patients and Promotes an Antioxidant Response in Leukocytes. J Clin Med. 2019 Nov 1;8(11):1814. doi: 10.3390/jcm8111814.

    PubMed 31683785

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Empagliflozin and conventional treatment in people with Ulcerative Colitis, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact youmna H eldeeb, phD (01014860930, youmnahamdyeldeeb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis. (time frame: 4months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05610956, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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