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Recruiting Phase 2 NCT05574387

NCT05574387 Metformin as Added on Therapy in Patients With Ulcerative Colitis

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Clinical Trial Summary
NCT ID NCT05574387
Status Recruiting
Phase Phase 2
Sponsor Tanta University
Condition Inflammatory Bowel Diseases
Study Type INTERVENTIONAL
Enrollment 46 participants
Start Date 2023-01-20
Primary Completion 2026-12

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 75 Years
Study Type INTERVENTIONAL
Interventions
Metformin

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 46 participants in total. It began in 2023-01-20 with a primary completion date of 2026-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is marked by increased intestinal motility and bloody diarrhea. The clinical value of existing therapeutic strategies of UC, including glucocorticoids, anti-tumor necrosis factor α (TNF-α), mesalamine, and thiopurines is still limited. Therefore, the discovery of new therapeutic approaches is essential to improve the effectiveness of the treatment.Adenosine monophosphate (AMP)-activated protein kinase (AMPK) is a conserved fuel-sensing enzyme that plays an important role in the regulation of cellular metabolism where it increases glucose and fatty acids uptake and activates the oxidation process to improve the cellular energy utilization

Eligibility Criteria

Inclusion Criteria: \- Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception Mild and moderate UC patients diagnosed and confirmed by the endoscope Exclusion Criteria: \- Breastfeeding Significant liver and kidney function abnormalities Diabetic patients Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids

Contact & Investigator

Central Contact

Mostafa Bahaa, PhD

✉ mbahaa@horus.edu.eg

📞 0201025538337

Frequently Asked Questions

Who can join the NCT05574387 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT05574387 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT05574387 currently recruiting?

Yes, NCT05574387 is actively recruiting participants. Contact the research team at mbahaa@horus.edu.eg for enrollment information.

Where is the NCT05574387 trial being conducted?

This trial is being conducted at Al Mansurah, Egypt.

Who is sponsoring the NCT05574387 clinical trial?

NCT05574387 is sponsored by Tanta University. The trial plans to enroll 46 participants.

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