Metformin as Added on Therapy in Patients With Ulcerative Colitis
Phase 2 · Testing Metformin · 1 site · Tanta University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Metformin (a drug) as a possible treatment. Condition(s) listed: Inflammatory Bowel Diseases.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- \- 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
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 46 participants are expected to take part.
- Start date: 2023-01-20.
- Main results expected around 2026-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Egypt.
Main thing being measured
- Improvement in HRQL through changes in inflammatory bowel disease questionnaire (IBDQ) score and change in mayo scores (6 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | Tanta University |
| Collaborators | Principal Investigator Mostafa Mahmoud Bahaa El-Dien Pharmacy Practice Department- Horus University |
| Enrollment | 46 (estimated) |
| Start date | 2023-01-20 |
| Primary completion (est.) | 2026-12 |
| First posted | 2022-10-10 |
| Last updated | 2025-03-04 |
| Official title | Metformin, The Biguanide Derivative, as Adjuvant Therapy in Patients With Ulcerative Colitis Treated With Mesalamine |
| ClinicalTrials.gov ID | NCT05574387 |
Interventions
- Metformin (Drug)
Metformin is an antidiabetic biguanide drug that acts by promoting glucose uptake and utilization in the liver.Recent studies proved that metformin could reduce colonic inflammation by AMPK-mediated inhibition of p38 mitogen-activated protein kinase (MAPK)
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine, Mansoura University | Al Mansurah | Egypt | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.