Inflammatory Bowel DiseasesPhase 2NCT05553704
Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
A Phase 2 study testing Metformin in people with Inflammatory Bowel Diseases, run by Tanta University at 1 site in Egypt.
Trial summary
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Both males and females will be included
- Negative pregnancy test and effective contraception
Who cannot join
- •
- Breast feeding
- Significant liver and kidney function abnormalities
- Diabetic patients
- Colorectal cancer patients
- Patients with severe UC
Show all 10Show fewer
- Patients taking rectal or systemic steroids
- Patients taking immunosuppressives or biological therapies
- Addiction to alcohol and / or drugs
- Known allergy to the studied medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Metformin
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | this group will take mesalamine 1 gm three times daily for 6 months |
| metformin group | Active comparator | this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change in partial mayo score index
The Partial Mayo Score index is a non-invasive clinical scale used to assess the severity of ulcerative colitis. It is a composite of sub scores from three categories, including stool frequency, rectal bleeding, and physician's global assessment, with a total score ranging from 0-9
Measured: 6 months
Secondary outcomes (1)
The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha
The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Nov 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Mounir Hussein Bahgat Internal Medicine Department Mansoura University, Maha Mohamed Maher Internal Medicine Department Mansoura University
- Responsible party
- Principal investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553704
- Sponsor's protocol ID
- 3422
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Binsaleh AY, El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Elmasry TA, Alrubia S, Alsegiani AS, Eldesoqui M, Bahaa MM. The adjunctive role of metformin in patients with mild to moderate ulcerative colitis: a randomized controlled study. Front Pharmacol. 2025 Mar 19;16:1507009. doi: 10.3389/fphar.2025.1507009. eCollection 2025.
PubMed 40191419El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Bahaa MM. Repurposing metformin as adjuvant therapy in patients with ulcerative colitis treated with mesalamine: A randomized controlled double-blinded study. Int Immunopharmacol. 2024 Sep 10;138:112541. doi: 10.1016/j.intimp.2024.112541. Epub 2024 Jun 24.
PubMed 38917525
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
- ClinicalTrials.gov ID
- NCT05553704
- Acronym / sponsor ID
- 3422
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Mounir Hussein Bahgat Internal Medicine Department Mansoura University, Maha Mohamed Maher Internal Medicine Department Mansoura University
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –this group will take mesalamine 1 gm three times daily for 6 months |
| metformin group | Active comparator | Drug: Metforminthis group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Both males and females will be included
- Negative pregnancy test and effective contraception
Key exclusion criteria (10 listed)
- •
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metforminmetformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily | Drug | metformin group |
Primary outcome
The primary endpoint is the change in partial mayo score index
Time frame: 6 months
The Partial Mayo Score index is a non-invasive clinical scale used to assess the severity of ulcerative colitis. It is a composite of sub scores from three categories, including stool frequency, rectal bleeding, and physician's global assessment, with a total score ranging from 0-9
1 secondary outcome
The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 40191419Binsaleh AY, El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Elmasry TA, Alrubia S, Alsegiani AS, Eldesoqui M, Bahaa MM. The adjunctive role of metformin in patients with mild to moderate ulcerative colitis: a randomized controlled study. Front Pharmacol. 2025 Mar 19;16:1507009. doi: 10.3389/fphar.2025.1507009. eCollection 2025.
- Derived from this study: PubMed 38917525El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Bahaa MM. Repurposing metformin as adjuvant therapy in patients with ulcerative colitis treated with mesalamine: A randomized controlled double-blinded study. Int Immunopharmacol. 2024 Sep 10;138:112541. doi: 10.1016/j.intimp.2024.112541. Epub 2024 Jun 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Inflammatory Bowel Diseases, 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 30 Oct 2026. 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. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the change in partial mayo score index (time frame: 6 months). 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 NCT05553704, which also lists 2 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 30 Oct 2026.