Ulcerative ColitisPhase 2NCT04750135
Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis
A Phase 2 study testing metformin 500 mg TID Oral Tablet in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
Trial summary
Brief Summary: This is a randomized, controlled study evaluating metformin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of metformin in the treatment of mild to moderately active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- metformin 500 mg TID Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Feb 2021to 1 Jun 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
- Adults (males and/or females) with age range from 18 to 65 years old.
- Patients on treatment with 5-aminosalisylic acid (5-ASA)
Who cannot join
- Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
- Treatment with systemic or rectal steroids.
- Treatment with immunosuppressants.
- Previously failed treatment with a sulphasalazine.
- Known hypersensitivity to any of study drugs.
- Hepatic and renal dysfunction.
Show all 14Show fewer
- Pregnancy and lactation.
- History of colorectal carcinoma.
- History of complete or partial colectomy.
- Current or previous treatment with metformin for females with polycystic ovarian syndrome.
- Patients with diabetes mellitus
- Patients with history of lactic acidosis
- Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
- Positive stool culture for enteric pathogens, positive stool ova and parasite exam.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tanta University Hospitals
Tanta, Gharbia Governorate
Nahla Khalaf, MD
MD
About this study
Brief Summary:
This is a randomized, controlled study evaluating metformin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of metformin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Being tested
- metformin 500 mg TID Oral Tablet, Placebo
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin 500 mg TID Oral TabletDrug
Also called Glucophage XR
biguanides derivatives
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | participants will receive placebo for 8 consecutive weeks in addition to the standard therapy Receives: Drug: Placebo |
| Metformin group | Experimental | participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy Receives: Drug: metformin 500 mg TID Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the two groups in the expression of colonic (NF)-κB proteins.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start7 Feb 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Hepatology & Tropical Medicine Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Doaa abdelaziz, National Hepatology & Tropical Medicine Research Institute
- Investigators
- Noha Mansour, PhD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750135
- Sponsor's protocol ID
- 21-2019
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hegazy SK, El-Bedewy MM. Effect of probiotics on pro-inflammatory cytokines and NF-kappaB activation in ulcerative colitis. World J Gastroenterol. 2010 Sep 7;16(33):4145-51. doi: 10.3748/wjg.v16.i33.4145.
PubMed 20806430Lewis JD, Lichtenstein GR, Deren JJ, Sands BE, Hanauer SB, Katz JA, Lashner B, Present DH, Chuai S, Ellenberg JH, Nessel L, Wu GD; Rosiglitazone for Ulcerative Colitis Study Group. Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial. Gastroenterology. 2008 Mar;134(3):688-95. doi: 10.1053/j.gastro.2007.12.012. Epub 2007 Dec 7.
PubMed 18325386Samman FS, Elaidy SM, Essawy SS, Hassan MS. New insights on the modulatory roles of metformin or alpha-lipoic acid versus their combination in dextran sulfate sodium-induced chronic colitis in rats. Pharmacol Rep. 2018 Jun;70(3):488-496. doi: 10.1016/j.pharep.2017.11.015. Epub 2017 Nov 24.
PubMed 29653414
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04750135
- Acronym / sponsor ID
- 21-2019
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Hepatology & Tropical Medicine Research InstituteOther government
- Study start
- 7 Feb 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 11 Feb 2021 (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.
Brief Summary:
This is a randomized, controlled study evaluating metformin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of metformin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Placeboparticipants will receive placebo for 8 consecutive weeks in addition to the standard therapy |
| Metformin group | Experimental | Drug: metformin 500 mg TID Oral Tabletparticipants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
- Adults (males and/or females) with age range from 18 to 65 years old.
- Patients on treatment with 5-aminosalisylic acid (5-ASA)
Key exclusion criteria (14 listed)
- Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
- Treatment with systemic or rectal steroids.
- Treatment with immunosuppressants.
- Previously failed treatment with a sulphasalazine.
- Known hypersensitivity to any of study drugs.
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 |
|---|---|---|
| metformin 500 mg TID Oral TabletAlso: Glucophage XRbiguanides derivatives | Drug | Metformin group |
| PlaceboPlacebo | Drug | Control group |
Primary outcome
Difference between the two groups in the expression of colonic (NF)-κB proteins.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Background: PubMed 20806430Hegazy SK, El-Bedewy MM. Effect of probiotics on pro-inflammatory cytokines and NF-kappaB activation in ulcerative colitis. World J Gastroenterol. 2010 Sep 7;16(33):4145-51. doi: 10.3748/wjg.v16.i33.4145.
- Background: PubMed 18325386Lewis JD, Lichtenstein GR, Deren JJ, Sands BE, Hanauer SB, Katz JA, Lashner B, Present DH, Chuai S, Ellenberg JH, Nessel L, Wu GD; Rosiglitazone for Ulcerative Colitis Study Group. Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial. Gastroenterology. 2008 Mar;134(3):688-95. doi: 10.1053/j.gastro.2007.12.012. Epub 2007 Dec 7.
- Background: PubMed 29653414Samman FS, Elaidy SM, Essawy SS, Hassan MS. New insights on the modulatory roles of metformin or alpha-lipoic acid versus their combination in dextran sulfate sodium-induced chronic colitis in rats. Pharmacol Rep. 2018 Jun;70(3):488-496. doi: 10.1016/j.pharep.2017.11.015. Epub 2017 Nov 24.
- Individual participant dataSharing planned: Undecided
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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.
Noha Mansour, PhD principal investigator
Mansoura University
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 500 mg TID Oral Tablet in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by National Hepatology & Tropical Medicine Research Institute 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 14 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: status not confirmed, as of the sponsor's last update on 11 Feb 2021. 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?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa Hamed, PhD (+202 23642494, Abdelaziz.h.doaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the two groups in the expression of colonic (NF)-κB proteins. (time frame: 8 weeks). 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 NCT04750135, which also lists 3 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 11 Feb 2021.