Inflammatory Bowel DiseasesPhase 2NCT06201793
Minocyclin in Ulcerative Colitis as Added on Therapy
A Phase 2 study testing Mesalazine and Minocycline in people with Inflammatory Bowel Diseases, run by Mostafa Bahaa at 1 site in Egypt.
Trial summary
Ulcerative colitis (UC) is considered a subcategory of inflammatory bowel disease and the exact cause of ulcerative colitis remains undetermined. the condition appears to be related dysregulated immune response and consequent activation of inflammatory cascades, which are often affected by genetic susceptibility and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Mesalazine and Minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2024to 20 Jan 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years old Both male and female will be included Mild and moderate UC patients diagnosed and confirmed by endoscope Patient treated with 5-aminosalislic acid (mesalamine)
Who cannot join
- Patients with severe UC Pregnancy and lactating females Significant liver and kidney function abnormalities Diabetic patients Patients with Colorectal cancer patients Patients taking rectal or systemic steroids Patients on immunosuppressants or biological therapies Patients taking antacids, anticoagulants, bactericidal antibiotics, oral contraceptives, and isotretinoin.
- Addiction to alcohol and / or drugs Known allergy to the studied medications History of complete or partial colectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of Minocycline in Patients With Ulcerative Colitis Treated With Mesalamine
Ulcerative colitis (UC) is considered a subcategory of inflammatory bowel disease and the exact cause of ulcerative colitis remains undetermined. the condition appears to be related dysregulated immune response and consequent activation of inflammatory cascades, which are often affected by genetic susceptibility and environmental factors, and 20% to 40% of patients with UC also exhibit extraintestinal manifestations involving the joints, skin, eyes, or hepatobiliary tract
Read the detailed description
Most conventional UC therapies rely primarily on downregulating aberrant immune responses and inflammatory cascades. Mesalamine and corticosteroids are the mainstays in management of UC. However, 20% to 32% of UC patients do not respond to steroid.4 Some antibiotics offer protection against experimental and clinical colitis.
Mesalazine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management. It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC. The mechanism of action of mesalazine is diverse. It acts locally on colonic mucosa and reduce inflammation by several anti-inflammatory processes. It has a potent antioxidant and free-radical scavenger properties.
Nitrosative stress caused by inducible nitric oxide synthase (iNOS)-derived nitric oxide (NO) production and matrix metalloproteinases (MMPs) have been shown to play an important role in the pathogenesis of UC. As in human UC, expression of MMPs and iNOS are also implicated in the pathogenesis of experimental colitis, Therefore, it is important to develop and evaluate agents that have low-severity adverse effects that can treat UC by blocking inflammatory responses involved in nitrosative stress and/or MMP activation.
Minocycline, a semisynthetic tetracycline, is a safe, widely used and inexpensive antibiotic with a broad spectrum.
Several recent studies have demonstrated that, in addition to its antimicrobial effects, minocycline exerts anti-inflammatory, antiangiogenic, and antiapoptotic effects. These biological effects of minocycline have been shown to have a therapeutic or preventive effect in neurodegenerative disease, neural ischemic damage, ischemic renal injury, rheumatoid arthritis, acne vulgaris, pyoderma gangrenosum, and periodontitis. The mechanisms by which minocycline alleviates these illnesses involve suppressing expression and/or activity of iNOS, MMPs, TNF-α and caspases, and blocking cytochrome-c release. Several animal models of intestinal inflammation have been established, although some only partially resemble human UC.
Also, minocycline improved the colonic oxidative status and decreased the expression of different chemotactic mediators like expressions of the chemokine's monocyte chemotactic protein-1 (MCP-1) and cytokine-induced neutrophil chemoattractant-1 (CINC-1) as well as of the intercellular adhesion molecule-1 (ICAM-1) in the inflamed tissue. However, the in vitro experiments performed revealed that minocycline reduced the release of the chemokine IL-8 by the intestinal epithelial cells Caco-2.
The immunological activity of minocycline was reinforced by its remarkable effect in restoring a balanced intestinal microbiota. the preclinical study shows that the counts of lactobacilli and bifidobacteria, which were downregulated in colitic rats from control group when compared with healthy rats, only appeared increased after treatment with minocycline.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Mesalazine, Minocycline
- 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.
MesalazineDrug
Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis
MinocyclineDrug
Minocycline is a tetracycline antibiotic medication used to treat a number of bacterial infections such as pneumonia. It is generally less preferred than the tetracycline doxycycline. Minocycline is also used for the treatment of acne and rheumatoid arthritis.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months. Receives: Drug: Mesalazine |
| Minocycline group | Active comparator | minocycline group, n = 23) will receive 1 g mesalamine three times daily plus 100 mg minocycline orally twice daily for 6 months. Receives: Drug: Mesalazine; Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of disease activity using Partial Mayo Scoring Index
Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity. It depends on three items; stool frequency, rectal bleeding (blood in stool) and Physician's Global Assessment. Each item has a score from 0 to 3 and total PMSI is the sum of scores for the three items.
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 posted11 Jan 2024
- Study start22 Jan 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mostafa Bahaa
- Sponsor type
- University, hospital or other
- Collaborators
- Horus University, Tanta University, Mounir Hussein Bahgat Internal Medicine Department Mansoura University
- Responsible party
- Sponsor-investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201793
- Sponsor's protocol ID
- 236977
- Status last verified
- Nov 2025
- First submitted
- 31 Dec 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mashaly AF, Hegazy SK, Bahgat MM. Repurposing minocycline as an added-on treatment for ulcerative colitis patients on mesalamine: a randomized clinical pilot study. Naunyn Schmiedebergs Arch Pharmacol. 2026 Feb;399(3):4555-4568. doi: 10.1007/s00210-025-04662-2. Epub 2025 Oct 23.
PubMed 41128897
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Efficacy and Safety of Minocycline in Patients With Ulcerative Colitis Treated With Mesalamine
- ClinicalTrials.gov ID
- NCT06201793
- Acronym / sponsor ID
- 236977
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Mostafa BahaaUniversity, hospital or other
- Collaborators
- Horus University, Tanta University, Mounir Hussein Bahgat Internal Medicine Department Mansoura University
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 11 Jan 2024 (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 considered a subcategory of inflammatory bowel disease and the exact cause of ulcerative colitis remains undetermined. the condition appears to be related dysregulated immune response and consequent activation of inflammatory cascades, which are often affected by genetic susceptibility and environmental factors, and 20% to 40% of patients with UC also exhibit extraintestinal manifestations involving the joints, skin, eyes, or hepatobiliary tract
Detailed description
Most conventional UC therapies rely primarily on downregulating aberrant immune responses and inflammatory cascades. Mesalamine and corticosteroids are the mainstays in management of UC. However, 20% to 32% of UC patients do not respond to steroid.4 Some antibiotics offer protection against experimental and clinical colitis.
Mesalazine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management. It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC. The mechanism of action of mesalazine is diverse. It acts locally on colonic mucosa and reduce inflammation by several anti-inflammatory processes. It has a potent antioxidant and free-radical scavenger properties.
Nitrosative stress caused by inducible nitric oxide synthase (iNOS)-derived nitric oxide (NO) production and matrix metalloproteinases (MMPs) have been shown to play an important role in the pathogenesis of UC. As in human UC, expression of MMPs and iNOS are also implicated in the pathogenesis of experimental colitis, Therefore, it is important to develop and evaluate agents that have low-severity adverse effects that can treat UC by blocking inflammatory responses involved in nitrosative stress and/or MMP activation.
Minocycline, a semisynthetic tetracycline, is a safe, widely used and inexpensive antibiotic with a broad spectrum.
Several recent studies have demonstrated that, in addition to its antimicrobial effects, minocycline exerts anti-inflammatory, antiangiogenic, and antiapoptotic effects. These biological effects of minocycline have been shown to have a therapeutic or preventive effect in neurodegenerative disease, neural ischemic damage, ischemic renal injury, rheumatoid arthritis, acne vulgaris, pyoderma gangrenosum, and periodontitis. The mechanisms by which minocycline alleviates these illnesses involve suppressing expression and/or activity of iNOS, MMPs, TNF-α and caspases, and blocking cytochrome-c release. Several animal models of intestinal inflammation have been established, although some only partially resemble human UC.
Also, minocycline improved the colonic oxidative status and decreased the expression of different chemotactic mediators like expressions of the chemokine's monocyte chemotactic protein-1 (MCP-1) and cytokine-induced neutrophil chemoattractant-1 (CINC-1) as well as of the intercellular adhesion molecule-1 (ICAM-1) in the inflamed tissue. However, the in vitro experiments performed revealed that minocycline reduced the release of the chemokine IL-8 by the intestinal epithelial cells Caco-2.
The immunological activity of minocycline was reinforced by its remarkable effect in restoring a balanced intestinal microbiota. the preclinical study shows that the counts of lactobacilli and bifidobacteria, which were downregulated in colitic rats from control group when compared with healthy rats, only appeared increased after treatment with minocycline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Mesalazinecontrol group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months. |
| Minocycline group | Active comparator | Drug: Mesalazine, Drug: Minocyclineminocycline group, n = 23) will receive 1 g mesalamine three times daily plus 100 mg minocycline orally twice daily for 6 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years old Both male and female will be included Mild and moderate UC patients diagnosed and confirmed by endoscope Patient treated with 5-aminosalislic acid (mesalamine)
Key exclusion criteria (2 listed)
- Patients with severe UC Pregnancy and lactating females Significant liver and kidney function abnormalities Diabetic patients Patients with Colorectal cancer patients Patients taking rectal or systemic steroids Patients on immunosuppressants or biological therapies Patients taking antacids, anticoagulants, bactericidal antibiotics, oral contraceptives, and isotretinoin.
- Addiction to alcohol and / or drugs Known allergy to the studied medications History of complete or partial colectomy.
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 |
|---|---|---|
| MesalazineMesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis | Drug | Minocycline group, control group |
| MinocyclineMinocycline is a tetracycline antibiotic medication used to treat a number of bacterial infections such as pneumonia. It is generally less preferred than the tetracycline doxycycline. Minocycline is also used for the treatment of acne and rheumatoid arthritis. | Drug | Minocycline group |
Primary outcome
Assessment of disease activity using Partial Mayo Scoring Index
Time frame: 6 months
Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity. It depends on three items; stool frequency, rectal bleeding (blood in stool) and Physician's Global Assessment. Each item has a score from 0 to 3 and total PMSI is the sum of scores for the three items.
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 18 Nov 2025.
- Derived from this study: PubMed 41128897Mashaly AF, Hegazy SK, Bahgat MM. Repurposing minocycline as an added-on treatment for ulcerative colitis patients on mesalamine: a randomized clinical pilot study. Naunyn Schmiedebergs Arch Pharmacol. 2026 Feb;399(3):4555-4568. doi: 10.1007/s00210-025-04662-2. Epub 2025 Oct 23.
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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 Mesalazine and Minocycline in people with Inflammatory Bowel Diseases, run by Mostafa Bahaa 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 2 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 18 Nov 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. 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?
Assessment of disease activity using Partial Mayo Scoring 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 NCT06201793, which also lists 1 linked publication.
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 18 Nov 2025.