Minocyclin in Ulcerative Colitis as Added on Therapy

November 15, 2025 updated by: Mostafa Bahaa

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Mansurah, Egypt, 7650001
        • Faculty of medicine, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months.
Drug: Mesalazine
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
Active Comparator: Minocycline group
minocycline group, n = 23) will receive 1 g mesalamine three times daily plus 100 mg minocycline orally twice daily for 6 months.
Drug: Mesalazine
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
Drug: Minocycline
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mostafa Bahaa

Collaborators

Tanta University
Mounir Hussein Bahgat Internal Medicine Department Mansoura University
Amira Fawzy Mohamed Mashaly, Clinical Pharmacy Demonstrator, Faculty of Pharmacy- Horus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Actual)

January 20, 2025

Study Completion (Actual)

January 20, 2025

Study Registration Dates

First Submitted

December 31, 2023

First Submitted That Met QC Criteria

December 31, 2023

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 15, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 236977

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammatory Bowel Diseases

Clinical Trials on Mesalazine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe