Clinical trial

Clinical Study to Evaluate the Possible Efficacy and Safety of Minocycline in Patients With Ulcerative Colitis Treated With Mesalamine

NCT06201793

Name

236977

Description

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

Trial arms

Trial start

2024-01-22

Estimated PCD

2027-01-20

Trial end

2028-08-20

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Minocycline group, control group

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.

Arms:

Minocycline group

Size

Primary endpoint

Assessment of disease activity using Partial Mayo Scoring Index

6 months

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}

Updated at

2024-01-30

1 organization

2 products

1 indication

Organization

Mostafa Bahaa

Product

Mesalazine

Indication

Inflammatory Bowel Disease

Product

Minocycline