Minocyclin in Ulcerative Colitis as Added on Therapy

NCT06201793 | Completed Phase 2

• 1 other identifier: 236977
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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 environmental factors, and 20% to 40% of patients with UC also exhibit extraintestinal manifestations involving the joints, skin, eyes, or hepatobiliary tract

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

control group

ACTIVE COMPARATOR

control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months.

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.

Drug: Mesalazine; Drug: Minocycline

Interventions

Mesalazine DRUG

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

Minocycline group; control group

Minocycline DRUG

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.

Minocycline group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mostafa Bahaa: lead
• Amira Fawzy Mohamed Mashaly, Clinical Pharmacy Demonstrator, Faculty of Pharmacy- Horus University: collaborator
• Tanta University: collaborator
• Mounir Hussein Bahgat Internal Medicine Department Mansoura University: collaborator

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, 7650001, Egypt

Location

Related Publications (1)

• 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. 2025 Oct 23. doi: 10.1007/s00210-025-04662-2. Online ahead of print.

  PMID: 41128897 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Mesalamine; Minocycline

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching assisstant

Study Record Dates

• First Submitted: December 31, 2023
• First Posted: January 11, 2024
• Study Start: January 22, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

EG (1)