Colchicine for Autoimmune and Subacute Thyroiditis (COLTHYR)

Colchicine as a Novel Anti-Inflammatory Strategy in Autoimmune and Subacute Thyroiditis: A Prospective Three-Arm Randomized Controlled Trial

Thyroiditis includes inflammatory thyroid disorders such as Hashimoto's thyroiditis and subacute thyroiditis. These conditions may cause thyroid pain, neck tenderness, elevated inflammatory markers, thyroid dysfunction, fatigue, and recurrence. Current management includes observation, symptomatic treatment, nonsteroidal anti-inflammatory drugs, and corticosteroids. Although corticosteroids may be effective, relapse after tapering and treatment-related adverse effects remain limitations. Colchicine is hypothesized to reduce inflammatory activity and may improve biochemical and clinical recovery. This study will evaluate the efficacy and safety of low-dose colchicine compared with corticosteroid therapy and supportive care in adults with autoimmune or subacute thyroiditis.

Study Overview

• Status: Recruiting
• Conditions: Thyroiditis; Hashimoto Thyroiditis; Subacute Thyroiditis
• Intervention / Treatment: Drug: colchicine; Drug: Prednisolone; Drug: NSAID

Detailed Description

Thyroiditis represents a heterogeneous group of inflammatory thyroid disorders. Hashimoto's thyroiditis is characterized by chronic autoimmune-mediated thyroid inflammation and progressive thyroid dysfunction. Subacute thyroiditis commonly presents with painful thyroid enlargement, elevated inflammatory markers, transient thyrotoxicosis, and possible later hypothyroidism.

Current treatment strategies include supportive care, nonsteroidal anti-inflammatory drugs, and corticosteroids. While corticosteroids often provide rapid symptomatic benefit, recurrence after withdrawal and steroid-related adverse effects remain clinically relevant concerns.

Colchicine inhibits microtubule polymerization, leukocyte migration, and inflammasome-mediated signaling. These mechanisms may provide potential benefit in thyroid inflammatory disease.

This prospective three-arm randomized controlled trial will compare colchicine, corticosteroid therapy, and supportive care regarding inflammatory improvement, thyroid function recovery, symptom control, recurrence, and tolerability.

Participants will be randomized in a 1:1:1 ratio and followed for six months. Primary outcomes include changes in C-reactive protein, erythrocyte sedimentation rate, and clinical symptom improvement. Secondary outcomes include thyroid function tests, thyroid autoantibodies, ultrasound improvement, recurrence rate, need for rescue corticosteroid therapy, and adverse events.

This study may help identify an effective steroid-sparing therapeutic strategy for inflammatory thyroid disorders.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Amr A. El Sehrawy, MD, PhD, FRCPE; Phone Number: +966503845019; Email: amrsehrawy@mans.edu.eg
• Study Contact Backup: Name: Amro A. Elbaz, MD; Phone Number: +201000191910; Email: dramrbaz@mans.edu.eg

Study Locations

• Egypt
  • Dakahlia Governorate
    • Al Mansurah, Dakahlia Governorate, Egypt, 35516
      • Recruiting
      • Mansoura University
      • Contact: Gamal I Ahmed, Department Secretary; Phone Number: +20 10 15613189
• Saudi Arabia
  • Mecca Region
    • Jeddah, Mecca Region, Saudi Arabia, 21461
      • Recruiting
      • Saudi German Hospital
      • Contact: Amani A Amodii, Member, Saudi German Hospital; Phone Number: +966531911630

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 to 70 years
• Newly diagnosed Hashimoto's thyroiditis or Subacute thyroiditis
• Diagnosis confirmed clinically, biochemically, and ultrasonographically
• Ability to provide written informed consent

Exclusion Criteria:

• Pregnancy or breastfeeding
• Severe renal impairment
• Severe hepatic disease
• Cytopenia
• Active serious infection
• Known hypersensitivity to colchicine
• Chronic corticosteroid use within previous 30 days
• Participation in another interventional trial
• Any condition affecting safety or protocol adherence

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colchicine; Participants will receive oral colchicine 0.5 mg twice daily for 12 weeks. Dose reduction to 0.5 mg once daily will be permitted if gastrointestinal intolerance occurs.	Drug: colchicine; Colchicine administered orally according to the study dosing protocol. Dose adjustments permitted based on tolerability and safety assessment.
Active Comparator: Prednisolone; Participants will receive oral prednisolone 20 mg daily for 14 days, followed by tapering by 5 mg every 1 to 2 weeks according to clinical response.	Drug: Prednisolone; Prednisolone administered orally according to the study treatment protocol with dose tapering based on clinical response and safety monitoring.
Active Comparator: Supportive Care; Participants will receive standard supportive care including analgesics, NSAIDs if clinically indicated, hydration advice, and monitoring.	Drug: NSAID; Non-steroidal anti-inflammatory drugs administered according to standard clinical practice and patient tolerance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in C-Reactive Protein (CRP)	Reduction in serum C-reactive protein concentration compared with baseline among treatment groups.	Baseline, Month 3, Month 6
Mean Change in Erythrocyte Sedimentation Rate (ESR)	Reduction in erythrocyte sedimentation rate compared with baseline among treatment groups.	Baseline, Month 3, Month 6
Mean Change in Thyroid Pain and Inflammatory Symptom from Baseline	Improvement in thyroid pain, neck tenderness, local discomfort, and inflammatory symptoms will be assessed using a standardized Thyroid Pain and Inflammatory Symptom Score ranging from 0 to 10, where higher scores indicate greater symptom severity and lower scores indicate clinical improvement.	Baseline, Month 1, Month 3, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence Rate of Thyroiditis	Number and proportion of participants experiencing clinical or biochemical recurrence of thyroiditis after initial improvement during follow-up.	Any recurrence during 6-month follow-up
Need for Rescue Corticosteroid Therapy	Number and proportion of participants requiring rescue corticosteroid treatment because of persistent symptoms, worsening inflammation, or inadequate clinical response.	Throughout 6-month follow-up
Adverse Events / Drug Intolerance	Frequency, type, and severity of adverse events or treatment intolerance including gastrointestinal symptoms, hepatic dysfunction, renal impairment, cytopenia, or steroid-related adverse effects.	Baseline to Month 6
Mean Change in Serum Thyroid-Stimulating Hormone (TSH) Concentration from Baseline	Assessment of changes in serum thyroid-stimulating hormone (TSH) concentrations compared with baseline values.	Baseline, Month 3, Month 6
Mean Change in Serum Free Triiodothyronine (Free T3) and Free Thyroxine (Free T4) Levels from Baseline	Assessment of changes in serum free triiodothyronine (Free T3) and free thyroxine (Free T4) concentrations compared with baseline values.	Baseline, Month 3, Month 6
Mean Change in Serum Thyroid Peroxidase Antibody (TPOAb) and Thyroglobulin Antibody (TgAb) Levels from Baseline	Assessment of changes in serum thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb) concentrations to evaluate autoimmune inflammatory activity.	Baseline, Month 6
Change in Thyroid Ultrasound Inflammatory Findings from Baseline	Assessment of changes in thyroid ultrasound characteristics, including gland vascularity, parenchymal heterogeneity, gland enlargement, and inflammatory changes compared with baseline findings.	Baseline, Month 6

Collaborators and Investigators

• Sponsor: Mansoura University
• Collaborators: Saudi German Hospital - Madinah
• Investigators: Study Chair: Amr A. El Sehrawy, MD, PhD, FRCPE, Faculty of Medicine, Mansoura University

Publications and helpful links

General Publications

• Bao RH, et al. Balancing the benefits and risks of colchicine use among patients with coronary heart disease. 2025. Colchicine exerts anti-inflammatory effects through inhibition of microtubule function, suppression of NLRP3 inflammasome activation, and reduction of hs-CRP.
• Plotz B, et al. New perspectives on the NLRP3 inflammasome: colchicine and suppression of inflammatory pathways in metabolic syndrome-associated diseases. Explor Musculoskeletal Dis. 2025;3:1007104.
• Li Y, Hu Y, Zhang Y, Cheng K, Zhang C, Wang J. Advances in Subacute Thyroiditis: Pathogenesis, Diagnosis, and Therapies. FASEB J. 2025 Apr 15;39(7):e70525. doi: 10.1096/fj.202403264R.
• Wang L, Zhu X, Xu S, Zhou B, Wu Y, Li Z, Zhao Y, Li S, Cheng F, Zhu L. Hashimoto's thyroiditis: from pathogenesis to clinical management. Front Endocrinol (Lausanne). 2026 Feb 2;17:1729316. doi: 10.3389/fendo.2026.1729316. eCollection 2026.
• Wolowiec L, Osiak-Gwiazdowska J, Jasniak A, Mucha W, Wojtaluk M, Czerniecka W, Wolowiec A, Banach J, Grzesk G. Colchicine in Contemporary Pharmacotherapy: Mechanistic Insights and Clinical Horizons. J Clin Med. 2025 Oct 7;14(19):7078. doi: 10.3390/jcm14197078.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Prednisolone; C-reactive protein; Colchicine; Randomized Trial; ESR; Autoimmune Thyroiditis; Thyroid Pain
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Thyroid Diseases; Pathological Conditions, Signs and Symptoms; Inflammation; Hashimoto Disease; Thyroiditis; Thyroiditis, Autoimmune; Thyroiditis, Subacute; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Heterocyclic Compounds; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Alkaloids; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Prednisolone; Colchicine; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: MU-THY-COL-2026-01; MD-MU-IRB-R.24.11.2879 (Other Identifier: Faculty of Medicine, Mansoura University Institutional Review Board, Egypt)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request to the corresponding author, following institutional approval and in accordance with ethical and confidentiality regulations.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years.
• IPD Sharing Access Criteria: Access to the data may be granted to qualified researchers for scientifically valid purposes after review and approval by the responsible institution and study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No