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Efficacy and Safety of Fecal Microbiota Transplantation in Severe Allergic Rhinitis Patients Induced by Artemisia Pollen: A Prospective, Multicenter, Randomized Controlled Trial.

Efficacy and Safety of Fecal Microbiota Transplantation in Severe Allergic Rhinitis Patients Induced by Artemisia Pollen: A Prospective, Multicenter, Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093396
Enrollment
Unknown
Registered
2024-12-04
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis

Interventions

A Group:Participants will receive a single course of Fecal Microbiota Transplantation (FMT) treatment, followed by a 28-day observation period.
B Group:Participants will undergo two courses of Fecal Microbiota Transplantation (FMT) treatment
C Group:Participants will receive three courses of FMT treatment

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Eligibility Criteria for Participants in This Study Participants must meet all of the following criteria to be included in this study: 1. Diagnosed with Allergic Rhinitis. The diagnosis must conform to the standards of the "Chinese Guidelines for Diagnosis and Treatment of Allergic Rhinitis (Revised Edition, 2022)." The basis for diagnosis includes: - Symptoms: Two or more of the following symptoms occurring sporadically: sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with symptoms lasting or accumulating for more than 1 hour per day, possibly accompanied by tearing, eye itching, and redness of the eyes. - Signs: Commonly observed pale and edematous nasal mucosa, and watery nasal discharge. - Allergen Testing: At least one positive allergen skin prick test (SPT) and/or specific serum IgE, or a positive nasal challenge test. 2. Determined by the study physician to be sensitized to Artemisia pollen, meeting at least one of the following: - Serum sIgE or skin prick test positive to Artemisia allergens. - Positive nasal provocation test induced by Artemisia allergens. - Exacerbation of respiratory symptoms or poor disease control during the pollen season of Artemisia. 3. Total Nasal Symptom Score (TNSS) = 8 points. 4. Ages between 18-60 years, with no gender restrictions. 5. Patients voluntarily participate in the study, have fully understood the potential risks and benefits of FMT, and have signed an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Participants in This Study Patients who meet any of the following criteria must be excluded from this study: 1. Severe Organ Dysfunction: Patients with severe dysfunction of the heart, liver, kidneys, or other organs. 2. Immune Deficiency or Immunosuppressive Treatment: Patients with immune deficiencies or those undergoing immunosuppressive therapy. 3. Bleeding Disorders or Coagulation Dysfunction: Patients with hemorrhagic disorders or coagulation abnormalities. 4. Mental Illness History or Cognitive Impairment: Patients with a history of mental illness or cognitive disorders. 5. Active Neoplasms, Infections, or Acute Inflammatory Diseases: Patients with active tumors, infections, or acute inflammatory conditions. 6. Gastrointestinal Surgery or Major Gastrointestinal Diseases: Patients with a history of gastrointestinal surgery or significant gastrointestinal disorders. 7. Allergy to FMT Donor Components: Patients allergic to components of the FMT donor. 8. History of Alcohol or Drug Abuse: Patients with a history of alcohol or drug abuse within the past year. 9. Use of Probiotics, Prebiotics, or Other Gut Microbiota-Altering Agents: Patients who have used probiotics, prebiotics, or other agents that may affect the gut microbiota within the past three months. 10. Pregnancy or Lactation: Women who are pregnant or breastfeeding. 11. Inability to Undergo Proper Bowel Preparation or Gastrointestinal Dysfunction: Patients who are unable to undergo appropriate bowel preparation or have severe gastrointestinal dysfunction such as constipation. 12. Unstable Medical Conditions as Determined by the Investigator: Any medical condition that may affect patient safety during the study, confound or affect the scientific validity of the study outcomes, or hinder the patient's ability to complete the entire study, or make it unlikely for the patient to adhere to study procedures, restrictions, and requirements. 13. Participation in Other Clinical Trials: Patients currently participating in other drug clinical trials.

Design outcomes

Primary

MeasureTime frame
FMT efficacy rate;Safety;

Countries

China

Contacts

Public ContactYun Liu

The Second Affiliated Hospital of Xi'an Jiaotong University.

27556828@qq.com+86 357 288 7605

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026