Rhinitis, AllergicNCT06372184
Washed Microbiota Transplantation for Allergic Rhinitis
A study testing Washed Microbiota Transplantation in people with Rhinitis, Allergic, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic
- What is being tested?
- Washed Microbiota Transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old.
- Meets the diagnostic criteria for allergic rhinitis.
- rTNSS score greater than or equal to 6 points.
- The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.
- -
Who cannot join
- Patients with acute nasosinusitis or upper respiratory tract infection.
- Patients diagnosed with chronic sinusitis, nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases or have undergone nasal surgery.
- Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the past two weeks.
- Patients with poor lung function.
- Patients with severe liver, kidney, and heart diseases
- Patients with known psychiatric or neurological diseases.
Show all 9Show fewer
- Patients who use antihistamines, glucocorticoids, decongestants, mast cell membrane stabilizers, leukotriene antagonists in the past two weeks.
- According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, MD,PhD, 086-25-58509883, fzhang@njmu.edu.cn
About this study
Official title: Efficacy and Safety of Washed Microbiota Transplantation for Allergic Rhinitis: A Randomized, Double-blind, Placebo-controlled Study
Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR.
Read the detailed description
Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. The prevalence of AR has been reported from 5% to 50% worldwide which is dependent on the method of diagnosis and age of participants studied. AR is often co-morbid with asthma and/or conjunctivitis, which affects patients' daily life and carries a huge economic burden.
Increasing evidence showed that gut microbiota can influence the development of AR. Fecal Microbiota transplantation (FMT), the most classic way to treat diseases using gut microbiota, refers to the transplantation of functional microbiota in the feces of healthy people into the intestines of patients. It can reconstruct the overall gut microbiota of patients, thus treating gastrointestinal disease and external gastrointestinal diseases of patients. Washed microbiota transplantation (WMT), a new stage of FMT, is based on the automatic microfiltration machine (GenFMTer, Nanjing, China) and the following repeated centrifugation plus suspension with support from specific facilities. Compared with manual FMT, WMT can reduce the rate of adverseevents (such as fever, diarrhea, abdominal pain, abdominal distension, nausea and vomiting, etc.) without affecting the efficacy.
In clinical practice, we found that WMT could significantly improve the nasal symptoms of AR. This clinical trial aims to evaluate the efficacy and safety of WMT for AR.
- Conditions
- Rhinitis, Allergic
- Being tested
- Washed Microbiota Transplantation, Placebo
- Keywords
- washed microbiota transplantation, allergic rhinitis, reflective total nasal symptom score, rhinoconjunctivitis quality of life questionnaire score, gut microbiota
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Washed Microbiota TransplantationDrug
Also called Fecal Microbiota Transplantation
Patients take four capsules containing washed microbiota once a day for five consecutive days
PlaceboDrug
Also called Capsule
Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Washed microbiota transplantation | Experimental | Patients take four capsules containing washed microbiota once a day for five consecutive days Receives: Drug: Washed Microbiota Transplantation |
| Placebo | Placebo comparator | Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the reflective total nasal symptom score (rTNSS)
TNSS is expressed as the sum of the scores for the four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing) in the past 12 hours. Each symptom was rated on a 4-point scale from 0 (none) through 1 (mild), 2 (moderate), and 3 (severe).
Measured: baseline, one weeks, four weeks, twelve weeks post WMT
Secondary outcomes (8)
Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score
RQLQ is used to evaluate the degree of impact of chronic rhinitis on the quality of life of patients, including activities (3 "patient-specific") limitation, sleep problems (3 items), nose symptoms (4 items), eye symptoms (4 items), non-nose/eye symptoms (7 items), practical problems (3 items) and emotional function (4 items)).
Measured: baseline, one weeks, four weeks, twelve weeks post WMT
Changes in the single reflective nasal symptoms score
The severity of the single reactive nasal symptoms (rhinorrhea, stuffy nose, itchy nose, and sneezing) in the past 12 hours. Each symptom was rated on a 4-point scale from 0 (none) through 1 (mild), 2 (moderate), and 3 (severe).
Measured: baseline, one weeks, four weeks, twelve weeks post WMT
Changes in the concentration of specific IgE
The immunologic function is evaluated through specific IgE.
Measured: baseline, one day, four weeks, twelve weeks post WMT
Changes in the concentration of inflammatory factors
The immunologic function is evaluated through inflammatory factors.
Measured: baseline, one day, four weeks, twelve weeks post WMT
Changes in the number of immune cell
The immunologic function is evaluated through flow cytometric analysis of lymphocyte clusters.
Measured: baseline, one day, four weeks, twelve weeks post WMT
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
Measured: One day, one week, four weeks, twelve weeks post WMT
Changes in the Modified Lund-Kennedy endoscopic score
Modified Lund-Kennedy endoscopic score scoring system is based on assessing polyps, oedema, and discharge.
Measured: baseline, four weeks, twelve weeks post WMT
Changes in composition and metabolites of gut microbiota and nasal microbiota
The composition of the gut microbiota and nasal microbiota is evaluated by sequencing fecal metagenome. We evaluate the differences in the structure and its metabolism at the phylum, genus and species levels.
Measured: baseline, one day, four weeks, twelve weeks post WMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, MD,PhD, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372184
- Sponsor's protocol ID
- WMT-AR-RCT
- Status last verified
- May 2024
- First submitted
- 15 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wise SK, Damask C, Roland LT, Ebert C, Levy JM, Lin S, Luong A, Rodriguez K, Sedaghat AR, Toskala E, Villwock J, Abdullah B, Akdis C, Alt JA, Ansotegui IJ, Azar A, Baroody F, Benninger MS, Bernstein J, Brook C, Campbell R, Casale T, Chaaban MR, Chew FT, Chambliss J, Cianferoni A, Custovic A, Davis EM, DelGaudio JM, Ellis AK, Flanagan C, Fokkens WJ, Franzese C, Greenhawt M, Gill A, Halderman A, Hohlfeld JM, Incorvaia C, Joe SA, Joshi S, Kuruvilla ME, Kim J, Klein AM, Krouse HJ, Kuan EC, Lang D, Larenas-Linnemann D, Laury AM, Lechner M, Lee SE, Lee VS, Loftus P, Marcus S, Marzouk H, Mattos J, McCoul E, Melen E, Mims JW, Mullol J, Nayak JV, Oppenheimer J, Orlandi RR, Phillips K, Platt M, Ramanathan M Jr, Raymond M, Rhee CS, Reitsma S, Ryan M, Sastre J, Schlosser RJ, Schuman TA, Shaker MS, Sheikh A, Smith KA, Soyka MB, Takashima M, Tang M, Tantilipikorn P, Taw MB, Tversky J, Tyler MA, Veling MC, Wallace D, Wang Y, White A, Zhang L. International consensus statement on allergy and rhinology: Allergic rhinitis - 2023. Int Forum Allergy Rhinol. 2023 Apr;13(4):293-859. doi: 10.1002/alr.23090. Epub 2023 Mar 6.
PubMed 36878860Bousquet J, Anto JM, Bachert C, Baiardini I, Bosnic-Anticevich S, Walter Canonica G, Melen E, Palomares O, Scadding GK, Togias A, Toppila-Salmi S. Allergic rhinitis. Nat Rev Dis Primers. 2020 Dec 3;6(1):95. doi: 10.1038/s41572-020-00227-0.
PubMed 33273461Martensson A, Cervin-Hoberg C, Huygens F, Lindstedt M, Sakellariou C, Greiff L, Cervin A. Upper airway microbiome transplantation for patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2023 Jun;13(6):979-988. doi: 10.1002/alr.23122. Epub 2023 Jan 1.
PubMed 36515012Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.
PubMed 31919742Schaefer M, Zimmermann K, Enck P. Probiotic treatment (Enterococcus faecalis) improves symptoms of seasonal allergic rhinitis: A randomized controlled trial. Int Forum Allergy Rhinol. 2023 Oct;13(10):1974-1977. doi: 10.1002/alr.23154. Epub 2023 Apr 7. No abstract available.
PubMed 36922364Anania C, Di Marino VP, Olivero F, De Canditiis D, Brindisi G, Iannilli F, De Castro G, Zicari AM, Duse M. Treatment with a Probiotic Mixture Containing Bifidobacterium animalis Subsp. Lactis BB12 and Enterococcus faecium L3 for the Prevention of Allergic Rhinitis Symptoms in Children: A Randomized Controlled Trial. Nutrients. 2021 Apr 16;13(4):1315. doi: 10.3390/nu13041315.
PubMed 33923532Kang MG, Han SW, Kang HR, Hong SJ, Kim DH, Choi JH. Probiotic NVP-1703 Alleviates Allergic Rhinitis by Inducing IL-10 Expression: A Four-week Clinical Trial. Nutrients. 2020 May 15;12(5):1427. doi: 10.3390/nu12051427.
PubMed 32429063
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Washed Microbiota Transplantation for Allergic Rhinitis: A Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06372184
- Acronym / sponsor ID
- WMT-AR-RCT
- Conditions
- Rhinitis, Allergic
- Keywords
- washed microbiota transplantation, allergic rhinitis, reflective total nasal symptom score, rhinoconjunctivitis quality of life questionnaire score, gut microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR.
Detailed description
Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. The prevalence of AR has been reported from 5% to 50% worldwide which is dependent on the method of diagnosis and age of participants studied. AR is often co-morbid with asthma and/or conjunctivitis, which affects patients' daily life and carries a huge economic burden.
Increasing evidence showed that gut microbiota can influence the development of AR. Fecal Microbiota transplantation (FMT), the most classic way to treat diseases using gut microbiota, refers to the transplantation of functional microbiota in the feces of healthy people into the intestines of patients. It can reconstruct the overall gut microbiota of patients, thus treating gastrointestinal disease and external gastrointestinal diseases of patients. Washed microbiota transplantation (WMT), a new stage of FMT, is based on the automatic microfiltration machine (GenFMTer, Nanjing, China) and the following repeated centrifugation plus suspension with support from specific facilities. Compared with manual FMT, WMT can reduce the rate of adverseevents (such as fever, diarrhea, abdominal pain, abdominal distension, nausea and vomiting, etc.) without affecting the efficacy.
In clinical practice, we found that WMT could significantly improve the nasal symptoms of AR. This clinical trial aims to evaluate the efficacy and safety of WMT for AR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Washed microbiota transplantation | Experimental | Drug: Washed Microbiota TransplantationPatients take four capsules containing washed microbiota once a day for five consecutive days |
| Placebo | Placebo comparator | Drug: PlaceboPatients take four capsules in the same packaging as the experimental group once a day for five consecutive days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years old.
- Meets the diagnostic criteria for allergic rhinitis.
- rTNSS score greater than or equal to 6 points.
- The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.
- -
Key exclusion criteria (9 listed)
- Patients with acute nasosinusitis or upper respiratory tract infection.
- Patients diagnosed with chronic sinusitis, nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases or have undergone nasal surgery.
- Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the past two weeks.
- Patients with poor lung function.
- Patients with severe liver, kidney, and heart diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Washed Microbiota TransplantationAlso: Fecal Microbiota TransplantationPatients take four capsules containing washed microbiota once a day for five consecutive days | Drug | Washed microbiota transplantation |
| PlaceboAlso: CapsulePatients take four capsules in the same packaging as the experimental group once a day for five consecutive days | Drug | Placebo |
Primary outcome
Changes in the reflective total nasal symptom score (rTNSS)
Time frame: baseline, one weeks, four weeks, twelve weeks post WMT
TNSS is expressed as the sum of the scores for the four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing) in the past 12 hours. Each symptom was rated on a 4-point scale from 0 (none) through 1 (mild), 2 (moderate), and 3 (severe).
8 secondary outcomes
Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score
Time frame: baseline, one weeks, four weeks, twelve weeks post WMT
Changes in the single reflective nasal symptoms score
Time frame: baseline, one weeks, four weeks, twelve weeks post WMT
Changes in the concentration of specific IgE
Time frame: baseline, one day, four weeks, twelve weeks post WMT
Changes in the concentration of inflammatory factors
Time frame: baseline, one day, four weeks, twelve weeks post WMT
Changes in the number of immune cell
Time frame: baseline, one day, four weeks, twelve weeks post WMT
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
Time frame: One day, one week, four weeks, twelve weeks post WMT
Changes in the Modified Lund-Kennedy endoscopic score
Time frame: baseline, four weeks, twelve weeks post WMT
Changes in composition and metabolites of gut microbiota and nasal microbiota
Time frame: baseline, one day, four weeks, twelve weeks post WMT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 36878860Wise SK, Damask C, Roland LT, Ebert C, Levy JM, Lin S, Luong A, Rodriguez K, Sedaghat AR, Toskala E, Villwock J, Abdullah B, Akdis C, Alt JA, Ansotegui IJ, Azar A, Baroody F, Benninger MS, Bernstein J, Brook C, Campbell R, Casale T, Chaaban MR, Chew FT, Chambliss J, Cianferoni A, Custovic A, Davis EM, DelGaudio JM, Ellis AK, Flanagan C, Fokkens WJ, Franzese C, Greenhawt M, Gill A, Halderman A, Hohlfeld JM, Incorvaia C, Joe SA, Joshi S, Kuruvilla ME, Kim J, Klein AM, Krouse HJ, Kuan EC, Lang D, Larenas-Linnemann D, Laury AM, Lechner M, Lee SE, Lee VS, Loftus P, Marcus S, Marzouk H, Mattos J, McCoul E, Melen E, Mims JW, Mullol J, Nayak JV, Oppenheimer J, Orlandi RR, Phillips K, Platt M, Ramanathan M Jr, Raymond M, Rhee CS, Reitsma S, Ryan M, Sastre J, Schlosser RJ, Schuman TA, Shaker MS, Sheikh A, Smith KA, Soyka MB, Takashima M, Tang M, Tantilipikorn P, Taw MB, Tversky J, Tyler MA, Veling MC, Wallace D, Wang Y, White A, Zhang L. International consensus statement on allergy and rhinology: Allergic rhinitis - 2023. Int Forum Allergy Rhinol. 2023 Apr;13(4):293-859. doi: 10.1002/alr.23090. Epub 2023 Mar 6.
- Background: PubMed 33273461Bousquet J, Anto JM, Bachert C, Baiardini I, Bosnic-Anticevich S, Walter Canonica G, Melen E, Palomares O, Scadding GK, Togias A, Toppila-Salmi S. Allergic rhinitis. Nat Rev Dis Primers. 2020 Dec 3;6(1):95. doi: 10.1038/s41572-020-00227-0.
- Background: PubMed 36515012Martensson A, Cervin-Hoberg C, Huygens F, Lindstedt M, Sakellariou C, Greiff L, Cervin A. Upper airway microbiome transplantation for patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2023 Jun;13(6):979-988. doi: 10.1002/alr.23122. Epub 2023 Jan 1.
- Results publication: PubMed 31919742Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.
- Results publication: PubMed 36922364Schaefer M, Zimmermann K, Enck P. Probiotic treatment (Enterococcus faecalis) improves symptoms of seasonal allergic rhinitis: A randomized controlled trial. Int Forum Allergy Rhinol. 2023 Oct;13(10):1974-1977. doi: 10.1002/alr.23154. Epub 2023 Apr 7. No abstract available.
- Results publication: PubMed 33923532Anania C, Di Marino VP, Olivero F, De Canditiis D, Brindisi G, Iannilli F, De Castro G, Zicari AM, Duse M. Treatment with a Probiotic Mixture Containing Bifidobacterium animalis Subsp. Lactis BB12 and Enterococcus faecium L3 for the Prevention of Allergic Rhinitis Symptoms in Children: A Randomized Controlled Trial. Nutrients. 2021 Apr 16;13(4):1315. doi: 10.3390/nu13041315.
- Results publication: PubMed 32429063Kang MG, Han SW, Kang HR, Hong SJ, Kim DH, Choi JH. Probiotic NVP-1703 Alleviates Allergic Rhinitis by Inducing IL-10 Expression: A Four-week Clinical Trial. Nutrients. 2020 May 15;12(5):1427. doi: 10.3390/nu12051427.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faming Zhang, MD,PhD principal investigator
The Second Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Washed Microbiota Transplantation in people with Rhinitis, Allergic, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faming Zhang, MD,PhD (086-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the reflective total nasal symptom score (rTNSS) (time frame: baseline, one weeks, four weeks, twelve weeks post WMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06372184, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.