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Microbiota Transfer
Microbiota Transfer for Chronic Sinusitis (SNMT Trial)
N/A
Recruiting
Research Sponsored by Amin Javer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with CRS (with/without polyps) and have previously undergone functional endoscopic sinus surgery (Post-FESS)
Have deteriorating SNOT-22 Scores (≥20) or do not improve after surgery and appropriate maximal medical management (MLK score ≥ 2, with at least 2 points on the discharge subdomain)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 45 days, 90 days, 180 days
Awards & highlights
SNMT Trial Summary
This trial will test whether a sinus power wash combined with a sinus microbiota transfer from a healthy donor can improve clinical outcomes in people with chronic sinusitis.
Who is the study for?
This trial is for adults with stubborn chronic sinusitis who've had sinus surgery and max medical treatment but still suffer. They must be able to consent and have a SNOT-22 Score ≥20 or no improvement post-surgery. Excluded are immune-compromised, those outside the US, with sinonasal tumors, certain infections/diseases, autoimmune diseases affecting airways, recent other respiratory conditions except common colds, active cancer history or specific risk factors.Check my eligibility
What is being tested?
The study tests if transferring healthy sinus microbes from screened donors into patients' sinuses (SNMT) after a 'sinus power wash' can improve chronic sinusitis. It's a double-blind trial where half get real SNMT and half get sham transfers to compare outcomes.See study design
What are the potential side effects?
Potential side effects aren't detailed in the provided information but may include discomfort or complications from the endoscopic procedure or 'sinus power wash', as well as risks associated with transferring microbiota such as infection.
SNMT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have chronic sinusitis, with or without polyps, and have had sinus surgery.
Select...
My sinus symptoms are getting worse or not improving despite treatment and surgery.
Select...
I am 19 years old or older.
SNMT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 45 days, 90 days, 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 45 days, 90 days, 180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Modified Lund-Kennedy (MLK) endoscopic scoring
Secondary outcome measures
Adverse and serious adverse events
Immune markers
Microbiome analysis of patients and donor samples
+2 moreSNMT Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sinonasal Microbiota TransferExperimental Treatment1 Intervention
The transfer site for patients will be prepared by endoscopically removing any visible crusting, mucin, and purulent discharge from the sinuses and via manual high-volume (>60 ml), high-pressure saline wash on day 0. The donor mucus sample will be homogenized using sterile, disposable rotor-stator homogenizer tips for 30 seconds and 5 ml of donor mucus will be instilled into the affected sinus cavity(ies) using a masked syringe under endoscopic visualization, with the recipient's head in a dependent position. Patients will remain in this position for 15 minutes to facilitate transfer.
Group II: Sham Sinonasal Microbiota TransferPlacebo Group1 Intervention
Sterile saline will replace the SNMT donor mucus in the masked syringe and will be delivered in an identical manner to the SNMT intervention.
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Who is running the clinical trial?
Amin JaverLead Sponsor
Amin Javer, MDStudy DirectorUniversity of British Columbia
5 Previous Clinical Trials
352 Total Patients Enrolled
4 Trials studying Sinusitis
252 Patients Enrolled for Sinusitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor expects I have more than 6 months to live despite my severe illness.People who have not responded well to treatment for cytokine release syndrome.I am 19 years old or older.I have been diagnosed with a tumor in my nasal passages.I have a condition that affects the clearing of mucus from my lungs.My condition hasn't improved despite receiving the best possible treatment.I have chronic sinusitis, with or without polyps, and have had sinus surgery.My sinus symptoms are getting worse or not improving despite treatment and surgery.I am a donor and I do not have any specific infections or diseases.You have had significant sinus or lung disease in the last 2 years, asthma, or weakened immune system. You have also had recent blood transfusions, antibiotic treatments, or immunosuppressive medications.I have an autoimmune disease like lupus, Sjögren's, or systemic sclerosis.Patients with weakened immune systems.I cannot tolerate standard nerve medication.
Research Study Groups:
This trial has the following groups:- Group 1: Sinonasal Microbiota Transfer
- Group 2: Sham Sinonasal Microbiota Transfer
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots remaining in this research project?
"As per information on clinicaltrials.gov, this medical trial has opened recruitment to patients and is open for participation as of June 15th 2022. Subsequent modifications were made most recently on July 15th of the same year."
Answered by AI
What are the major goals of this medical experiment?
"The primary metric of success for this study is the Modified Lund-Kennedy endoscopic score, which will be monitored from baseline to day 45. Additional objectives include reducing SNOT-22 quality of life scores by 9 or more points in 45 days post SNMT; performing whole metagenome shotgun 16s rRNA sequencing and metabolomics on sinus mucosal aspirates; as well as assessing patient's CRS related symptoms through the Sinonasal Outcome Test (SNOT-22) questionnaire."
Answered by AI
How many participants are currently undergoing this research project?
"Yes, the data available on clinicaltrials.gov indicates that this study is actively recruiting individuals to participate. This trial was initially made public June 15th 2022 and the most recent update came July 15th 2022; they are looking for 80 participants at a single site."
Answered by AI
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