Phase-II Randomized Control Trial of Nasal Microbiota Transplant Therapy in Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Chronic Rhinosinusitis (CRS) is a chronic inflammatory condition of the nasal passage and paranasal sinuses that places significant burden on affected patients and global healthcare systems. Current treatments for CRS such as long-term antibiotics, anti-inflammatory drugs, and surgery often reduce symptoms and signs of disease temporarily, however long-term results are much less satisfactory. Recently, the theory of a damaged microbiome (dysbiosis) as a cause or promoting factor behind CRS has gained increasing evidence from the scientific community. A condition of the gut with microbial dysbiosis (c.difficile) has previously employed microbiota transplant treatment with great success in long-term health outcomes. Such treatments are shown to repopulate bacterial microenvironment and restore protective commensal bacterial load. A pilot study conducted by this study team trialed a novel intervention of a Nasal Microbiota Transplant in a small group of participants. Preliminary results suggested significantly improved CRS symptoms after treatment with a healthy donor microbiota transplant, compared to the pre-transplant baseline. The addition of a randomized-control trial with inclusion of a placebo group is the next step. In this study, investigators aim to perform a two-arm, double-blinded, phase II randomized controlled clinical trial in order to assess the efficacy of a Nasal Microbiota Transplant against a placebo in a cohort of CRS patients without Nasal Polyps (CRSsNP).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• Diagnosis of Chronic Rhinosinusitis as defined by the presence of 2 or more major sinonasal symptoms (nasal blockage, nasal discharge, loss of smell, and facial pain/ fullness) for a minimum of 12 weeks

• Endoscopic confirmation of middle meatus inflammation or presence of mucopurulence, and /or CT confirmation of paranasal sinus inflammation.

• Previous nasal surgery with patent ostia to the diseased ethmoids and maxillary sinuses

• Signed written informed consent

• No history of sinonasal or lower airway disease for the last 2 years other than the common cold.

• No clinical findings of sinonasal disease at the inclusion visit.

• Accepted as a donor by the patient.

• Signed informed consent to participate in the study.

Locations
Other Locations
Australia
Royal Brisbane and Women's Hospital
RECRUITING
Brisbane
University of Queensland
NOT_YET_RECRUITING
Brisbane
Monash Health
NOT_YET_RECRUITING
Melbourne
Contact Information
Primary
Anders Cervin, MD,FRACS
a.cervin@uq.edu.au
617 3497 3588
Backup
Diane Maresco-Pennisi, PhD
d.marescopennisi@uq.edu.au
617 3346 6072
Time Frame
Start Date: 2022-11-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Experimental: Intervention
For each nostril, the donated nasal wash sample is quiesced to 15 mls with saline Nasal Microbiota Transplant therapy.
Placebo_comparator: Control
For each nostril, 15 mls of saline will be used as the placebo therapy.
Sponsors
Collaborators: Monash Health, Royal Brisbane and Women's Hospital, Queensland University of Technology
Leads: The University of Queensland

This content was sourced from clinicaltrials.gov