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Trial record 1 of 1 for:    fecal transplant | "Sinusitis"
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Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

This study is currently recruiting participants.
Verified April 2017 by Region Skane
Sponsor:
ClinicalTrials.gov Identifier:
NCT03122795
First Posted: April 21, 2017
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Region Skane
  Purpose

Chronic rhinosinusitis (CRS) is a disease associated with impaired quality of life and substantial societal costs. Though sometimes co-appearing with other conditions, such as asthma, allergy, and nasal polyps, many cases present without co-morbidities. Micro-biological diagnostic procedures are frequently undertaken, but the results are often inconclusive. Nevertheless, antibiotics are usually prescribed, but invariably with limited and temporary success. Accordingly, there is a need for new treatments for CRS.

Recent studies indicate that the sinuses are colonized by a commensal microbiome of bacteria and that damage to this natural microbiome, by pathogens or antibiotics, may cause an imbalance that may promote CRS. Therefore, treatments that restore the commensal microbiome may offer an alternative to current protocols. Arguably, as suggested by studies on patients with intestinal infections (next paragraph), one such possibility may be to transfer a "normal microbiome" to patients with CRS.

A disrupted microbiome is linked to intestinal clostridium difficile infections. Probiotic restitution therapy may be effective even in cases recalcitrant to antibiotic treatment. However, a key to effective probiotic restitution is selecting the bacteria that facilitate regrowth of normal microbiome. As an answer to this, researchers have chosen to simply transplant the entire microbiome from a healthy donor. In the case of clostridium difficile infection in the form of faecal transplants.

In this study, we will examine the possibility to treat patients with chronic rhinosinusitis without polyps (CRSsNP) with complete sinonasal microbiomes obtained from healthy donors. Our analysis will focus on symptoms and signs of disease as well as on nasal inflammatory and microbiological indices.


Condition Intervention
Chronic Rhinosinusitis (Diagnosis) Procedure: Microbiome transplant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Patients and donors who meet the inclusion criteria will be recruited and inclueded and put through the study in a cumulative fashion.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • SNOT-22 [ Time Frame: Day 1 to day 106 ]
    Change of burden of disease as measured by the SNOT-22 (22 item sinonasal outcome test) questionnaire in patients


Secondary Outcome Measures:
  • Lund Kennedy endoscopy score [ Time Frame: Day 1 to day 106 ]
    Grading of burden of disease as measured using the Lund-Kennedy endoscopy score.

  • Subjective symptom score [ Time Frame: Day 1 to 106. ]
    Subjective scoring of symptoms related to sinonasal, lower airway, intestinal and other

  • Inflammatory burden [ Time Frame: Day 1 to day 106 ]
    Amount of inflammatory mediators collected in nasal lavages.

  • Microflora [ Time Frame: Day 1 to day 106 ]
    Change in nasal microflora measured using both culture dependant and non culture dependant microbiological techniques.


Estimated Enrollment: 30
Actual Study Start Date: May 15, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: August 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microbiome transplant
The only arm of the study. Patients suffering from CRSsNP gets microbiome transplants from donors without any sinonasal health problems.
Procedure: Microbiome transplant
A raw microbiome, collected from a donor without any sinonasal health problems, as a nasal lavage.

Detailed Description:

Over the last few years the theory of a damaged microbiome as a cause or promoting factor behind chronic rhinosinusitis has gained increasing interest from the scientific community.

A number of studies aimed at investigating the microbiota of the nose and paranasal sinuses in health and disease has been published with very varying outcomes. Furthermore, other studies have been aimed at probiotic treatment of sinonasal disease either locally or through immunologic manipulation via the gastrointestinal microbiota.

A problem common to all these studies is that studies examining the normal nasal microbiota have identified a great amount of different bacterial species. It is as of today not known which individual species or combinations of species that promotes health.

The probiotic assemblages examined in previous studies have consisted of one or a combination of a few bacterial species.

Probiotic restitution therapy has been proven very effective for intestinal clostridium difficile infections. The restitution therapy has then consisted of transplantation of a complete microbiome from a healthy donor in the form of a faecal transplant.

In this study the investigators aim at recruiting patients suffering from chronic rhinosinusitis without polyps (CRSsNP) and healthy participants without any history sinonasal disease. The patients and the healthy participants will be examined for infectious diseases in a manner similar to other medical transplant procedures to minimize the risk for the recipients. The patients will then be treated with antibiotics to reduce the bacterial load of the nose and the paranasal sinuses. After the patient has finished the antibiotic treatment a microbiome transplant will be harvested from the healthy participant as a nasal lavage. The raw lavage fluid will then be used to transplant the microbiome to the patient. The procedure will be repeated for five consecutive days.

The outcome measures analysed will focus on subjective sinonasal health and symptoms of the patients but also include nasal inflammatory and microbiological indices.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria (patient)

  • 2 nasal symptoms: 1 of which must be nasal obstruction or discoloured discharge.
  • Sinusitis verified by endoscopy or CT-scan.
  • Duration > 12 weeks.
  • Previous surgery with patent ostia to the diseased sinuses.
  • Signed informed consent to participate in the study.

Inclusion criteria (donor)

  • No history of sinonasal or lower airway disease within the last 2 years other than the common cold.
  • Accepted as a donor by the patient.
  • Signed informed consent to participate in the study.

Exclusion criteria (patient)

  • Nasal polyposis.
  • Antibiotic treatment within the last 4 weeks.
  • On-going or recent participation in another clinical trial.
  • Any medication that may affect the results in an unpredictable manner.
  • Immune deficiency.
  • Allergy to amoxicillin or clavulanate potassium and clarithromycin.
  • Pregnancy or breastfeeding.

Exclusion criteria (donor)

  • Chronic rhinosinusitis.
  • Acute rhinosinusitis within the last two years.
  • Nasal polyposis.
  • Asthma.
  • Antibiotic treatment within the last 4 weeks.
  • On-going or recent participation in another clinical trial.
  • Clinical findings of sinonasal disease at the inclusion visit.
  • Findings in the pre-study pathogen scan that makes the donor unsuitable.
  • Pregnancy or breastfeeding.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122795


Contacts
Contact: Anders Mårtensson, MD +46768617200 anders.s.martensson@skane.se
Contact: Anders Cervin, MD PhD +61467980662 acervin@me.com

Locations
Sweden
Departement of ORL Recruiting
Helsingborg, Sweden, 25187
Contact: Anders Mårtensson, MD    +46768617200    anders.martensson.1763@med.lu.se   
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Anders Mårtensson, MD Region Skåne
  More Information

Publications:

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03122795     History of Changes
Other Study ID Numbers: Snortransplantationsstudie1
First Submitted: April 18, 2017
First Posted: April 21, 2017
Last Update Posted: June 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be presented at group level for personal integrity reasons.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes