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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
April 18, 2017
April 21, 2017
June 14, 2017
May 15, 2017
August 30, 2018   (Final data collection date for primary outcome measure)
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
SNOT-22 [ Time Frame: Day 1 to day 106 ]
Change of burden of disease as measured by the SNOT-22 questionnaire in patients
Complete list of historical versions of study NCT03122795 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 culturedependant and non culturedependant microbiological techniques.
Not Provided
Not Provided
 
Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

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.

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.

Interventional
Not Provided
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
Chronic Rhinosinusitis (Diagnosis)
Procedure: Microbiome transplant
A raw microbiome, collected from a donor without any sinonasal health problems, as a nasal lavage.
Experimental: Microbiome transplant
The only arm of the study. Patients suffering from CRSsNP gets microbiome transplants from donors without any sinonasal health problems.
Intervention: Procedure: Microbiome transplant

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 31, 2018
August 30, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Anders Mårtensson, MD +46768617200 anders.s.martensson@skane.se
Contact: Anders Cervin, MD PhD +61467980662 acervin@me.com
Sweden
 
 
NCT03122795
Snortransplantationsstudie1
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Data will be presented at group level for personal integrity reasons.
Region Skane
Region Skane
Not Provided
Principal Investigator: Anders Mårtensson, MD Region Skåne
Region Skane
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP