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Pilot study: Respiratory microbiome analysis by the IS-pro technology.


- candidate number22767
- NTR NumberNTR5369
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-aug-2015
- Secondary IDsNL49157.068.14 
- Public TitlePilot study: Respiratory microbiome analysis by the IS-pro technology.
- Scientific TitlePilot study: Respiratory microbiome analysis by the IS-pro technology. The Maastricht Respiratory Microbiome Study.
- ACRONYMMaastricht Respiratory Microbiome Study (MRMS)
- hypothesisIt is expected that the respiratory microbiome will be relatively stable over time in non-infectious patients.
- Healt Condition(s) or Problem(s) studiedCOPD, Bacterie, Virus
- Inclusion criteriaIn order to be eligible to participate in the study, a patient must meet all of the following criteria:
• Diagnosis of COPD stages I-IV, class A-D, as defined by the Global initiative for chronic Obstructive Lung Disease (GOLD)23;
• Patients must be planned to undergo a bronchoscopy;
• Patients must be able to complete questionnaires;
• Patients must sign and date an informed consent prior to inclusion.
- Exclusion criteriaA patient who meets any of the following criteria will be excluded from participation in this study:
• Chronic use of oral corticosteroids > 10 mg/day;
• Investigator’s uncertainty about the willingness or ability of the subject to comply with the protocol requirements, e.g. not smoking 6 hours before and fasting two hours before sputum induction;
• Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study;
• Patients unlikely to comply with the protocol, e.g. uncooperative attitude, and unlikelihood of completing the study (not able to attend all three visits).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 24-aug-2015
- planned closingdate1-jun-2016
- Target number of participants20
- InterventionsNose swab
Throat swab
Sputum
Bronchial aspirate
Mini-BAL
- Primary outcomeTo determine the optimal sample type for respiratory microbiome analysis using the IS-pro technology.
- Secondary outcome1. Intra-patient analysis to define and compare the respiratory microbiome and its microbial diversity by BAL fluid, bronchial aspirate, induced sputum samples, throat and nose swabs;
2. Longitudinal analysis of respiratory microbiome in sputum, throat and nose swabs, to assess the respiratory microbiome and the microbial diversity of patients over time, between the same and different sample types.
- TimepointsBaseline (visit 1)
Visit 2 (1/2 weeks after visit 1)
Visit 3 (half year after visit 1)
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Dionne Braeken
- CONTACT for SCIENTIFIC QUERIESDr. G. Rohde
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Microbiome Ltd. & IS Diagnostics
- Publications
- Brief summaryThe human microbiome has gained interest in health and disease. For a long time, it was believed that the lungs of healthy individuals were sterile. More recently, it was shown that the lungs of both healthy individuals and diseased patients consisted of a rich respiratory microbiome, even in the absence of symptoms of an infection. Until now, different sampling methods have been used for respiratory microbiome analyses, including both invasive as well as non-invasive techniques. In addition, different technologies were applied, with the interspace-region-based profiling (IS-pro) method as a new technology tested on the intestinal microbiome. Until now, no lung samples have been tested by the IS-pro technology, although this technology has some advantages over next-generation sequencing. Research showed that IS-profiling is highly reproducible, fast and easy to perform and suitable for high-throughput profiling of the human intestinal microbiome. Therefore, the IS-pro technology is more readily adoptable to routine diagnostics compared to next-generation sequencing.
- Main changes (audit trail)
- RECORD20-aug-2015 - 12-feb-2017


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