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КЛИНИЧЕСКИЕ ИСПЫТАНИЯ - 2007: Клиника AZ_LOKEREN, (Бельгия) - англ.версия

30.11.2018 09:25
  Chrisal N.V.    Lommel (Producer/ Project responsible) 
  Ghent University  Gent  (Microbiological analyses) 
  Avecom N.V.  Gent  (Consultancy and data reviewing) 
  A.Z. Lokeren  Lokeren (Trial hospital) 
Dr. Robin Temmerman  Robin@chrisal.be 0496/27.41.10 Corrie Gielen Corrie@chrisal.be 0497/58.91.06 
Prof. Willy Verstraete  Willy.Verstraete@ugent.be    09/264.59.76 
Dr. ir. Wim De Windt Wim.Dewindt@avecom.be  0473/61.46.36 
AZ Lokeren 
Koen Van Landeghem  Koen.van.landeghem@azlokeren.be  09/340.83.86 
 The intense use of disinfectants and antibiotics in hospitals has resulted in a number of highly resistant micro-organisms, which become increasingly involved in nosocomial infections of patients. Especially Methicillin Resistant Staphylococcus Aureus (MRSA) and Clostridium are currently a huge problem in hospitals, causing severe illness and death among hospital residents. The currently used cleaning products and disinfectants are no longer effective in removing these and other (opportunistic) pathogens from hospitals.  
 Chrisal, expert company in microbiological cleaning has developed a new range of cleaning products, based on probiotic bacteria (Probiotics In Progress - PIP). In cooperation with Ghent University, Avecom and the AZ Lokeren hospital, the company wanted to verify whether these products provide an efficient alternative to ‘regular’ cleaning and disinfection products in a hospital environment. After a preliminary test case in the utility rooms of the AZ Lokeren hospital (September 2006), this large scale study had to demonstrate that these new PIP Healthcare® products are indeed capable of managing problems with (opportunistic) pathogens, especially MRSA and Clostridium. The concept of PIP is that of microbial management, aiming at a healthy and stable microbial community, instead of absolute and unconditional sterility.  
 In this study, during PHASE 1, a complete level of the AZ Lokeren hospital was cleaned for 1 month with Chrisal’s PIP Healthcare products and microbiologically monitored by Ghent University and Avecom. Comparison was made with the regular cleaning and disinfection procedures.   During PHASE 2, nearly the complete AZ Lokeren hospital was cleaned with PIP Healthcare products; again with comparison to regular cleaning and disinfection at control Floors.  
 This report provides information on the prevalence of several bacterial groups in a hospital environment and clearly demonstrates the high efficiency of Chrisal’s PIP Healthcare products to manage pathogenic hospital bacteria. 
The report contains the following chapters: 
- PART 1: Project description o  Product information: concept, safety, product range o  Study protocol: location, cleaning procedure, microbiological analyses, patient monitoring 
- PART 2: Project results – PHASE 1 - PART 3: Project results – PHASE 2 
- PART 3: Conclusions 
1. Product information  
 This part of the report provides a brief overview of the general concept of microbiological cleaning, as developed by the company Chrisal. The mode of action and safety of the PIP products, their advantages over disinfection, as well as an overview of the products used during this study is presented.  
a. Concept  
 A broad range of pathogenic (= disease causing) micro-organisms cause numerous health problems to humans and animals. Some examples are for instance Campylobacter, Candida, Clostridium, E. coli, Legionella, Listeria (Fig 1), Salmonella, Staphylococcus (MRSA) and Streptococcus. In addition to the dangers induced by these organisms in each of our personal environment, they are also responsible for a large number of economic losses due to increased animal mortality (breeding programs), reduced productivity (food industry) and increased health care costs (hospital bacterium, dust mite). Using antibiotics and disinfectants, these problems could easily be managed during the past decades. However, the past years a rapidly increasing resistance 
 against these ‘miracle agents’ has been noticed in all Fig 1. A pathogenic Listeria. sectors, to such an extent that a radical new approach is eminent. 
healthcare industry because of their health promoting properties to humans and animals. By means of extensive research and validation Fig 2. 
Probiotic PIP bacteria 
 By the creation of the PIP (Probiotics In Progress) products, Chrisal offers an innovative and sustainable solution to resistance problems. These products rely on the concept of ‘microbial management’, in which no longer complete sterile environments are desired, but a stable and healthy microbial community is created. This can be achieved by means of probiotic micro-organisms (Fig. 2). These are safe and useful bacteria or yeasts that are already known and exploited for years in food and 
tests, Chrisal succeeded in applying this probiotic concept to environmental applications. All PIP products contain probiotic bacteria as a crucial ingredient, which possess the unique property of sporulation. This process makes it possible for these bacteria to survive harsh conditions and regain their activity as soon as environmental parameters improve. Without this feature it would be impossible to implement probiotics into cleaning products for environmental or industrial process applications.  
Mode of action: Competitive exclusion and quorum sensing 
 Bacteria, especially pathogens, have a strong tendency to develop resistance to any substance that might be detrimental or lethal to them. This phenomenon is currently flagrant in case of antibiotics and disinfectants. In order to avoid such resistance development, none of the PIP products has any direct biocidal action towards other organisms. The mechanism of action is based on the principle of ‘competitive exclusion’, combined with an influence on the ‘quorum sensing’ communication between pathogenic organisms. 
 Especially in case of disinfectants, an important disadvantage is the unspecific action of these agents, killing both good and bad micro-organisms. This results in an open surface, subject to fast recolonisation by (pathogenic) bacteria. Hence, disinfection results in a fast but short and unstable reduction of the number of micro-organisms. Because of the current resistance problems, continuously increasing concentrations and frequencies of disinfectant have to be applied, which is very detrimental to humans and the environment because of their aggressive chemical nature. 
Why are these problems not relevant to the probiotic PIP products?  
 The idea behind competitive exclusion is that during the cleaning procedure a layer of probiotic bacteria is placed on the treated surface, immediately occupying the ‘field’ by good bacteria. They will consume all remaining food sources (incl. dead organic matter by means of necrotrophy), leaving nothing behind for potential pathogenic invaders looking for space and food. The probiotic PIP bacteria are extremely efficient and outdo all other (pathogenic) bacteria. Additional to competitive exclusion, also quorum sensing between pathogenic bacteria is influenced. This is an extremely fast way of communication between bacteria, making use of signal molecules. When the probiotic PIP bacteria are applied to a surface, this immediately results in the fact that pathogenic bacteria, by means of quorum sensing, will inform each other about these unfavourable condition, turning them into an inactive metabolic state. 
 The PIP approach has the main advantage that it provides a stable solution to problems with pathogens, without any resistance build-up. The only demand set by this method is that the frequency of cleaning is kept constant, which is already evident for any hospital environment. After PIP cleaning, the total number of micro-organisms on the surface will not necessarily be higher; the good bacteria simply replace the bad ones.  
The following table presents a conclusive comparison between disinfection and PIP cleaning:  
           Disinfection    PIP cleaning 
- 50/50 ratio of good/bad bacteria + 95/5 ratio of good/bad bacteria 
- short effect (unstable effect) + long lasting effect (stable effect) 
- resistance problems  + no resistance possible 
- detrimental / unsafe products  + harmless / safe products 
- chemical / environment unfriendly + biological / environment friendly 
- aggressive + neutral 
b. Safety aspects 
PIP products are completely safe to use for several reasons: 
- The probiotic bacteria used in the PIP products are members of the genus Bacillus and belong to biosafety class 1, as listed by the American Type Culture Collection (ATCC). The following table presents all four biosafety classes: 
Class Description Risc 
1 Non-pathogenic micro-organisms  None 
2 Micro-organisms and parasites that may cause disease, but with an unlikely spread and for which efficient prophylaxis or treatment exists. Low 
3 Micro-organisms and parasites that are able to spread and cause disease, but subjective to efficient prophylaxis or treatment  Average 
4 Micro-organisms and parasietes with large scale spreading and serious illness, for which no prophylaxis or treatment exists. High 
- A number of probiotic Bacillus species have been granted the GRAS (Generally Recognized As Safe) label by the Food and Drug Administration (FDA) and can as such be used for human purposes without any hazard. 
- The PIP bacteria belong to the group of sporulating probiotics, of which over hundred commercial pharmaceutical and nutritional products are available for human oral consumption. A regular dose of these preparations is 10 billion bacteria per day, which is about 10.000x more concentrated than the PIP products. 
- Additional to the safety classification by ATCC, the producer of our bacterial strains performed a large number of toxicity tests to guarantee the safety of our bacteria. No single toxic effect from our Bacillus strains was measured.  
- Chrisal itself performed multiple safety tests in collaboration with external and accredited laboratories. All PIP products are certified as safe to use. 
- In view of antibiotic resistance, Bacillus strains are Gram-positive organisms, which have much less tendency to develop, acquire or transfer antibiotic resistance. Although certain Bacillus strains are intrinsically resistant to certain cephalosporin, macrolide and quinolone antibiotics, from scientific literature, it can be concluded that at this moment, no Bacillus strains are known to transfer this antibiotic resistance to other organisms, neither in vitro nor in vivo. 
- Members of the genus Bacillus are used intensively in different kinds of industries because of their high enzyme production capacity. Examples are washing powders, waste water treatment, food preservation… 
 In conclusion, the probiotic PIP bacteria are perfectly safe to use. These organisms have been officially classified as save organisms and have been used for decades without any negative effect. Although during the course of this study patients did not come into contact with the cleaning products themselves, a direct contact with the PIP bacteria was possible through the treated surfaces. Given the fact that the PIP bacteria replace pathogenic bacteria, the only result of a patient’s contact with these surfaces is a lower chance of contact with pathogens.  
c. Product range 
During the course of this study, the following PIP Healthcare® products were used: 
PIP Floor Cleaner NFG: This floor cleaner is a probiotic bacteria containing product, with a neutral composition suitable for all kinds of floors. The chemical composition is consultable in the MSDS file on demand; the number of probiotic bacteria is 30 million CFU/ml, with a dilution factor depending on the type of application (average of 2%). Dilution has to be done using water of approximately 40°C. 
PIP Universal Cleaner: This product has a neutral composition, making it suitable for all kinds of materials and surfaces. The chemical composition is again available through the MSDS file on demand; the bacterial composition is equal to the above mentioned Floor Cleaner. 
PIP Sanitary Cleaner: This cleaner is suitable for all kinds of sanitary installations and contains a higher concentration of probiotic PIP bacteria. This in order to compensate for the increased washout because of the running water in the installation. The bacterial concentration of the sanitary cleaner totals 50 million CFU/ml. 
PIP Allergy Free: This product has been developed to render any kind of textile free of pathogenic bacteria, as well as dust mite allergens. The product contains 50 million CFU/ml of PIP bacteria and has to be sprayed on the textile during 3 seconds. 
 The formulation and dilution factors for each of the above products have been calculated in such a way that the final concentration of probiotic bacteria on the treated surfaces equals as much as possible the concentration of residual micro-organisms before application. By means of precision pumps mounted on the cans, a reproducible dosage could be obtained throughout the study.  
2. Study protocol 
 The study, reported in this document, followed on a preliminary test that was carried out in September 2006 to verify the potential of the PIP Healthcare® products for microbiological cleaning of a clinical environment. That test provided such positive results that it was immediately decided to perform a large scale study in order to demonstrate the efficiency of the PIP products, compared to classical cleaning procedures.  
 Because this study also implied the cleaning of patient rooms, the ethics committee (Registration Number 0G217) of the AZ Lokeren hospital had to approve this study, which was done on the 9th of January 2007, after carefully evaluating the dossier. This study has been granted the following Clinical Trial Number: B2652006814 
The overall study presented in this report comprises two phases: 
- PHASE 1: Instead of one utility room, the entire third Floor of the AZ Lokeren hospital was treated with Chrisal’s PIP products and compared to the first Floor, harbouring an equal patient type. 
- PHASE 2: Following the first Phase, a buffer period of one month with overall regular cleaning was inserted. Subsequently, the entire hospital was cleaned with the PIP products, except for the third Floor now serving as a control.  
The next part of this report provides an overview of the study protocol, addressing the following items: 
Location: information on AZ Lokeren, trial hospital for this study 
Cleaning schedule: according to which time schedule and hygienic guidelines was cleaned during the course of this study. 
Microbial analyses: which micro-organisms were screened for and which sampling procedure was applied. 
Patient monitoring: How were patients monitored during the course of the study? 
Report: How were the results interpreted and processed into this report. 
a. Trial hospital: AZ Lokeren 
 The general hospital of Lokeren (AZ Lokeren) is a regional hospital providing a broad range of healthcare services to the 37.500 inhabitants of Lokeren itself, as well as the surrounding communities. Since January 2005, AZ Lokeren is also an active partner of the university hospital of Ghent. The hospital has a capacity of 170 beds, with a staff of 350, of which 50 physicians. 
The following divisions and services are available at the hospital: 
- Surgery 
- Intensive and medium care 
- Internal medicine 
- Maternity 
- Paediatrics 
- Day care 
- Emergency unit 
- Medical laboratory 
- Medical imagery 
- Palliative care 
 Phase 1 of the study was performed at the 1st and 3rd Floor of the hospital, which harbour the internal medicine department. Both floors have a capacity of 31 beds for patients suffering from diseases of the heart, digestive tract, longs, joints, skin and illnesses such as diabetes. Because of the same kind of patients on both Floors, the microbiological load is assumed to be similar and representative for this study. This was already verified during the preliminary study and the microbiological analyses preceding the actual trial. 
 During phase 2, nearly the entire hospital was subjected to PIP cleaning, comprising different pathologies and patient types. This facilitated the evaluation of PIP cleaning under different microbiological loads. 
b. Cleaning schedule 
During PHASE 1 of this study, two similar floors (geriatrics) of the AZ Lokeren hospital were chosen:  
- The 1st floor served as control, with regular cleaning.  
- The 3rd floor was subjected to PIP cleaning.  
During PHASE 2 of the study, after one month of overall regular cleaning, PIP cleaning was expanded: 
- The 3rd floor served as control  
- The rest of the hospital was subjected to PIP cleaning [excl. Operation units 
(completely) and Intensive Care, Maternity, Radiology (only the floor was PIP cleaned)] 
 Although not presented in detail, cleaning schedules as designed by AZ Lokeren were identical for all Floors and remained unaltered during the course of the study. Only a replacement of the regular products by PIP Healthcare® products was done; except for those on the control Floor. By means of precision pumps mounted on the cans, a reproducible dosage could be obtained throughout the study. 
- On weekdays the complete Floor was cleaned following a strict schedule. All floors, sanitary and furniture were cleaned.  
- During weekends, only patient rooms were cleaned completely following the weekday schedule. Central hall and general areas were not cleaned. 
 Special cleaning protocols exist for contaminated rooms (e.g. hepatitis, MRSA,…), mostly describing a disinfection step each day of the patients stay, followed by a thorough disinfection of all surfaces and furniture in these rooms after discharge of the patient. Although Chrisal’s PIP products have been developed as an alternative to disinfectants, the ethics committee decided not to omit disinfection protocols in case of contaminated patients. Although encountered with low frequency, each disinfection step that occurred during the study was registered.  
 The most important aspect of this study is that