Stool Sampling in the Acute Isolated Patient, Efficient Acquiring With a Novel Device
Phase: NA
Conditions: Feasibility Study
Sponsor: Zealand University Hospital

Stool samples – 
Efficient sampling 
Protocol overview 
Project title Stool samples - efficient sampling 
Clinical trial design 
Proof of concept 
Timetable 
November 2020 – December 2023 
Purpose 
Testing of collection tubes for stool samples 
Number of patients 
50 
Latest approval sep 14 2022 
 
Summary 
Several patients are admitted to the Oncology ward O81 and the medical department SUH, 
Køge (here primarily to rule out infectious diarrhea) with thin stools/diarrhea, which can be 
both chemo-induced and infectious and thus require isolation. 
Patients who need to have a stool sample taken for microbiological examination risk receiving 
relevant treatment later if they cannot separate urine and stool. By waiting for a usable stool 
sample, the patient risks being hospitalized for a longer period of time and receiving relevant 
treatment with antibiotics or antidiarrheal agents later. In addition, there is a risk that any 
infection will be spread to other patients on the ward. 
By developing a collection tube, the patient can have a stool sample taken upon arrival at the 
department and then receive relevant treatment when there is a response from the 
Microbiology Department. Resources can be saved on both isolation remedies and personnel 
if the patient is not diagnosed with a diagnosis requiring isolation. 
In addition to the above, there is also the hygienic aspect that with the current remedies 
available, the staff must collect the stool sample from a basin and put it into a test tube that 
can be sent to the Microbiology Department. With the collection tube, it is possible to take the 
sample directly from the rectum. 
With the completion of this study, it is expected that patients admitted with loose 
stools/diarrhea will be diagnosed more quickly and thus receive relevant treatment more 
quickly. This may lead to a shorter hospitalization period and savings on the resources that 
Zealand University Hospital uses on medicine, isolation measures and personnel. 

The above method can be expected to be extended to other specialties than just oncology, as 
well as to the primary sector. 
Background 
Clinically, diarrhea is defined as three or more loose stools per day or an increased volume of 
stool (over 200 grams) per day. Diarrhea is divided into acute diarrhea, lasting less than two 
weeks, and chronic diarrhea, lasting more than two weeks. Diarrhea is defined based on the 
consistency, amount, appearance, and frequency of the stool [1] 
Problem statement 
Patients admitted with loose stools/diarrhea must be diagnosed quickly so that relevant 
treatment can be initiated. The current workflow of collecting stool samples from the pelvis 
without adding urine can extend the time to diagnosis and thus the hospitalization process, 
with the consequence that the patient will receive relevant treatment later. 
Hypothesis 
With a collection tube that can be easily inserted into the rectum, the time to collect the first 
usable stool sample will be shortened. 
Purpose 
Testing of collection tubes for stool samples. 
Design 
Proof of concept study, where the collection tube is tested on 50 hospitalized patients on 
Oncology Ward O81. 
Inclusion criteria 
• 
The patient must be at least 18 years old. 
• 
The patient must be able to understand Danish 
• 
All patients admitted to the Oncology ward O81 with loose stools/diarrhea. This 
is regardless of whether the patient is undergoing active medical cancer treatment and/or 
antibiotic treatment. 
• 
It is a requirement that the patient is cognitively well-functioning and can 
understand the patient information related to the study. 
• 
The patient must be able to cooperate optimally with the sampling itself. If this is 
not assessed at the time of admission, the patient will be excluded from the study. 
 

Exclusion criteria 
• 
Expected remaining life < 2 weeks 
Recruitment 
All patients admitted with loose stools/diarrhea will be offered the opportunity to participate 
in the study. They will be selected if they meet the inclusion criteria described above. 
Procedures 
Patients admitted with loose stools/diarrhea will have a stool sample taken with the collection 
tube at the time of admission. 
The patient is placed on their side in a bed or on a stretcher before the actual sample 
collection. 
The stool sample is then sent to the Microbiology Department for standard testing for 
Clostridium Difficile, pathogenic intestinal bacteria and viruses. No other analyses are 
performed and only the actual collection of the stool sample is included in the project. The 
stool sample taken with the collection tube replaces the stool sample with the standard 
method. 
Method 
In the current workflow for collecting stool samples, the patient must sign off with a stool 
sample on a basin. The stool must not be mixed with urine. The stool is then collected in a 
clear plastic container. A small spoon is attached to the brown lid of the plastic container and 
this is used to collect the stool in the plastic container. The lid is then screwed firmly onto the 
plastic container and it is marked with the patient's name and social security number from 
the PTB note. The plastic container is placed in the associated protective sleeve and sent for 
cultivation and resistance testing at the Microbiology Department. 
If multiple samples are taken for the same examination, these must be taken from different 
stools, and if multiple samples are taken for different examinations, these can be taken from 
the same stool. 
The method to be investigated in this study is the insertion of a collection tube into the 
rectum. The tube is passed 10 cm up the intestine. Then a spiral inside the collection tube is 
turned around and stool is collected in the tube, which is subsequently removed from the 
intestine again. The stool sample is now sealed inside the collection tube and the collection 
tube is marked with the patient's name and social security number from the PTB note. The 
collection tube is sent for culture and resistance determination at the Microbiology 
Department. 
Experimental conditions: the subjects do not need to be specially prepared for the collection. 

Microbiological analysis: cultivation and resistance testing of bacteria and viruses in stool 
samples. An amount of stool the size of a large pea or approximately 2 ml is used. 
Static considerations 
Since this is a proof -of -concept study and the results can only be divided into either 
successful or unsuccessful, 50 patients are considered a suitable number. No statistical 
calculation has been performed. 
Timetable 
Project start date: 01.11.20 
Project end date: 31.06.23 
Place 
The study takes place at the Oncology Ward O81, Zealand University Hospital (SUH), Roskilde 
and the Medical Ward SUH, Køge. 
Practical options 
A patient room, bed or bed, collection tube, office facilities with access to the Health Platform 
must be used. 
Rights 
Nurse Anne-Dorte Krapper will be responsible for collecting and storing data supervised by 
professor, senior physician Jørn Herrstedt. 
Research engineer Anders Ohlhues Baandrup will be responsible for the contact with the 
company that will produce the collection tube, and will be kept informed about the study. 
Chief physician, clinical associate professor, PhD Lasse Bremholm Hansen will supervise the 
collection method itself and will be continuously informed about the study. 
Anne-Dorte Krapper will introduce nursing staff on the wards to the study so that they can 
participate to a certain extent in the collection of stool samples. 
 
 
Ethics 
It is estimated that there will be no additional inconvenience for patients who have a stool 
sample taken with the collection tube compared to the inconvenience of the standard 
method. There will be no additional attendances, as all patients are already hospitalized with 
diarrhea. 

It will take less time to complete the questionnaire. 
The study will be submitted to the Danish Medicines Agency, the Regional Scientific Ethics 
Committee and data notification to Region Zealand and will not be initiated until relevant 
approvals are available. 
Information and consent 
Patients included in the study will be informed verbally about the study at the time of 
admission and will be given written patient information about the purpose of the study. In this 
connection, the patient's immediate consent to participate in the study will be obtained. 
The patient's consent gives the trial director, sponsor and sponsor's representatives, as well 
as any supervisory authority, direct access to obtain information in the patient's medical 
record, etc., including electronic medical records, in order to view information about the 
subject's health conditions, which is necessary as part of the implementation of the research 
project and for control purposes, including self-control, quality control and monitoring, which 
they are obliged to perform. 
Data 
Data is entered into Excel. 
Data storage 
Data is stored in pseudonymized form on PC, as all patients are assigned an allocation 
number. The allocation number ensures that no personally identifiable data is stored on PC. 
Backup files are placed in a locked filing cabinet in the department management office, and 
can be used to identify the patient. 
Data will be stored in accordance with applicable regulations for trials, and destroyed 
thereafter. 
The following patient data is collected: 
Age, gender, cancer diagnosis, temperature ( > 38.5), neutrophil count (< 0.5 x 10 9 /l), number 
of bowel movements in the last 24 hours, possible constipation in the last 24 hours, date of 
last series and type of medical cancer treatment (if applicable), date of hospitalization, date 
of stool sample and results of stool sample. 
The above patient record information must be used to ensure that these are relevant patients 
in terms of being hospitalized with infectious diarrhea, as well as to describe demographics 
and any comorbidity. 
The information that will be used in the project before consent is given from the subjects is 
passed on to the researcher. 

The experiment has been registered with Region Zealand and is subject to the Data Protection 
Act and the General Data Protection Regulation . 
 
Economy 
The study is supported by the Department of Clinical Oncology and the Innovation and 
Technology Council at Zealand University Hospital with Match Point funding of DKK 100,000. 
MatchPoint is a project under Zealand University Hospital, where innovation projects, after a 
professional assessment, are financially supported with DKK 100,000 for development and 
testing. 
MatchPoint funds: DKK 100,000. 
The above has financed the development of collection tubes, patent search and salaries. 
Funding: the experimental group has received an Inno Explorer grant, funding the study. 
There are no affiliations with any companies with an interest in the trial, among any of the 
participants in the trial group. The study is part of a product development, and there is no 
product on the market at present. A number of prototypes will be manufactured, paid for by 
the trial group, with funds from MatchPoint allocated to the group. 
The research group has no financial interest in the study, but wishes to patent the invention. 
Recruitment of subjects and informed consent 
The subjects are recruited at the time of admission when the doctor records the admission 
record and prescribes that stool samples be taken for culture and resistance testing. The 
patient will be isolated and will thus be alone in a patient room, so that oral information and 
conversation about the study and its rationale can take place undisturbed. Written patient 
information will be provided. 
The right to an assistant will be offered when a potential candidate for the study is identified. 
Since the purpose of the study is a quick and efficient collection of stool from the rectum, 
where we have the opportunity to reduce the time in isolation, we want the reflection time to 
be reduced as much as possible, preferably to 1-2 hours, and since the experiment is 
considered completely harmless and will not impair treatment, this is considered reasonable. 
The patient's immediate consent to participate in the study is obtained as soon as a 
prescription from a doctor is available and the patient has given his consent after a period of 
reflection. 
Publication of results 

As it is a proof of concept study, the results will be used to develop a larger study. 
Trial results of both positive, negative and inconclusive grades will be published. 
 
Administrative matters 
• 
Notification/approval to the Danish Medicines Agency 
• 
Notification/approval to the Regional Research Ethics Committee 
• 
Data notification/approval to Region Zealand 
• 
Security 
• 
Insurance: Patients are covered by the hospital's general patient insurance. 
• 
Division of responsibilities 
• 
Publication – journal 
Reference list 
Fernández-Bañares F. et al: æChronic diarrhoea : Definition, classification and diagnosis. 
Elsevier, Gastroenterol Hepatol . 2016;39(8): 535-559 
Layman's summary 
The purpose of this study is to collect a stool sample from the patient who is admitted with 
loose stools/diarrhea, already at the time of admission. 
The study is not considered to be associated with any risks or disadvantages for the patients 
who participate.