Trial status
The approved protocol with amendment number 4 was issued on 28 June 2022. The first patient was included on 01 September 2022. The study is currently recruiting patients. Estimated date of completion (last patient’s last follow-up): 01 November 2023.
Ethical statement
This study is conducted in accordance with the Helsinki declaration (62). All patients receive, as a minimum, established standard medical care according to National clinical guidelines (42). In the study, we compare two organisational care pathways, i.e., a geriatric team assessment and the care of the attending team. No patients will be exposed to any project-related risk or experimental treatments. Participants may decline parts of or the entire intervention at any time. Because no experimental treatments are applied and no biological data are collected, the study is categorised as quality improvement and therefore liable to approval from the board of directors at Aarhus University Hospital. Approval was obtained 14 March 2021. The study design and its categorisation as quality improvement was approved by the Central Denmark Region Committees on Health Research Ethics (j.no. 1-10-72-1-21, 2 February 2021). On publication, only anonymised and summarising data will be presented.
Permission to assess and transmit personal data from the EMRs relevant for quality improvement for patients with CDI, was obtained the hospital boards at Aarhus University Hospital and all attending regional hospitals in CDR. CD tests, conducted at Department of Clinical Microbiology AUH, are a part of the EMRs. Thus, permission to access the microbiological lists by project manager was granted via same permission. The CDR is the data protection responsible part. Personal data from the EMRs for quality improvement are transferred to the research project at Aarhus University with legal basis in the law, the Data Protection Act §10. Data will be managed via REDCap according to cooperation agreement between Aarhus University and the CDR.
By Danish law, consent to routine clinical treatment is given by oral and not written consent. All examinations and treatments in the study are conducted according to routine clinical practice and following obtaining informed oral consent, as required by Danish Health Authority, Danish law. In patients without the capacity to provide oral consent, consent is given on behalf of the patient by a next of kin. All patients in the study are contacted by the geriatric team at 12 weeks of follow-up and, oral consent to perform QoL and functional status assessments is obtained and documented in the EMRs.
FMT treatment is provided following informed written consent, using a standardised FMT consent form (Additional file 9). The patient’s consent concerns permission for record access and data storage to allow full traceability according to the Tissue Act. Before FMT, the patient is informed orally and with a written information leaflet about the effect and possible side effects.
Consent for publication
No personal information is published.
Availability of data and materials
No study data are available at the protocol stage of the project process. Code book for data entry databases and all other project-related raw material are available upon reasonable request to the corresponding author.
Competing interests
The authors declare that they have no competing interests.
Funding
This work is sponsored by Department of Geriatrics, Aarhus University Hospital and supported by Health Research Foundation of Central Denmark Region (grant number A2778) and Helsefonden (grant number 22-B-0239). The FMT framework is supported by an investment from Innovation Fund Denmark (j.no. 8056-00006B). Christian Lodberg Hvas has received project funding from Novo Nordisk Foundation (j.no. NNF22OC0074080). The design, management, analysis and reporting of the study are entirely independent of the funding sources.
Authors’ contributions
TR*, HV*, MG*, MA*, IB*, JJ*, MR*, JR*, MØ*, RV*, CK*, CS*, SB*, CH* and ED* contributed in design and planning of the study and have critically revised the manuscript. HV, RV and CS contributed in developing patient material. MG and CS provided statistical expertise. TR is responsible for the daily running of the study, data collection and wrote the manuscript. All authors have approved the final manuscript. The authors follow the ICMJE authorship guidelines. There was no use of professional writers.
*Tone Rubak (TR), Hanne Veilbæk (HV), Merete Gregersen (MG), Malene Asferg (MA), Ishay Barat (IB), Joanna Secher Johnsen (JJ), Mikael Groth Riis (MR), Jeppe Rosenbæk (JR), Marianne Ørum (MØ), Rita Stockholm Vinding (RV), Carl Aksel Kragh Sørensen (CK), Claire J Steves (CS), Simon Mark Dahl Baunwall(SB), Christian Lodberg Hvas (CH), Else Marie Skjøde Damsgaard (ED)
Acknowledgements
The authors thank all participating centres and patient representatives.