Can taking probiotics ('friendly' bacteria) reduce upper respiratory tract infections in healthcare workers?

ISRCTN ISRCTN90136957
DOI https://doi.org/10.1186/ISRCTN90136957
Secondary identifying numbers PROBINS 8.1
Submission date
30/03/2020
Registration date
02/04/2020
Last edited
15/05/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Probiotics are ‘friendly bacteria’ that can have beneficial effects by, amongst other ways, interacting with the bacteria that already live in the gut to promote a healthy gut microbiota that supports the well-being of the host. The aim of this study is to see if the daily consumption of a probiotic supplement will modulate the functioning of the gut microbiota resulting in the reduced incidence and/or duration of Upper Respiratory Tract Infection (URTI, also known as the common cold), and improve quality of life and wellbeing in healthcare workers (who are prone to infections from exposure to "unwell individuals").

Who can participate?
Adults aged between 18 to 70 years working in a healthcare setting i.e. nurse, doctor, pharmacist, health-care porter.

What does the study involve?
Participants will be asked to take one capsule containing either the active product (probiotic) or an identical inactive product (placebo) every day for 4 months (112 days). There is an equal chance that the participant will be assigned to take the active or placebo and neither the participant themselves nor the study researchers will know who is taking what.

Participants complete a daily diary indicating if they are experiencing any cold-like symptoms (coughing, sneezing and blocked nose). Participants will complete a questionnaire assessing the general quality of life, well-being and health at 0, 2 and 4 months. Blood pressure, body weight and peak flow (how well your lungs are functioning) will be measured at the start and end of the study. Blood and saliva samples at 0 and 4 months and from volunteers, stool (faecal) and urine samples at 0 and 4 months.

What are the possible benefits and risks of participating?
It is hoped that the results from this work will lead to improvements in our understanding of the benefits of taking probiotics and those participants receiving the probiotic might experience reduced symptoms.
There have been no adverse reactions associated with the consumption of Lab4 probiotics. but mild side effects such as a change in bowel habit and/or increased flatulence may occur during the first few days of taking the supplement.

Where is the study run from?
The University Clinic of Pulmonology and Allergology, Saints Cyril and Methodius University of Skopje (Macedonia)

When is the study starting and how long is it expected to run for?
December 2017 until April 2018

Who is funding the study?
Cultech Ltd (UK)

Who is the main contact?
Dr Sue Plummer, suep@cultech.co.uk

Contact information

Dr Daryn Michael
Scientific

Cultech Ltd
Unit 2 Christchurch Road
Baglan Industrial Estate
Port Talbot
SA12 7BZ
United Kingdom

ORCiD logoORCID ID 0000-0001-8546-1153
Phone +44 (0)1639 825100
Email darynm@cultech.co.uk

Study information

Study designSingle-centre randomised double-blind placebo-controlled parallel-group study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request participant information sheet
Scientific titlePROBiotics for the prevention of Upper Respiratory Tract INfectionS in healthcare workers
Study acronymPROBINS
Study objectivesDaily supplementation with Lab4 probiotics will reduce the incidence and/or duration of Upper Respiratory Tract Infections (URTI) and improve quality of life and general wellbeing in health care workers.
Ethics approval(s)Approved 20/02/2017, Ethics Committee for Clinical and Other Investigations related to Medicines and Medical Supplies within the Agency for Medicines and Medical Supplies of the Republic of Macedonia (St. Styril and Methodius 6g.S4 floor: t, Skopje, Macedonia; +389 (0)2 5112 394; email not available), ref: 11-372/1
Health condition(s) or problem(s) studiedUpper respiratory tract infection
InterventionThe active product: a capsule containing the Lab4 probiotic consortium (Lactobacillus acidophilus CUL-60 (NCIMB 30157), Lactobacillus acidophilus CUL-21 (NCIMB 30156), Bifidobacterium bifidum CUL-20 (NCIMB 30153) and Bifidobacterium animalis subsp lactis CUL-34 (NCIMB 30172)) at a total of 5 x 10^10 (50 billion) colony forming units (cfus) per day. The placebo: an identical looking capsule containing microcrystalline cellulose and maltodextrin.

Trial subjects were allocated in a 1:1 ratio into two parallel study arms (active arm or placebo arm) according to a randomisation protocol provided by an independent statistician. The intervention period was 16 weeks (112 days).
Intervention typeSupplement
Primary outcome measureIncidence and duration of URTI symptoms (Patient records at 4 months)
Secondary outcome measures1. Incidence and duration of absence from work, antibiotic usage and visits to general practitioners (Daily records)
2. General well-being and health assessed (Quality of life questionnaire; 0, 2, 4 months)
3. Microbiota composition/functionality. (Traditional and NGS; 0, 4 months)
4. Bodyweight, blood pressure and peak flow (0, 2, 4 months)
5. Analysis of biomarkers in blood/urine/saliva (0, 4 months)*
*The methods of analysis for blood/urine/saliva have yet to be finalised
Overall study start date10/01/2017
Completion date12/04/2018

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants104
Total final enrolment104
Key inclusion criteria1. Male or Female aged between 18 and 70 years
2. Must work in a health-care setting
Key exclusion criteria1. Unable to give written informed consent
2. Not prepared to provide blood and saliva samples as required
3. Taking the products/medications that stimulate immune function/inflammation. For example: β glucans, isoprinosine (methisoprinolum), ribomunyl, immunomodulators lysate of bacteria
4. Have taken probiotic supplements within 2 weeks of trial start
5. Pregnant or lactating
6. Received oral antibiotics within 3 weeks of trial start
Date of first enrolment05/12/2017
Date of final enrolment22/12/2017

Locations

Countries of recruitment

  • North Macedonia

Study participating centre

Saints Cyril and Methodius University of Skopje
The University Clinic of Pulmonology and Allergology
blvd. Goce Delcev 9
Skopje
1000
North Macedonia

Sponsor information

Cultech (United Kingdom)
Industry

Unit 2 Christchurch Road
Baglan Industrial Estate
Port Talbot
SA12 7BZ
United Kingdom

Phone +44 (0)1639 825100
Email suep@cultech.co.uk
Website http://www.cultech.co.uk/
ROR logo "ROR" https://ror.org/00555bk04

Funders

Funder type

Industry

Cultech Ltd

No information available

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planResults will be published in a peer-reviewed scientific journal.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 15/05/2020 No No

Additional files

ISRCTN90136957_PROTOCOL.pdf
uploaded 15/05/2020

Editorial Notes

15/05/2020: Uploaded protocol (not peer reviewed) as an additional file.
01/04/2020: Trial’s existence confirmed by the Ethics Committee for Clinical and Other Investigations related to Medicines and Medical Supplies within the Agency for Medicines and Medical Supplies of the Republic of Macedonia.