Probiotics - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

Cardiff University

Recruitment countries:

United Kingdom

Health condition studied:

Specialty: Infectious diseases and microbiology
Infections and Infestations

URL:

Link to the clinical trial website

About the trial

Interventions:

Participants are randomised to one of two groups via an online system which uses the method of minimisation, with a random component set at 80%. There are two minimisation variables: the care home at which the participant is resident, and the participant’s gender.

Intervention arm: Once daily oral probiotic (Lactobacillus rhamnosus, LGG and Bifidobacterium animalis subsp. lactis, BB-12) for twelve months.
Placebo arm: Once daily oral placebo for twelve months.

Two follow-up visits will take place, at 3 and 12 months.

Key inclusion and exclusion criteria:

• Inclusion criteria: 1. Aged 65 years or older
  2. Currently living in a care home setting (residential, nursing or mixed)
  3. Participant is willing and able to give informed consent for participation in the trial OR if the participant lacks capacity, a consultee is willing to complete a consultee declaration form
• Exclusion criteria: 1. Is known to be immunocompromised (requiring immunosuppressants, long term high dose oral, intramuscular or intravenous steroids)
  2. Is currently taking regular probiotics and is not willing to adapt to trial protocol
  3. Is a temporary care home resident (i.e. less than 1 month of planned transitional/respite residential care)
  4. Death is thought to be imminent
  5. Lactose intolerant

• Age minimum: 
• Age maximum: 
• Gender:  Both

Primary outcomes:

1. Cumulative antibiotic administration days for all cause infections over twelve months
2. Total number of days of systemic antibiotic administration as recorded in care home medical records and discharge summaries if the participant is admitted to hospital, over twelve months

Secondary outcomes:

1. Cumulative Antibiotic Administration Days (CAAD) for five sub-categories of Common Infectious Diseases (Respiratory Tract Infection, Urinary Tract Infection, skin, Gastrointestinal Infections and unexplained fever); number, site, duration (mean and cumulative) of infection over twelve months as measured by data recorded at regular intervals by research nurses from care home records.
2. Antibiotic consumption as measured by data recorded at regular intervals by RN from care home records over 12 months
3. Hospitalisation rate as measured by data recorded at regular intervals by RN from care home records over 12 months
4. Mortality as measured by data recorded at regular intervals by RN from care home records over twelve months
5. Health Utility as measured using the EQ-5D at baseline, three months and twelve months
6. Wellbeing is measured using the ICECAP-O at baseline, three months and twelve months
7. Full blood count (FBC) as measured by laboratory analysis of blood samples taken at baseline and twelve months
8. Vitamin D levels as measured by laboratory analysis of blood samples taken at baseline and twelve months
9. Immunology - Patient’s cytokine and chemokine response in whole blood samples stimulated ex-vivo by Toll Like Receptors TLR2 and TLR4 as measured by laboratory analysis of samples taken at baseline and twelve months
10. Blood - Modified expression of Toll Like Receptors (TLR) as measured in circulating white blood cells from whole blood samples taken at baseline and twelve months
11. Antimicrobial resistance (AMR) as measured by Culture and antibiotic sensitivity of Gram-negative Enterobacteriaceae and Vancomycin resistant enterococci (VRE) from stool sample at baseline and twelve months
12. Presence of probiotic bacteria Lactobacillus rhamnosus, LGG and Bifidobacterium animalis subsp. lactis, BB-12, plus presence of (antimicrobial resistant) AMR bacteria and C. difficile in stool is measured by laboratory analysis of stool samples taken at baseline, three months and twelve months
13. Presence of oral Candida species in saliva is measured by semi-quantitiative laboratory analysis of saliva samples taken at baseline, three months and twelve months
14. Influenza vaccine response - Haemagglutination inhibition assay and antibody titers at two points during participation: one immediately prior to the vaccine being administered and one 28 days post vaccine administration

Target sample size:

330

Study type:

Interventional

Study design:

Randomised; Interventional; Design type: Not Specified, Not Specified (Treatment)

Contacts:

• Name:  
• Address: 
• Phone: 
• Email: 
• Affiliation: 

• Name: Christopher Butler
• Address:  Nuffield Department of Primary Care Health Sciences University of Oxford
• Phone: 
• Email: 
• Affiliation: 

Technical details

Scientific title:

A double-blind placebo controlled trial to evaluate the efficacy of probiotics (Lactobacillus rhamnosus, LGG and Bifidobacterium animalis subsp. lactis, BB-12) in reducing antibiotic administration for infection in care home residents

Sources of monetary support:

National Institute for Health Research

Secondary sponsors:

Main ID:

ISRCTN16392920

Secondary ID:

20338

Register:

ISRCTN

Date of registration:

20/07/2016

Date of first enrollment:

01/12/2016

Last refreshed:

17 October 2016