Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Kathie Wareham

ORCID ID

Contact details

Clinical Research Unit
Morriston Hospital
Swansea
SA6 6NL
United Kingdom
+44 (0)1792 703722
kathie.wareham@swansea-tr.wales.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 06/39/02

Study information

Scientific title

A multicentre, randomised, placebo controlled trial of lactic acid bacteria and bifidobacteria in the prevention of antibiotic-associated diarrhoea (AAD) and Clostridium difficile diarrhoea (CDD) in patients aged 65 years and over admitted to hospital and receiving antibiotics

Acronym

PLACIDE

Study hypothesis

A probiotic food supplement is effective in preventing antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital and receiving antibiotics.

Ethics approval

Research Ethics Committee for Wales, 27/11/2008

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Antibiotic-associated diarrhoea; C. difficile diarrhoea

Intervention

1. Live bacteria of human origin: 2 strains of Lactobacillus acidophilus (CUL60, National Collection of Industrial, Food and Marine Bacteria [NCIMB] 30157 and CUL21, NCIMB 30156), Bifidobacterium bifidum (CUL20, NCIMB 30153), Bifidobacterium lactis (CUL34, NCIMB 30172). Prepared as lyophilised powder in a capsule containing 6 x 1010 organisms/capsule.
2. Identical formulation of inert placebo: maltodextrin

The dose of probiotic is prepared in 5 g lyophilised powder in a capsule - the placebo is a matched capsule with 5 g of maltodextrin. Dosing is daily for 21 days via the oral route. The total duration of follow-up is 8 weeks from the end of antibiotics to a maximum of 12 weeks if other courses of antibiotics are given.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Probiotic supplementation

Primary outcome measures

During antibiotic treatment and within 8 weeks of stopping antibiotics:
1. The occurrence of antibiotic associated diarrhoea (AAD)
2. The occurrence of C. difficile diarrhoea (CDD)

Secondary outcome measures

1. Severity and duration of AAD
2. Abdominal symptoms (abdominal pain, bloating, flatus, nausea)
3. Severity and duration of CDD and incidence of recurrence within the study period
4. Incidence of pseudomembranous colitis (PMC), need for colectomy, death
5. Well-being and quality of life
6. Duration of hospital stay
7. Adverse effects
8. Acceptability of the probiotic preparation
9. Viability of the probiotic at point of administration
All of these outcomes will be measured during the period from participant recruitment to 8 weeks after stopping antibiotics, to a maximum of 12 weeks from recruitment.

10. Risk factors for ADD, CDD and severe disease (PMC, colectomy, death), assessed at participant recruitment

Overall trial start date

01/12/2008

Overall trial end date

01/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. People aged greater than or equal to 65 years, either sex
2. Admitted to hospital without diarrhoea
3. Have been exposed to one or more antibiotics within the last 7 days or are about to start antibiotic treatment

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

2,974

Participant exclusion criteria

1. People with known immunosuppressive disorder, prosthetic heart valve or active inflammatory bowel disease (the latter defined as requiring specific treatment in the past 12 months)
2. Acute pancreatitis (defined as abdominal pain with serum amylase or lipase concentration greater than or equal to three times the institutional upper limit of normal)
3. Jejunal tube in-situ and/or jejunal feeding (as documented in the clinical/nursing records)
4. Likely impaired splanchnic perfusion: any past or current abnormality or disease affecting the mesenteric arteries (as documented in the clinical records)
5. Severe illness requiring care in either a high dependency or intensive care unit (but not planned admission to these facilities for observation only, e.g., after cardiac surgery)
6. People with a previous history of adverse reactions to probiotics
7. Informed consent not granted by patient or their carer(s)

Recruitment start date

01/12/2008

Recruitment end date

01/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Research Unit
Swansea
SA6 6NL
United Kingdom

Sponsor information

Organisation

Swansea University (UK)

Sponsor details

Singleton Park
Swansea
West Glamorgan
SA2 8PP
United Kingdom
+44 (0)1792 205678
c.d.jones@swansea.ac.uk

Sponsor type

University/education

Website

http://www.swansea.ac.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22559011
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23932219
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24309198

Publication citations

  1. Protocol

    Allen SJ, Wareham K, Bradley C, Harris W, Dhar A, Brown H, Foden A, Cheung WY, Gravenor MB, Plummer S, Phillips CJ, Mack D, A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol., BMC Infect. Dis., 2012, 12, 108, doi: 10.1186/1471-2334-12-108.

  2. Results

    Allen SJ, Wareham K, Wang D, Bradley C, Hutchings H, Harris W, Dhar A, Brown H, Foden A, Gravenor MB, Mack D, Lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea and Clostridium difficile diarrhoea in older inpatients (PLACIDE): a randomised, double-blind, placebo-controlled, multicentre trial., Lancet, 2013, 382, 9900, 1249-1257, doi: 10.1016/S0140-6736(13)61218-0.

  3. Results

    Allen SJ, Wareham K, Wang D, Bradley C, Sewell B, Hutchings H, Harris W, Dhar A, Brown H, Foden A, Gravenor MB, Mack D, Phillips CJ, A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE)., Health Technol Assess, 2013, 17, 57, 1-140, doi: 10.3310/hta17570.

Editorial Notes