Probiotics - Clinical trial details 

Recruitment status:

Not Recruiting

Primary Sponsor:

Swansea University (UK)

Recruitment countries:

United Kingdom

Health condition studied:

Antibiotic-associated diarrhoea; C. difficile diarrhoea
Infections and Infestations
Diarrhoea and gastroenteritis of presumed infectious origin

URL:

Link to the clinical trial website

About the trial

Interventions:

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.

Key inclusion and exclusion criteria:

• 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
• 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)

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

Primary outcomes:

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 outcomes:

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

Target sample size:

2974

Study type:

Interventional

Study design:

Multicentre randomised controlled trial (Treatment)

Contacts:

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

• Name: Kathie Wareham
• Address:  Clinical Research Unit Morriston Hospital
• Phone:  +44 (0)1792 703722
• Email:  kathie.wareham@swansea-tr.wales.nhs.uk
• Affiliation: 

Technical details

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

Sources of monetary support:

Health Technology Assessment Programme

Secondary sponsors:

Main ID:

ISRCTN70017204

Secondary ID:

HTA 06/39/02

Register:

ISRCTN

Date of registration:

31/07/2009

Date of first enrollment:

01/12/2008

Last refreshed:

17 October 2016