Probiotics in the prevention of antibiotic-associated and C. difficile diarrhoea

Conditions

Antibiotic-associated diarrhoea

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.

2013-12-0139 citations

10.3310/hta17570

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.

Allen SJ, Wareham K, Wang D, Bradley C, Hutchings H, Harris W, Dhar A, Brown H, Foden A, Gravenor MB, Mack D.

2013-08-08236 citations

10.1016/s0140-6736(13)61218-0

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.

Allen SJ, Wareham K, Bradley C, Harris W, Dhar A, Brown H, Foden A, Cheung WY, Gravenor MB, Plummer S, Phillips CJ, Mack D.

2012-05-0613 citations

10.1186/1471-2334-12-108

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 bifi

Eligibility

Sex/Gender

All

Inclusion 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

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed