Antibiotic-associated and C. difficile diarrhoea
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1 Antibiotic-associated and C. difficile diarrhoea NIHR HTA Commissioning Brief Are probiotics effective and costeffective in preventing antibiotic associated diarrhoea in older people? International Scientific Association for Probiotics and Prebiotics Aberdeen; June 2014 Pépin J et al. 2004; An epidemic of CDAD with an increased case fatality rate has had important consequences on the elderly population of our region. 1
2 Rationale for probiotics Antibiotics result in diarrhoea via several possible mechanisms: knocking out the commensal gut flora resulting in loss of colonisation resistance against pathogenic organisms important physiological functions direct effects Hypothesis: Probiotics given alongside antibiotics would replenish the healthy gut flora and prevent diarrhoea HTA commissioning brief Technology: Probiotics Patient group: Adults aged 65 years and over receiving antibiotic therapy Setting: Secondary care inpatients Control or comparator treatment: Placebo Design: Primary research in the form of an RCT Justify choice of probiotic agent indicate how quality of preparation will be assessed Outcomes: Incidence and duration of antibiotic associated diarrhoea + rate of recurrence Incidence and duration of C.difficile toxin positive diarrhoea Incidence of other gastrointestinal symptoms (e.g. abdominal pain, bloating, flatus & nausea) Quality of life Length of hospital stay Need for colectomy Cost effectiveness Minimum duration of follow up : 2m after cessation of antibiotics 2
3 Settings and trial population 5 recruitment sites: Durham / Darlington (catchment population 0.5m) Darlington Memorial (476 beds) University Hospital North Durham (591 beds) Swansea (catchment population 0.55m) Morriston (693 beds) Singleton (524 beds) Bridgend (548 beds) Participants Inclusion criteria In-patients Age 65 years or more Treated with antibiotic(s) in last 7 days or about to start treatment Recruited 2981 in-patients 65 years exposed to antibiotics Exclusion criteria Diarrhoea present C. difficile in past 3 months Active inflammatory bowel disease Immunocompromise Prosthetic heart valve Severe illness Suspected pancreatitis Compromised gut blood supply Jejunal feeding Unwilling to discontinue probiotic use 3
4 Which probiotic? Probiotic(s) evaluated: S. boulardii S. boulardii S. boulardii S. boulardii L. acidophilus and L. bulgaricus Lactobacillus GG L. acidophilus and B. longum E. faecium SF68 L. acidophilus and L. bulgaricus Studies in children D'Souza AL et al. BMJ 2002; 324:1361 Intervention multi-strain / high dose 4 strains of live bacteria of human origin: 2 strains of Lactobacillus acidophilus (CUL60 and CUL21) Bifidobacterium bifidum (CUL20) Bifidobacterium lactis (CUL34) Total: 6 x organisms/day for 21 days Lyophilised powder in a capsule Placebo: identical formulation of inert maltodextrin Participants randomised 1:1 to probiotic or inert placebo 4
5 Co-primary outcomes Diarrhoea 3 or more stools that take the shape of the container in a 24 hour period Antibiotic-associated diarrhoea diarrhoea occurring in association with antibiotic treatment without an alternative cause 8 weeks follow-up C. difficile diarrhoea Antibiotic-associated diarrhoea with a positive C. difficile toxin test 12 weeks follow-up Trial Profile Assessed 17,420 Randomised excluded 9068 declined 2130 too unwell 39 nil by mouth 1493 microbial preparation 1488 placebo Withdrawn / lost to follow up 6 did not receive IMP 17 excluded 1 did not receive IMP 16 excluded Analysed
6 Vulnerable population Variable Microbial preparation Placebo Age: median (IQR) 77.2 ( ) 77.0 ( ) Hypertension 779 (53.5%) 812 (55.7%) COPD 350 (24.0%) 354 (24.2%) Diabetes 357 (24.4%) 314 (21.4%) Asthma 237 (16.2%) 232 (15.8%) Renal disease 127 (8.7%) 139 (9.5%) Dementia / Alzheimer s 61 (4.2%) 80 (5.5%) Hospital admission in past 8 weeks 488 (33.2%) 448 (30.5%) Most already taking several drugs Ant-acid therapies PPI H 2 blocker Drug Microbial preparation Placebo 582 (39.9%) 96 (6.6%) 567 (38.8%) 74 (5.1%) ACE inhibitor 425 (29.3%) 436 (30.0%) Antihypertensive 679 (46.8%) 716 (49.3%) Aspirin 597 (40.9%) 589 (40.4%) Oral hypoglycaemic 208 (14.2%) 188 (12.9%) NSAID 158 (10.9%) 135 (9.3%) Insulin 96 (6.6%) 78 (5.3%) 6
7 Antibiotic regimens often complex Drug / therapy Microbial preparation Placebo Penicillin 1052 (71.6%) 1061 (72.1%) Cephalosporin 359 (24.4%) 356 (24.2%) Combination therapy 1 class only 2 classes 3 or more classes Duration of therapy One dose 1-6 days 7-13 days 14 or more days 310 (21.1%) 407 (27.7%) 753 (51.2%) 133 (9.5%) 389 (27.7%) 402 (28.6%) 482 (34.3%) 310 (21.1%) 397 (27.0%) 764 (51.9%) 123 (8.8%) 398 (28.5%) 426 (30.5%) 451 (32.3%) What did we find? Microbial preparation N=1470 Placebo N=1471 RR (95% CI) P Value Antibiotic-associated diarrhoea 159 (10.8%) 153 (10.4%) 1.04 ( ) 0.71 C. difficile diarrhoea 12 (0.8%) 17 (1.2%) 0.71 ( )
8 Did something go wrong? Identity / viability of interventions checked (34 probiotic / 33 placebo) Flatus more common in probiotic (12.5%) vs. placebo (10.2%; P=0.045) Manual check every 10 th record Only ~58% diarrhoeal stools tested for C. difficile Had we missed the boat? Consistency of results No evidence of probiotic effect across secondary outcomes GI symptoms (x 8) Duration of hospital stay Morbidity Mortality Quality of life 8
9 Question 87 You are an F1 doctor looking after a patient admitted for hip replacement. You are asked by your consultant to find evidence on how to reduce the incidence of deep venous thrombosis (DVT) in such patients. He is worried following two recent cases of DVT in similar patients. You find a range of studies of different types. What type of study would provide you with the most useful evidence? A. Case control study B. Case series C. Cohort study D. Meta analysis of trials E. Randomised controlled trial Correct Answer: D Meta analysis of trials Meta-analysis: Antibiotic-associated diarrhoea* 63 RCTs / 11,811 participants pooled RR 0.58 (95% CI: ); P=0.001 I 2 =54% But Mostly small studies Variable quality *Hempel et al. JAMA 2012;307(18):
10 Wrong probiotic? Strain not identified in half of trials E. faecium SF68 L. GG L. GG L. acidophilus + L. casei L. GG L. acidophilus + L. casei S. boulardii Meta-analysis: C. difficile diarrhoea* 23 trials / 4,213 participants pooled RR % CI: P< ; I 2 =0% But. As for previous metaanalysis High C. diff frequency in controls in some trials *Goldenberg et al. Cochrane Database of Systematic Reviews
11 Back to the drawing board Colonisation resistance how does the microbiome differ between people? How do different antibiotics cause AAD? Can we match a specific probiotic effect to an underlying disease mechanism? Avoid term probiotic until health benefits proven Summary A multistrain, high dose preparation of live Lactobacilli and Bifidobacteria was NOT effective in preventing antibioticassociated or C. difficile diarrhoea Better understanding needed of how antibiotics result in diarrhoea strain-specific probiotic effects Caution in interpretation of meta-analysis of probiotic trials 11
12 Acknowledgments Swansea University / ABMU Health Board Kathie Wareham: Trial Manager Clare Fagan: Study Coordinator Wyn Harris: Elderly Care Dietrich Mack, Eugene Rees, Katherine Davies, Ian Thomas, Rhian Bourne: Microbiology Mike Gravenor: Statistics Berni Diethardt, Ceri Phillips: Health Economics Hayley Hutchings: Quality of Life Ian Russell, Mel Storey, Alan Watkins: WWORTH Susan Prosser: Library Obsidian Research - Sue Plummer County Durham and Darlington Foundation Trust Jill Deane: Project Supervisor Caroline Bradley: Antibiotic Pharmacist Anjan Dhar: Gastroenterology Helga Brown: Elderly Care Alwyn Foden: Respiratory Physician London School of Hygiene and Tropical Medicine - Duolao Wang: Statistics DMEC: John Williams, Kerenza Hood, Barney Hawthorne TSC: Stephen Bain, John Sloss Thank you for listening! 12
13 Estimate of AAD in controls in research settings Reference Participants No. (%) AAD Lactobacilli Thomas years 40/134 (29.9) Armuzzi 2001 mean 40 ±2 yrs; Rx H. pylori 8/30 (26.7) Cremonin years; Rx H. pylori 6/21 (28.6) Gotz 1979 adults 6/43 (14.0) Wunderlich 1989 adults 6/22 (27.3) Orrhage 1994 adults; Rx clindamycin 7/10 (70.0) Beniwal 2003 adults 23/97 (23.7) S. boulardii Surawicz 1989 Adults 14/64 (21.9) McFarland years; Rx β lactam 14/96 (14.6) Lewis 1998 >65 years 5/36 (13.9) Can years 7/80 (8.8) TOTAL 136/633 (21.5%) Meta-analysis: AAD/older people 13
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