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Allen SJ, Wareham K, Wang D, et al. 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). Southampton (UK): NIHR Journals Library; 2013 Dec. (Health Technology Assessment, No. 17.57.)

Cover of 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)

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).

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Chapter 3Protocol changes

Inclusion and exclusion criteria

In practice, on assessment for eligibility, some patients were severely ill and not expected to survive for the intended period of follow-up; therefore, they were not approached regarding joining the study. Similarly, participants who were nil by mouth at initial assessment were not approached.

Follow-up

We had intended that diarrhoea outcomes would be assessed during antibiotic treatment and for 8 weeks after stopping antibiotics. However, prolonged follow-up for participants on long courses of antibiotics was not feasible. In practice, daily follow-up during hospital stay or weekly follow-up after discharge from hospital was continued to 8 weeks after recruitment. Review of laboratory data regarding stool assays was continued until 12 weeks after recruitment.

Assessment of quality of life

We considered modifying tools validated to measure QoL in treatment-induced diarrhoea in people with HIV54 and older patients with faecal incontinence.55 However, we considered that completion of additional questionnaires would be too onerous for elderly inpatients and these were not pursued.

Copyright © Queen’s Printer and Controller of HMSO 2013. This work was produced by Allen et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK261338
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