Background A recent systematic review and meta-analysis identified a paucity of randomised-controlled trials (RCTs) investigating the use of probiotics to reduce or prevent mucositis and infection in children with cancer.
Objective This study evaluated the feasibility of undertaking an RCT and investigated the efficacy of probiotics for reducing or preventing mucositis and infection in children with cancers.
Setting The Paediatric Oncology and Haematology department at Leeds Teaching Hospital, UK.
Patients Children aged 1 year or older, receiving chemotherapies likely to cause mucositis.
Interventions Participants were randomised to receive the probiotic or placebo on day 1–14 of a chemotherapy cycle. Participants were also required to complete a patient diary for 21 days.
Main outcome measures To assess whether it is feasible to recruit children diagnosed with cancer who are at risk of developing mucositis to an adequately powered RCT.
Results Between May and November 2019, 34 out of 39 eligible participants were approached. Ten patients were recruited (4 probiotic and 6 placebo) of which 2 participants withdrew. Seven participants partially completed the diary but only two participants completed 80% or more. Eligible participants appeared to prefer giving informal verbal feedback when in direct contact with research and healthcare professionals.
Conclusion This study demonstrated that recruitment needs to be improved prior to undertaking an adequately powered RCT.
Trial registration number NCT03785938.
- qualitative research
- data collection
Data availability statement
Data may be obtained from a third party and are not publicly available. The protocol for this study is accessible online.
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Twitter @hhassan90210, @drbobphillips
Contributors HH designed and undertook the research described in this and also wrote the first and repeated drafts of this manuscript. BP and SK both supervised HH while undertaking this study and also gave feedback for the initial and subsequent manuscript drafts.
Funding This work was supported by Candlelighters charity who funded Dr Hadeel Hassan’s PhD, for which this research was conducted. Symprove company donated the probiotic and placebos free of charge and gave a voluntary donation to the development of the web-app.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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