The MaCROS study
Research type
Research Study
Full title
Mucositis and infection reduction with liquid probiotics in children with cancer: a randomised-controlled feasibility study protocol
IRAS ID
246313
Contact name
Hadeel Hassan
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Probiotics are supplements which have ’friendly’ bacteria. It is thought that probiotics may help develop a healthy gut which can reduce some side effects of chemotherapy taken by people diagnosed with cancer. This includes diarrhoea, nausea, vomiting, mouth ulcers and severe abdominal pain (collectively known as mucositis), and infections. It is proposed the ’friendly’ bacteria minimise damage to the gut lining which may cause mucositis and prevent the ’bad’ bacteria from entering the bloodstream.\n\nThis study will be open to children diagnosed with cancers who are receiving chemotherapy that cause mucositis. Children entered in the study will be randomised to take probiotics or “dummy’ probiotics (known as a placebo) for 14 days from the start of their chemotherapy course. Participants or their parents/guardians will be asked to answer questions daily about mucositis for 3 weeks. Participants can fill in the diary using an online web-app or a paper diary. Data from clinical records of any children admitted to hospital during this period will also be collected. Children or their parents/guardians will be invited to discuss their experience of being involved in the study. This can be done over the phone or face to face.\n\nThe aim of this study is to investigate whether it is appropriate to undertake a larger study (called a randomised-controlled trial) by exploring recruitment, children and their parents experiences of taking the supplement, placebo, filling in the diary and the practicalities of undertaking the study. This is called a feasibility study.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0005
Date of REC Opinion
20 Mar 2019
REC opinion
Further Information Favourable Opinion