This innovative clinical research project will test a non-antibiotic triple therapy for the treatment of Travellers’ Diarrhoea (TD). This is a common occurrence when UK residents visit parts of the world such as India and South East Asia as well as South America. In China, TD is quite common and the first line treatment is antibiotic therapy (usually ciprofloxacin). This is an unnecessary use of valuable life saving antibiotics and so one major aim of our trial is to establish if our triple therapy could replace antibiotics ie be antibiotic sparing. Devised by Dr David Brown, previously a Trustee and chair of ANTRUK’s Science Committee, as a result of literature mining, the triple therapy consists of one over the counter pharmaceutical drug and two nutraceuticals obtained from health food shops, The triple therapy is given orally and in a few case studies has been proven to be effective in treating TD sometimes within 30 minutes. In order to speed up recruitment and keep costs low, the trial known as DIAMOND (DIarrhea Antibiotic Management using Over-the-counter Nutraceuticals in Daily practice) is being undertaken at Shanghai Jiading District Center Hospital, Shanghai, China.
The DIAMOND trial collaborators are Dr Jessika Hu (University of Hong Kong), Professor Paul Little, Dr Merlin Wilcox and Professor Michael Moore (University of Southampton), Dr David Brown (Alchemy Biomedical Consulting), Dr Xudong Zhou and colleagues at Zhejiang University and ANTRUK. As of January 2019, the following steps have been undertaken;
1) DIAMOND Trial registration on the WHO China Research Clinical Trials platform
2) Ethical approval from Chinese Research Clinical Trial Ethics Committee
3) Placebo Amino acid confirmed
4) Zhejiang University have agreed to be the Sponsor Institute in China
5) Ethics approval from Shanghai Hospital study site ethics committee
6) Insurance certificate obtained
7) Trial registered and approved at Southampton University
8) Ethics approval by Southampton University
9) DIAMOND Agreement and Clinical Protocol signed
10) Chinese doctors have been trained for recruitment
On 14 January 2019 the first trial patient was recruited. The total number of patients to be recruited for the trial is 120. As of 19 August 2019 some 70 patients have been recruited.
Funding has been partly raised for this pilot trial but more is needed. The initial funding has been provided by ANTRUK jointly with Dr David Brown.
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