1. Personalised azithromycin+metronidazole (PAZAZ), in combination with standard induction therapy, to achieve a faecal microbiome community structure and metagenome changes associated with sustained remission in paediatric Crohn’s disease (CD): protocol of a pilot study
- Author
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Verburgt, Charlotte M, Dunn, Katherine A, Otley, Anthony, Heyman, Melvin B, Verstraete, Sofia, Sunseri, Withney, Sylvester, Francisco, de Meij, Tim, Comeau, Andre, Langille, Morgan, de Jonge, Wouter J, Benninga, Marc A, and Van Limbergen, Johan E
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Nutrition ,Prevention ,Digestive Diseases ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Oral and gastrointestinal ,Good Health and Well Being ,Humans ,Child ,Crohn Disease ,Azithromycin ,Metronidazole ,Pilot Projects ,Induction Chemotherapy ,Metagenome ,Bayes Theorem ,RNA ,Ribosomal ,16S ,Anti-Bacterial Agents ,Remission Induction ,Microbiota ,Recurrence ,Randomized Controlled Trials as Topic ,Multicenter Studies as Topic ,paediatric gastroenterology ,inflammatory bowel disease ,clinical trials ,microbiology ,Public Health and Health Services ,Other Medical and Health Sciences ,Biomedical and clinical sciences ,Health sciences ,Psychology - Abstract
IntroductionEarly relapse in Crohn's disease (CD) is associated with a more severe disease course. The microbiome plays a crucial role, yet strategies targeting the microbiome are underrepresented in current guidelines. We hypothesise that early manipulation of the microbiome will improve clinical response to standard-of-care (SOC) induction therapy in patients with a relapse-associated microbiome profile. We describe the protocol of a pilot study assessing feasibility of treatment allocation based on baseline faecal microbiome profiles.Methods and analysisThis is a 52-week, multicentre, randomised, controlled, open-label, add-on pilot study to test the feasibility of a larger multicontinent trial evaluating the efficacy of adjuvant antibiotic therapy in 20 paediatric patients with mild-to-moderate-CD (10Ethics and disseminationThis study was approved by METC-AMC and CCMO (Netherlands) and IWK Health Centre (Canada). The first version of this protocol was approved by North Carolina Children's Hospital (USA), Wolfson Medical Centre (Israel). The FDA (USA), Health Canada and Ministry of Health (Israel) have reviewed and approved the protocol. Results will be published in international peer-reviewed journals and summaries will be provided to the funders and participants.Trial registration numberNCT04186247.
- Published
- 2023