RESUMO
INTRODUCTION: Early 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 ANALYSIS: This 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 (10Assuntos
Doença de Crohn
, Microbiota
, Humanos
, Criança
, Doença de Crohn/tratamento farmacológico
, Azitromicina/uso terapêutico
, Metronidazol/uso terapêutico
, Projetos Piloto
, Quimioterapia de Indução/métodos
, Metagenoma
, Teorema de Bayes
, RNA Ribossômico 16S
, Antibacterianos/uso terapêutico
, Indução de Remissão
, Recidiva
, Ensaios Clínicos Controlados Aleatórios como Assunto
, Estudos Multicêntricos como Assunto