GUMBIT

• Research type

  Research Study

• Full title

  A pilot study to investigate the gut microbiome in patients with immune thrombocytopenia (ITP)

• IRAS ID

  326323

• Contact name

  Nichola Cooper

• Contact email

  n.cooper@imperial.ac.uk

• Sponsor organisation

  Imperial College Healthcare NHS Trust/Imperial College London

• Duration of Study in the UK

  0 years, 11 months, 30 days

• Research summary

  Infections, including Helicobacter pylori (H. pylori), have been implicated in the pathogenesis of immune thrombocytopenia (ITP). H. pylori affects the gut microbiome.
  Dysregulation of immune function mediated by the disturbance of the gut microbiome and the host-microbe interactions has already been shown to play an important role in the pathophysiology of other autoimmune diseases. There is anecdotal evidence that the use of antibiotics, probiotics, and intermittent fasting leads to a significant increase in the platelet count in some ITP patients.

  We believe the gut microbiome may also play a role in the pathophysiology of ITP. By analysing the gut microbiome of the ITP population, we may identify clues for better treatments and biomarkers to stratify patients and optimise treatment.

  Hypothesis: the gut microbiome of patients with ITP is altered compared to that of healthy controls.

  If we identify changes in the gut microbiome of ITP patients, our data may be used to design a prospective trial to alter the gut microbiome in ITP patients (either through diet, the use of antibiotics or faecal microbiota transplants), more directed treatment for this condition than current therapies.

  The UK incidence of adult ITP is estimated to be around 120 per year and 3000–4000 people are affected at any one time. At the haematology clinic in the Hammersmith Hospital we visit 100 patients with ITP per month.

  We aim to recruit 60 participants, 20 patients with recurrent ITP, 20 with refractory ITP and 20 healthy controls, if possible, accompanying relatives to ITP patients to reflect similar behavioural and nutritional habits. Participants will be offered to participate in the haematology clinic and once informed consent is provided, a blood, urine and stool samples will be collected and 4 questionnaires completed. No follow up is required.

  The study is funded by the Imperial Health Charity.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  23/SW/0113

• Date of REC Opinion

  5 Oct 2023

• REC opinion

  Further Information Favourable Opinion