HERACLES

• Research type

  Research Study

• Full title

  Treatment of steroid refractory gastro-intestinal acute graft-versus-Host disEase afteR AllogeneiC hematopoietic stem celL transplantation with faEcal microbiota transfer (HERACLES)

• IRAS ID

  255546

• Contact name

  Amit Patel

• Contact email

  Amit.Patel@christie.nhs.uk

• Sponsor organisation

  MaaT Pharma

• Eudract number

  2017-002697-39

• Clinicaltrials.gov Identifier

  NCT03359980

• Duration of Study in the UK

  0 years, 12 months, 0 days

• Research summary

  Summary of Research
  This is a single arm, international, multicentre, prospective, phase IIa study to assess the safety and efficacy of faecal microbiota transfer (FMT) in patients with steroid refractory acute graft versus host disease (aGVHD) with gut predominance following allogeneic haematopoietic stem cell transfer (allo-HSCT).

  GVHD is one a major complications of allo-HSCT and occurs when engrafted cells recognise the host’s own organ cells as foreign and attack them. The main organs affected are the skin, liver, and/or the intestines. Standard first line treatment of aGVHD is corticosteroids, however, in patients who do not respond to corticosteroid therapy there is a very high rate of morbidity and mortality.

  It is now believed that a lack of gut microbiota diversity may contribute to the incidence and severity of GVHD in patients who have had an allo–HSCT and who are resistant to corticosteroid therapy. Such patients may benefit from a treatment, such as FMT.

  In recent years, FMT has been used a successful and safe treatment for a number of diverse conditions including recurrent clostridium difficile infection and inflammatory bowel disease. FMT consists in administering a healthy microbiota into the host’s intestine with the aim of improving and restoring the gut microbial diversity and homeostasis with the host. MaaT013 is characterised by a high diversity and richness of microbial species derived from pooled healthy donors and manufactured in cGMP conditions. In the current study, MaaT013 will be administered via the lower gastrointestinal route by rectal enema.

  Summary of results
  : https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRnjaLp0p0COXkgCSIH2pfqNloAV3QcmZ-2B3oCDEaLS6mWlxm3h1M3F1wm3Ul6ZTcd0YeQ7blChF0U0WtXin57sY-3DWATC_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIbIjVXBHMM8cidEOMV94PoHdMSIT8qGLpK1NVYybTTwrbG69sjXmUx2hVhbGCYQdb2Mj8sqD9HlPAEj16E67l0L-2BeShCW637PzG1zV8rnZzabRM08BzHBCMq4bDL-2FoVWi-2FFfWcrQjmj4P7m1p0Mb-2FIPk7s4lxEAwxjUu2S-2FBO32Q-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C0a66697e335a476087ef08db08668c75%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638113008753346646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Q%2BL%2F%2BLjdMaMjAOnEDUJrKgrl9i0u2e6k0KnS3JihM7w%3D&reserved=0

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  18/LO/2134

• Date of REC Opinion

  7 Feb 2019

• REC opinion

  Further Information Favourable Opinion