Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHaukeland University Hospital

About this trial

In this pilot study 36 patients with anorexia nervosa (AN) will be randomized to either treatment with psychotherapy as usual (TAU) or TAU plus fecal microbiota transplantation (FMT). The transplantation will be performed when refeeding has started. Patients randomized to TAU+FMT will choose either capsules or gastroscopy as source of FMT. One week after FMT gut microbiota will be collected and analyzed and compared with microbiota composition at baseline. The two groups are then followed during psychotherapy to assess whether it is feasible to give FMT during psychotherapy to study the effects on outcome. In addition, this pilot study is aiming at paving the way for performing larger studies to assess whether FMT improves outcome from psychotherapy when given in combination with psychotherapy in patients with AN.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Psychotherapy as usual combined with single dose normal gut microbiota
  • Psychotherapy treatment as usual (TAU)

Treatment groups

36 Participants
are divided into 2 treatment groups

Locations

4
Haugalandet distriktspsykiatriske senter5535, HaugesundHaugesund, Norway
Helse Møre og Romsdal6026, ÅlesundMøre og Romsdal, Norway
Haukeland University Hospital in Helse Bergen5096, BergenNorway, Norway
Sola distriktspsykiatriske senter4050, StavangerSola, Norway

Sponsors and collaborators

Haukeland University Hospital

Lead sponsor

The Dam Foundation

Collaborator