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Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota
Sponsor: Haukeland University Hospital
Summary
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.
Official title: Reestablishing Normal Gut-Brain Interaction in Anorexia Nervosa With Normal Gut Microbiota: Restart
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-06-01
Completion Date
2028-12
Last Updated
2026-05-08
Healthy Volunteers
No
Conditions
Interventions
Psychotherapy as usual combined with single dose normal gut microbiota
Psychotherapy treatment as usual (TAU) combined with single dose normal fecal microbiota (FMT) will be compared with TAU
Psychotherapy treatment as usual (TAU)
Psychotherapy treatment as usual (TAU)
Locations (4)
Haugalandet distriktspsykiatriske senter
Haugesund, Haugesund, Norway
Helse Møre og Romsdal
Ålesund, Møre og Romsdal, Norway
Haukeland University Hospital in Helse Bergen
Bergen, Norway, Norway
Sola distriktspsykiatriske senter
Stavanger, Sola, Norway