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.
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Parallel
Psychotherapy as usual combined with single dose normal gut microbiota
Biological/VaccinePsychotherapy treatment as usual (TAU) combined with single dose normal fecal microbiota (FMT) will be compared with TAU
Psychotherapy treatment as usual (TAU)
Other interventionPsychotherapy treatment as usual (TAU)
Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation
A single dose of fecal microbiota transplantation will be administered when the patients has established a nutritional status allowing survival of the transplant. Then the patients will be followed to the end of psychotherapy. Assessments will include description of gut microbiota composition and questionnaires describing the clinical course of the eating disorder.
Body mass index (BMI)
Body mass index to assess weight development
Eating disorder evaluation quesionnaire (EDE-Q) score
Global score of the EDE-Q score will be used to assess eating disorder symptom severity
Clinical impairment assessment questionnaire (CIA)
CIA will be used to assess the degree of influence on every life of the patient
ROME 4
The patients will be assessed for the presence of ROME 4 criteria for functional gastrointestinal disorders including irritable bowel syndrome
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Haukeland University Hospital
Lead sponsor
The Dam Foundation
Collaborator
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