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.
Around fifty percent of the patients who enter psychotherapy for anorexia nervosa (AN) drop out from the psychotherapy. Nearly all patients who are unable to complete treatment have significant deterioration shortly after premature ending of psychotherapy. During the development of AN, the microbes in the gut are significantly altered probably due to malnutrition. Some studies indicate that these alterations in the composition of gut microbiota play a role in the maintenance of AN. In this study we are aiming at assessing the feasibility of combining psychotherapy with improvement of nutritional status with fecal microbiota transplantation (FMT). By improving the nutritional status of the patient before transplantation the transplant may have better survival with improved outcome. In this pilot study 36 patients who have at least one failed treatment attempt will be included. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Psychotherapy treatment as usual (TAU) combined with single dose normal fecal microbiota (FMT) will be compared with TAU
Psychotherapy treatment as usual (TAU)
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
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.
Time frame: 1 year
Body mass index (BMI)
Body mass index to assess weight development
Time frame: 1 year
Eating disorder evaluation quesionnaire (EDE-Q) score
Global score of the EDE-Q score will be used to assess eating disorder symptom severity
Time frame: 1 year
Clinical impairment assessment questionnaire (CIA)
CIA will be used to assess the degree of influence on every life of the patient
Time frame: 1 year
ROME 4
The patients will be assessed for the presence of ROME 4 criteria for functional gastrointestinal disorders including irritable bowel syndrome
Time frame: 1 year
Irritable bowel syndrome symptome severity score (IBS-SSS)
IBS-SSS is used to assess the intensity of IBS symptoms
Time frame: 1 year
Gastrointestinal symptom rating scale for IBS (GSRS-IBS)
GSRS-IBS will be used to assess the gastrointestinal symptoms of IBS
Time frame: 1 year
Fecal microbiota composition
The composition of gut microbiota will be assessed when the patient has started psychotherapy and has estaliblished regular eating. In addition, composition of gut microbiota will be assessed one week after fecal microbiota transplantation
Time frame: 1 week
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