Anorexia Nervosa
Conditions
Keywords
Anorexia nervosa, Fecal microbiota transplantation, Psychotherapy
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALPsychotherapy 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
OTHERPsychotherapy treatment as usual (TAU)
Psychotherapy treatment as usual (TAU)
Sponsors
Haukeland University Hospital
The Dam Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized to two separat groups which will receive either psychotherapy treatment as usual (TAU) in combination with fecal microbiota transplantation or TAU alone
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 18 years or more Starting outpatient psychotherapy for anorexia nervosa At least one failed qualified treatment attempt
Exclusion criteria
Age below 18 years BMI below 16 kg/m2 Significant electrolyte disturbances Other signs of medical instability Presence of systemic disease, Immune deficiency Treated with immune-modulating medication Pregnancy Planning pregnancy Lactations Having undergone abdominal surgery (with the exception of appendectomy, cholecystectomy, caesarian section and hysterectomy) severe psychiatric disease (except anorexia nervosa) Use of probiotics or treatment with antibiotics within 8 weeks prior to study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (BMI) | 1 year | Body mass index to assess weight development |
| Eating disorder evaluation quesionnaire (EDE-Q) score | 1 year | Global score of the EDE-Q score will be used to assess eating disorder symptom severity |
| Clinical impairment assessment questionnaire (CIA) | 1 year | CIA will be used to assess the degree of influence on every life of the patient |
| ROME 4 | 1 year | The patients will be assessed for the presence of ROME 4 criteria for functional gastrointestinal disorders including irritable bowel syndrome |
| Irritable bowel syndrome symptome severity score (IBS-SSS) | 1 year | IBS-SSS is used to assess the intensity of IBS symptoms |
| Gastrointestinal symptom rating scale for IBS (GSRS-IBS) | 1 year | GSRS-IBS will be used to assess the gastrointestinal symptoms of IBS |
| Fecal microbiota composition | 1 week | 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 |
Countries
Norway
Contacts
CONTACTStein Frostad, MD PhD
CONTACTOlivia B Helland, Master of Science
Outcome results
None listed