Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota (Restart)
Reestablishing Normal Gut-Brain Interaction in Anorexia Nervosa With Normal Gut Microbiota: Restart
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Stein Frostad, MD PhD
- Número de teléfono: +47 95003257
- Correo electrónico: stein.frostad@helse-bergen.no
Copia de seguridad de contactos de estudio
- Nombre: Olivia B Helland, Master of Science
- Correo electrónico: olivia.bysheim.helland@helse-bergen.no
Ubicaciones de estudio
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Haugesund
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Haugesund, Haugesund, Noruega, 5535
- Haugalandet distriktspsykiatriske senter
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Contacto:
- Kenneth Eikeset, MD
- Correo electrónico: kenneth.eikeset@helse-fonna.no
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Møre og Romsdal
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Ålesund, Møre og Romsdal, Noruega, 6026
- Helse Møre og Romsdal
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Contacto:
- Dag AL Hoff, MD PhD
- Correo electrónico: Dag.Arne.Lihaug.Hoff@helse-mr.no
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Norway
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Bergen, Norway, Noruega, 5096
- Haukeland University Hospital in Helse Bergen
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Sola
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Stavanger, Sola, Noruega, 4050
- Sola distriktspsykiatriske senter
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Contacto:
- Øystein Enger, Specialist Clinical Psychology
- Correo electrónico: oystein.enger@sus.no
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Psychotherapy treatment as usual (TAU)
The 18 patient with anorexia nervosa randomized to this arm will receive treatment with psychotherapy for anorexia nervosa as usual (TAU) |
Psychotherapy treatment as usual (TAU) |
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Experimental: Patients receiving TAU in combination with FMT
The 18 patient with anorexia nervosa randomized to this arm will receive treatment with psychotherapy for anorexia nervosa as usual (TAU) in combination with a single dose fecal microbiota transplantation (FMT) |
Psychotherapy treatment as usual (TAU) combined with single dose normal fecal microbiota (FMT) will be compared with TAU |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation
Periodo de tiempo: 1 year
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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. |
1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body mass index (BMI)
Periodo de tiempo: 1 year
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Body mass index to assess weight development |
1 year
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Eating disorder evaluation quesionnaire (EDE-Q) score
Periodo de tiempo: 1 year
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Global score of the EDE-Q score will be used to assess eating disorder symptom severity |
1 year
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Clinical impairment assessment questionnaire (CIA)
Periodo de tiempo: 1 year
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CIA will be used to assess the degree of influence on every life of the patient |
1 year
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ROME 4
Periodo de tiempo: 1 year
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The patients will be assessed for the presence of ROME 4 criteria for functional gastrointestinal disorders including irritable bowel syndrome |
1 year
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Irritable bowel syndrome symptome severity score (IBS-SSS)
Periodo de tiempo: 1 year
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IBS-SSS is used to assess the intensity of IBS symptoms |
1 year
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Gastrointestinal symptom rating scale for IBS (GSRS-IBS)
Periodo de tiempo: 1 year
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GSRS-IBS will be used to assess the gastrointestinal symptoms of IBS |
1 year
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Fecal microbiota composition
Periodo de tiempo: 1 week
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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 |
1 week
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Panah FM, Stoving RK, Sjogren M, Micali N, Maschek S, Reis KD, Mirsepasi-Lauridsen HC, Petersen AM, Nielsen DS, Helms M, Rasmussen MA, Barfod KK. Impact of a single fecal microbiome transplantation in adult women with anorexia nervosa: an open-label feasibility pilot trial. Nat Commun. 2026 Jan 14;17(1):1747. doi: 10.1038/s41467-026-68455-8.
- Frostad S. Are the Effects of Malnutrition on the Gut Microbiota-Brain Axis the Core Pathologies of Anorexia Nervosa? Microorganisms. 2022 Jul 24;10(8):1486. doi: 10.3390/microorganisms10081486.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 763219
- SDAM_FORS509460 (Otro número de subvención/financiamiento: Stiftelsen Dam)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Aggregated, deidentified data
Marco de tiempo para compartir IPD
November 1st 2028 and for five years thereafter
Criterios de acceso compartido de IPD
Contact with principal investigator
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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