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Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota (Restart)

5. maj 2026 opdateret af: Haukeland University Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

36

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Norge
    • Haugesund
    • Møre og Romsdal
    • Norway
      • Bergen, Norway, Norge, 5096
        • Haukeland University Hospital in Helse Bergen
    • Sola
      • Stavanger, Sola, Norge, 4050
        • Sola distriktspsykiatriske senter
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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)
Andet: Psychotherapy treatment as usual (TAU)
Psychotherapy treatment as usual (TAU)
Eksperimentel: 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)
Biologisk: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation
Tidsramme: 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.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body mass index (BMI)
Tidsramme: 1 year
Body mass index to assess weight development
1 year
Eating disorder evaluation quesionnaire (EDE-Q) score
Tidsramme: 1 year
Global score of the EDE-Q score will be used to assess eating disorder symptom severity
1 year
Clinical impairment assessment questionnaire (CIA)
Tidsramme: 1 year
CIA will be used to assess the degree of influence on every life of the patient
1 year
ROME 4
Tidsramme: 1 year
The patients will be assessed for the presence of ROME 4 criteria for functional gastrointestinal disorders including irritable bowel syndrome
1 year
Irritable bowel syndrome symptome severity score (IBS-SSS)
Tidsramme: 1 year
IBS-SSS is used to assess the intensity of IBS symptoms
1 year
Gastrointestinal symptom rating scale for IBS (GSRS-IBS)
Tidsramme: 1 year
GSRS-IBS will be used to assess the gastrointestinal symptoms of IBS
1 year
Fecal microbiota composition
Tidsramme: 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
1 week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Haukeland University Hospital

Samarbejdspartnere

The Dam Foundation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. november 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 763219
  • SDAM_FORS509460 (Andet bevillings-/finansieringsnummer: Stiftelsen Dam)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Aggregated, deidentified data

IPD-delingstidsramme

November 1st 2028 and for five years thereafter

IPD-delingsadgangskriterier

Contact with principal investigator

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Anoreksi

Kliniske forsøg med Psychotherapy treatment as usual (TAU)

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