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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Stein Frostad, MD PhD
- Telefoonnummer: +47 95003257
- E-mail: stein.frostad@helse-bergen.no
Studie Contact Back-up
- Naam: Olivia B Helland, Master of Science
- E-mail: olivia.bysheim.helland@helse-bergen.no
Studie Locaties
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Haugesund
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Haugesund, Haugesund, Noorwegen, 5535
- Haugalandet distriktspsykiatriske senter
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Contact:
- Kenneth Eikeset, MD
- E-mail: kenneth.eikeset@helse-fonna.no
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Møre og Romsdal
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Ålesund, Møre og Romsdal, Noorwegen, 6026
- Helse Møre og Romsdal
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Contact:
- Dag AL Hoff, MD PhD
- E-mail: Dag.Arne.Lihaug.Hoff@helse-mr.no
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Norway
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Bergen, Norway, Noorwegen, 5096
- Haukeland University Hospital in Helse Bergen
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Sola
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Stavanger, Sola, Noorwegen, 4050
- Sola distriktspsykiatriske senter
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Contact:
- Øystein Enger, Specialist Clinical Psychology
- E-mail: oystein.enger@sus.no
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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) |
|
Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Body mass index (BMI)
Tijdsspanne: 1 year
|
Body mass index to assess weight development |
1 year
|
|
Eating disorder evaluation quesionnaire (EDE-Q) score
Tijdsspanne: 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)
Tijdsspanne: 1 year
|
CIA will be used to assess the degree of influence on every life of the patient |
1 year
|
|
ROME 4
Tijdsspanne: 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)
Tijdsspanne: 1 year
|
IBS-SSS is used to assess the intensity of IBS symptoms |
1 year
|
|
Gastrointestinal symptom rating scale for IBS (GSRS-IBS)
Tijdsspanne: 1 year
|
GSRS-IBS will be used to assess the gastrointestinal symptoms of IBS |
1 year
|
|
Fecal microbiota composition
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 763219
- SDAM_FORS509460 (Ander subsidie-/financieringsnummer: Stiftelsen Dam)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Aggregated, deidentified data
IPD-tijdsbestek voor delen
November 1st 2028 and for five years thereafter
IPD-toegangscriteria voor delen
Contact with principal investigator
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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