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NCT Number: NCT07574892

Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Haugalandet distriktspsykiatriske senter, Haugesund, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychotherapy as usual combined with single dose normal gut microbiota

Biological

Psychotherapy treatment as usual (TAU) combined with single dose normal fecal microbiota (FMT) will be compared with TAU

Psychotherapy treatment as usual (TAU)

Other

Psychotherapy treatment as usual (TAU)

Primary outcomes

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

    Time frame: 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 outcomes

  1. Body mass index (BMI)

    Time frame: 1 year

    Body mass index to assess weight development

  2. Eating disorder evaluation quesionnaire (EDE-Q) score

    Time frame: 1 year

    Global score of the EDE-Q score will be used to assess eating disorder symptom severity

  3. Clinical impairment assessment questionnaire (CIA)

    Time frame: 1 year

    CIA will be used to assess the degree of influence on every life of the patient

  4. ROME 4

    Time frame: 1 year

    The patients will be assessed for the presence of ROME 4 criteria for functional gastrointestinal disorders including irritable bowel syndrome

  5. Irritable bowel syndrome symptome severity score (IBS-SSS)

    Time frame: 1 year

    IBS-SSS is used to assess the intensity of IBS symptoms

  6. Gastrointestinal symptom rating scale for IBS (GSRS-IBS)

    Time frame: 1 year

    GSRS-IBS will be used to assess the gastrointestinal symptoms of IBS

  7. Fecal microbiota composition

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Olivia B Helland, Master of Science

CONTACT

[email protected]

Stein Frostad, MD PhD

CONTACT

[email protected]

+47 95003257

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • The Dam Foundation

Registry information

Official study title

Reestablishing Normal Gut-Brain Interaction in Anorexia Nervosa With Normal Gut Microbiota: Restart

Acronym: Restart

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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