Anorexia NervosaPhase 1RestartNCT07574892
Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota
A Phase 1 study testing Psychotherapy as usual combined with single dose normal gut microbiota and Psychotherapy treatment as usual (TAU) in people with Anorexia Nervosa, run by Haukeland University Hospital at 4 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Psychotherapy as usual combined with single dose normal gut microbiota and Psychotherapy treatment as usual (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesNorway
- Study dates
- 1 Dec 2026to Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or more Starting outpatient psychotherapy for anorexia nervosa At least one failed qualified treatment attempt
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Olivia B Helland, Master of Science contact
Norway4 sites
Helse Møre og Romsdal
Ålesund, Møre og Romsdal, 6026
Dag AL Hoff, MD PhD, Dag.Arne.Lihaug.Hoff@helse-mr.no
Haukeland University Hospital in Helse Bergen
Bergen, Norway, 5096
Haugalandet distriktspsykiatriske senter
Haugesund, Haugesund, 5535
Kenneth Eikeset, MD, kenneth.eikeset@helse-fonna.no
Sola distriktspsykiatriske senter
Stavanger, Sola, 4050
Øystein Enger, Specialist Clinical Psychology, oystein.enger@sus.no
About this study
Official title: 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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Psychotherapy as usual combined with single dose normal gut microbiota, Psychotherapy treatment as usual (TAU)
- Keywords
- Anorexia nervosa, Fecal microbiota transplantation, Psychotherapy
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotherapy as usual combined with single dose normal gut microbiotaBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy treatment as usual (TAU) | Active comparator | The 18 patient with anorexia nervosa randomized to this arm will receive treatment with psychotherapy for anorexia nervosa as usual (TAU) Receives: Other: Psychotherapy treatment as usual (TAU) |
| Patients receiving TAU in combination with FMT | Experimental | 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) Receives: Biological: Psychotherapy as usual combined with single dose normal gut microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation
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.
Measured: 1 year
Secondary outcomes (7)
Body mass index (BMI)
Body mass index to assess weight development
Measured: 1 year
Eating disorder evaluation quesionnaire (EDE-Q) score
Global score of the EDE-Q score will be used to assess eating disorder symptom severity
Measured: 1 year
Clinical impairment assessment questionnaire (CIA)
CIA will be used to assess the degree of influence on every life of the patient
Measured: 1 year
ROME 4
The patients will be assessed for the presence of ROME 4 criteria for functional gastrointestinal disorders including irritable bowel syndrome
Measured: 1 year
Irritable bowel syndrome symptome severity score (IBS-SSS)
IBS-SSS is used to assess the intensity of IBS symptoms
Measured: 1 year
Gastrointestinal symptom rating scale for IBS (GSRS-IBS)
GSRS-IBS will be used to assess the gastrointestinal symptoms of IBS
Measured: 1 year
Fecal microbiota composition
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574892
- Sponsor's protocol ID
- 763219
- Other IDs
- SDAM_FORS509460
- Acronym
- Restart
- Status last verified
- Sep 2026
- First submitted
- 27 Apr 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated, deidentified data
Publications
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.
PubMed 41535289Frostad 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.
PubMed 35893544
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reestablishing Normal Gut-Brain Interaction in Anorexia Nervosa With Normal Gut Microbiota: Restart
- ClinicalTrials.gov ID
- NCT07574892
- Acronym / sponsor ID
- Restart / 763219
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Fecal microbiota transplantation, Psychotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- The Dam Foundation
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy treatment as usual (TAU) | Active comparator | Other: 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) |
| Patients receiving TAU in combination with FMT | Experimental | Biological: Psychotherapy as usual combined with single dose normal gut microbiotaThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years or more Starting outpatient psychotherapy for anorexia nervosa At least one failed qualified treatment attempt
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy as usual combined with single dose normal gut microbiotaPsychotherapy treatment as usual (TAU) combined with single dose normal fecal microbiota (FMT) will be compared with TAU | Biological | Patients receiving TAU in combination with FMT |
| Psychotherapy treatment as usual (TAU)Psychotherapy treatment as usual (TAU) | Other | Psychotherapy treatment as usual (TAU) |
Primary outcome
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.
7 secondary outcomes
Body mass index (BMI)
Time frame: 1 year
Eating disorder evaluation quesionnaire (EDE-Q) score
Time frame: 1 year
Clinical impairment assessment questionnaire (CIA)
Time frame: 1 year
ROME 4
Time frame: 1 year
Irritable bowel syndrome symptome severity score (IBS-SSS)
Time frame: 1 year
Gastrointestinal symptom rating scale for IBS (GSRS-IBS)
Time frame: 1 year
Fecal microbiota composition
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 41535289Panah 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.
- Background: PubMed 35893544Frostad 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.
- Individual participant dataSharing planned: Yes. Aggregated, deidentified data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivia B Helland, Master of Science contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psychotherapy as usual combined with single dose normal gut microbiota and Psychotherapy treatment as usual (TAU) in people with Anorexia Nervosa, run by Haukeland University Hospital at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stein Frostad, MD PhD (+47 95003257, stein.frostad@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07574892, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.