Anorexia NervosaAN-SHIFTNCT07877675
Fecal Microbiota Transplantation in Females With Anorexia Nervosa
A study testing Fecal Microbiota Transplantation Capsule in people with Anorexia Nervosa, run by Andreas Munk Petersen at 2 sites in Denmark.
Trial summary
The goal of this clinical trial is to learn whether fecal microbiota transplantation (FMT) can change the gut microbiome and improve health outcomes in females with anorexia nervosa. FMT involves transferring microorganisms from the stool of a carefully screened healthy donor to the intestine of another person. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Fecal Microbiota Transplantation Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- 16 Nov 2026to 31 Dec 2029
- Phase
- Interventional
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female sex.
- Age ≥15 years.
- Diagnosis of AN according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) which includes BMI<18.5 or equivalent in adolescents.
- Ability to read and speak Danish.
- Ability to swallow study capsules.
- Provision of voluntary written informed consent prior to any study-specific procedures (and, for participants aged 15-17 years, written parental/legal guardian consent and participant assent in accordance with Danish regulations).
- Must have access to a standalone household freezer (Not in the freezer compartment of a refrigerator).
Who cannot join
- Age <15 years.
- Male sex.
- Current use of laxatives.
- Any somatic comorbidity that requires current medical treatment.
- Systemic antibiotic treatment within the past 3 months.
- Known inflammatory bowel disease, colorectal cancer, or other clinically significant chronic gastrointestinal disorder.
Show all 9Show fewer
- Pregnancy or breastfeeding.
- Current alcohol or substance use disorder.
- Known food allergy to E133 and E150c.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kenneth Klingenberg Barfod, Associate Professor, MSc, PhD contact
Dorte Bonde Zilstorff, MD contact
Denmark2 sites
Center for Eating and feeding Disorders Research (CEDaR), Specialist center for Eating Disorders for the Capital Region
Ballerup Municipality, Capital Region of Copenhagen, 2750
Stefana Darvariu, MSc, 004538645000, stefana.darvariu@regionh.dk
Nadia Micali, Professor, MD, MRCPsych, PhD
Copenhagen University Hospital - Amager and Hvidovre
Hvidovre, Capital Region of Copenhagen, 2650
Andreas Munk Petersen, Professor, MD, PhD, DMSc, 0045 38 62 59 60, andreas.munk.petersen@regionh.dk
Dorte Bonde Zilstorff, MD, dorte.bonde.zilstorff@regionh.dk
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Crossover Study of Fecal Microbiota Transplantation in Females With Anorexia Nervosa
The goal of this clinical trial is to learn whether fecal microbiota transplantation (FMT) can change the gut microbiome and improve health outcomes in females with anorexia nervosa. FMT involves transferring microorganisms from the stool of a carefully screened healthy donor to the intestine of another person. In this study, FMT will be given as capsules that are swallowed by the participants.
The main questions the study aims to answer are:
Read more
- Does repeated treatment with FMT change the gut microbiome in females with anorexia nervosa?
- Does FMT improve symptoms and other health outcomes related to anorexia nervosa?
- How does FMT affect gastrointestinal function, including bowel habits and gut transit time in females with anorexia nervosa?
- What medical problems or side effects do the participants experience during the study?
Researchers will compare FMT capsules with placebo capsules to see whether FMT affects the gut microbiome, gastrointestinal function, and symptoms related to anorexia nervosa. Placebo capsules are similar to the FMT capsules but do not contain donor fecal material.
Participants will:
- Receive five weekly FMT treatments and five weekly placebo treatments
- Be randomly assigned to receive either FMT followed by placebo or placebo followed by FMT
- Attend four study visits for clinical assessments and follow-up
- Provide stool and blood samples at the study visits
- Complete questionnaires about eating disorder symptoms, gastrointestinal symptoms, and general health
- Provide information about bowel habits and other aspects of gastrointestinal function
Neither the participants nor the study staff will know which treatment is being given during each treatment period. The study will include females aged 15 years or older with anorexia nervosa.
The study will help researchers better understand the relationship between the gut microbiome and anorexia nervosa and whether changing the gut microbiome with FMT could potentially be a future treatment approach.
Read the detailed description
Anorexia nervosa (AN) is a severe psychiatric disorder with high morbidity and limited effective treatment options. Emerging evidence suggests persistent gut microbiota (GM) dysbiosis in AN, potentially contributing to gastrointestinal symptoms, appetite dysregulation, and maintenance of the disorder via the gut-brain axis. While preliminary animal studies and human feasibility trials indicate that fecal microbiota transplantation (FMT) can induce biologically relevant GM shifts, no randomized controlled trials have evaluated repeated FMT in patients with AN.
Aim: To determine whether repeated oral FMT induces sustained changes in GM composition and improves clinical outcomes in adolescents and adults with AN.
Subjects and Methods: AN-SHIFT is a randomized, double-blind, placebo-controlled crossover study enrolling 60-80 female participants aged ≥15 years with AN defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Participants receive five weekly oral FMT treatments and five weekly placebo treatments in alternating sequence. Fecal and blood samples, gut-transit-time, toilet frequency and psychometric assessments are collected at baseline, during intervention, and at 3-month follow-up. The primary outcome is within-subject change in GM composition and donor-strain engraftment assessed by shotgun metagenomic sequencing. Secondary outcomes include, gut-transit-time alterations, eating disorder symptoms, gastrointestinal symptoms, appetite- and mood-related biomarkers, and their associations with GM changes. All participants will during the trial receive FMT either before or after placebo, and standard clinical care continues throughout the study period.
Perspectives: This study evaluates a biologically informed, low-risk intervention targeting a potential mechanism to alleviate comorbidities associated with AN in patients with AN. The findings will provide critical evidence on feasibility, safety, and biological efficacy and will inform future microbiome-based treatment strategies.
- Conditions
- Anorexia Nervosa
- Being tested
- Fecal Microbiota Transplantation Capsule, Placebo Capsule(s)
- Keywords
- Anorexia nervosa, Fecal microbiota transplantation, FMT, Gut microbiome, Gut microbiota, Microbiome, Eating disorders, Gastrointestinal function, Oral FMT, Placebo-controlled trial
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation CapsuleBiological
Fecal microbiota transplantation (FMT) will be administered orally as capsules containing fecal material from carefully screened healthy donors. Participants will receive five weekly FMT treatments during the FMT treatment period. The FMT capsules will be prepared according to the study protocol and administered under the supervision of the study team.
Placebo Capsule(s)Other
Placebo capsules (low calorie) are made from saline containing 5% (v/v) glycerol, cornstarch and food coloring (food coloring E150).
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | FMT week 1-5 → placebo week 6-10 Receives: Biological: Fecal Microbiota Transplantation Capsule; Other: Placebo Capsule(s) |
| B | Experimental | Placebo week 1-5 → FMT week 6-10 Receives: Biological: Fecal Microbiota Transplantation Capsule; Other: Placebo Capsule(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gut Microbiome Composition (T0-T1)
The primary endpoint is defined as the change in GM composition from baseline (T0) to week 5 (T1), comparing participants randomized to receive FMT during the first treatment period with those randomized to receive placebo during the first treatment period.
Microbiome compositions will be assessed using shotgun metagenomic sequencing of stool samples collected at T0 and T1. Global microbiome restructuring will be quantified using pre-specified compositional distance metrics based on centered log-ratio (CLR) transformed abundance data (e.g., Aitchison distance).
In addition, the recipient microbiome distance to the assigned donor microbiome will be calculated to quantify movement toward donor composition following treatment. The primary analysis will estimate the difference between-group in microbiome compositional change and donor-recipient distance reduction during the first 5-week treatment period.
Measured: Baseline (T0) - After first 5 weeks (T1)
Secondary outcomes (3)
Gut-/appetite-related clinical effects (T0-T1)
Change from baseline to week 5 in gastrointestinal and appetite-related symptoms, including: Self-reported BMI, gastrointestinal symptom burden, transit time, stool consistency and frequency, appetite and satiety-related biomarkers in serum, and food intake changes.
Measured: Baseline (T0) - After first 5 weeks (T1)
Eating-disorder symptom severity (T0-T1)
Change in eating-disorder symptom severity from baseline compared to placebo using validated eating-disorder questionnaires
Measured: Baseline (T0) - After first 5 weeks (T1)
Change in eating-disorder symptom severity from baseline (T0) to the 3-month follow-up (T3)
A secondary longer-term endpoint evaluates change in eating-disorder symptom severity from baseline (T0) to the 3-month follow-up (T3) using validated eating-disorder questionnaires.
Because all participants receive FMT during the crossover study design, this outcome is not placebo-controlled and is therefore considered secondary and exploratory. It will determine whether microbiome restructuring, and gut-related clinical changes are associated with changes in eating-disorder symptoms from the participant's own baseline.
Measured: From baseline (T0) to to the 3-month follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start16 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (61)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andreas Munk Petersen
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric Center Ballerup, University of Copenhagen
- Responsible party
- Sponsor-investigator, Andreas Munk Petersen, Hvidovre University Hospital
- Investigators
- Andreas Munk Petersen, Professor, MD, PhD, DMSc, Principal investigator, Gastrounit, Medical Section and Department of Clinical Microbiology, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark, and Department of Clinical Medicine, University of Copenhagen, DenmarkKenneth Klingenberg Barfod, Associate Professor, MSc, PhD, Study director, Food Microbiology, Gut Health and Fermentation, Department of Food Science (FOOD), University of Copenhagen, DenmarkNadia Micali, Professor, MD, MRCPsych, PhD, Study chair, Center for Eating and feeding Disorders Research (CEDaR), Specialist center for Eating Disorders for the Capital Region , Copenhagen University Hospital Herlev and Gentofte Hospital, DenmarkMorten Helms, MD, PhD, Study director, Department of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, DenmarkSofie Ingdam Halkjær, MSc, PhD, Study chair, Gastrounit, Medical Section, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, DenmarkHengameh Chloé Lauridsen, MSc-Eng, PhD, Study director, Department of Infectious Diseases, Copenhagen University Hospital Amger and Hvidovre, Hvidovre, DenmarkDennis Sandris Nielsen, Professor, MSc, PhD, Study chair, Food Microbiology, Gut Health and Fermentation, Department of Food Science (FOOD), University of Copenhagen, DenmarkRené Klinkby Støving, Professor, MD, PhD, Study chair, Department of Endocrinology, Center for Eating Disorders, Odense University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877675
- Sponsor's protocol ID
- H-26045729
- Other IDs
- 5336-00067B
- Acronym
- AN-SHIFT
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because of data protection and privacy considerations. The study data will be handled and analyzed by the authorized researchers involved in the study in accordance with applicable data protection regulations.
Publications
Satokari R, Mattila E, Kainulainen V, Arkkila PE. Simple faecal preparation and efficacy of frozen inoculum in faecal microbiota transplantation for recurrent Clostridium difficile infection--an observational cohort study. Aliment Pharmacol Ther. 2015 Jan;41(1):46-53. doi: 10.1111/apt.13009. Epub 2014 Oct 29.
PubMed 25355279Hsu M, Tun KM, Batra K, Haque L, Vongsavath T, Hong AS. Safety and Efficacy of Fecal Microbiota Transplantation in Treatment of Inflammatory Bowel Disease in the Pediatric Population: A Systematic Review and Meta-Analysis. Microorganisms. 2023 May 12;11(5):1272. doi: 10.3390/microorganisms11051272.
PubMed 37317246Rapoport EA, Baig M, Puli SR. Adverse events in fecal microbiota transplantation: a systematic review and meta-analysis. Ann Gastroenterol. 2022 Mar-Apr;35(2):150-163. doi: 10.20524/aog.2022.0695. Epub 2022 Feb 14.
PubMed 35479587Karimi M, Shirsalimi N, Hashempour Z, Salehi Omran H, Sedighi E, Beigi F, Mortezazadeh M. Safety and efficacy of fecal microbiota transplantation (FMT) as a modern adjuvant therapy in various diseases and disorders: a comprehensive literature review. Front Immunol. 2024 Sep 26;15:1439176. doi: 10.3389/fimmu.2024.1439176. eCollection 2024.
PubMed 39391303Diener C, Holscher HD, Filek K, Corbin KD, Moissl-Eichinger C, Gibbons SM. Metagenomic estimation of dietary intake from human stool. Nat Metab. 2025 Mar;7(3):617-630. doi: 10.1038/s42255-025-01220-1. Epub 2025 Feb 18.
PubMed 39966520Amchova P, Siska F, Ruda-Kucerova J. Food Safety and Health Concerns of Synthetic Food Colors: An Update. Toxics. 2024 Jun 27;12(7):466. doi: 10.3390/toxics12070466.
PubMed 39058118Asnicar F, Leeming ER, Dimidi E, Mazidi M, Franks PW, Al Khatib H, Valdes AM, Davies R, Bakker E, Francis L, Chan A, Gibson R, Hadjigeorgiou G, Wolf J, Spector TD, Segata N, Berry SE. Blue poo: impact of gut transit time on the gut microbiome using a novel marker. Gut. 2021 Sep;70(9):1665-1674. doi: 10.1136/gutjnl-2020-323877. Epub 2021 Mar 15.
PubMed 33722860Chehri M, Christensen AH, Halkjaer SI, Gunther S, Petersen AM, Helms M. Case series of successful treatment with fecal microbiota transplant (FMT) oral capsules mixed from multiple donors even in patients previously treated with FMT enemas for recurrent Clostridium difficile infection. Medicine (Baltimore). 2018 Aug;97(31):e11706. doi: 10.1097/MD.0000000000011706.
PubMed 30075573Cold F, Browne PD, Gunther S, Halkjaer SI, Petersen AM, Al-Gibouri Z, Hansen LH, Christensen AH. Multidonor FMT capsules improve symptoms and decrease fecal calprotectin in ulcerative colitis patients while treated - an open-label pilot study. Scand J Gastroenterol. 2019 Mar;54(3):289-296. doi: 10.1080/00365521.2019.1585939. Epub 2019 Apr 4.
PubMed 30946615Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.
PubMed 29980607Cold F, Svensson CK, Christensen AH, Gunther S, Petersen AM, Hansen LH, Helms M. Successful treatment of Clostridioidesdifficile infection with single-donorfaecal microbiota transplantation capsules. Dan Med J. 2022 Jan 20;69(2):A09210712.
PubMed 35088703Knowles KA, Olatunji BO. Specificity of trait anxiety in anxiety and depression: Meta-analysis of the State-Trait Anxiety Inventory. Clin Psychol Rev. 2020 Dec;82:101928. doi: 10.1016/j.cpr.2020.101928. Epub 2020 Oct 10.
PubMed 33091745Bech P, Rasmussen NA, Olsen LR, Noerholm V, Abildgaard W. The sensitivity and specificity of the Major Depression Inventory, using the Present State Examination as the index of diagnostic validity. J Affect Disord. 2001 Oct;66(2-3):159-64. doi: 10.1016/s0165-0327(00)00309-8.
PubMed 11578668Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
PubMed 7866415Adair CE, Marcoux GC, Cram BS, Ewashen CJ, Chafe J, Cassin SE, Pinzon J, Gusella JL, Geller J, Scattolon Y, Fergusson P, Styles L, Brown KE. Development and multi-site validation of a new condition-specific quality of life measure for eating disorders. Health Qual Life Outcomes. 2007 Apr 30;5:23. doi: 10.1186/1477-7525-5-23.
PubMed 17470290
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Crossover Study of Fecal Microbiota Transplantation in Females With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT07877675
- Acronym / sponsor ID
- AN-SHIFT / H-26045729
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Fecal microbiota transplantation, FMT, Gut microbiome, Gut microbiota, Microbiome, Eating disorders, Gastrointestinal function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Andreas Munk PetersenUniversity, hospital or other
- Collaborators
- Psychiatric Center Ballerup, University of Copenhagen
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Oct 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.
The goal of this clinical trial is to learn whether fecal microbiota transplantation (FMT) can change the gut microbiome and improve health outcomes in females with anorexia nervosa. FMT involves transferring microorganisms from the stool of a carefully screened healthy donor to the intestine of another person. In this study, FMT will be given as capsules that are swallowed by the participants.
The main questions the study aims to answer are:
- Does repeated treatment with FMT change the gut microbiome in females with anorexia nervosa?
- Does FMT improve symptoms and other health outcomes related to anorexia nervosa?
- How does FMT affect gastrointestinal function, including bowel habits and gut transit time in females with anorexia nervosa?
- What medical problems or side effects do the participants experience during the study?
Researchers will compare FMT capsules with placebo capsules to see whether FMT affects the gut microbiome, gastrointestinal function, and symptoms related to anorexia nervosa. Placebo capsules are similar to the FMT capsules but do not contain donor fecal material.
Participants will:
- Receive five weekly FMT treatments and five weekly placebo treatments
- Be randomly assigned to receive either FMT followed by placebo or placebo followed by FMT
- Attend four study visits for clinical assessments and follow-up
- Provide stool and blood samples at the study visits
- Complete questionnaires about eating disorder symptoms, gastrointestinal symptoms, and general health
- Provide information about bowel habits and other aspects of gastrointestinal function
Neither the participants nor the study staff will know which treatment is being given during each treatment period. The study will include females aged 15 years or older with anorexia nervosa.
The study will help researchers better understand the relationship between the gut microbiome and anorexia nervosa and whether changing the gut microbiome with FMT could potentially be a future treatment approach.
Detailed description
Anorexia nervosa (AN) is a severe psychiatric disorder with high morbidity and limited effective treatment options. Emerging evidence suggests persistent gut microbiota (GM) dysbiosis in AN, potentially contributing to gastrointestinal symptoms, appetite dysregulation, and maintenance of the disorder via the gut-brain axis. While preliminary animal studies and human feasibility trials indicate that fecal microbiota transplantation (FMT) can induce biologically relevant GM shifts, no randomized controlled trials have evaluated repeated FMT in patients with AN.
Aim: To determine whether repeated oral FMT induces sustained changes in GM composition and improves clinical outcomes in adolescents and adults with AN.
Subjects and Methods: AN-SHIFT is a randomized, double-blind, placebo-controlled crossover study enrolling 60-80 female participants aged ≥15 years with AN defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Participants receive five weekly oral FMT treatments and five weekly placebo treatments in alternating sequence. Fecal and blood samples, gut-transit-time, toilet frequency and psychometric assessments are collected at baseline, during intervention, and at 3-month follow-up. The primary outcome is within-subject change in GM composition and donor-strain engraftment assessed by shotgun metagenomic sequencing. Secondary outcomes include, gut-transit-time alterations, eating disorder symptoms, gastrointestinal symptoms, appetite- and mood-related biomarkers, and their associations with GM changes. All participants will during the trial receive FMT either before or after placebo, and standard clinical care continues throughout the study period.
Perspectives: This study evaluates a biologically informed, low-risk intervention targeting a potential mechanism to alleviate comorbidities associated with AN in patients with AN. The findings will provide critical evidence on feasibility, safety, and biological efficacy and will inform future microbiome-based treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: Fecal Microbiota Transplantation Capsule, Other: Placebo Capsule(s)FMT week 1-5 → placebo week 6-10 |
| B | Experimental | Biological: Fecal Microbiota Transplantation Capsule, Other: Placebo Capsule(s)Placebo week 1-5 → FMT week 6-10 |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Female sex.
- Age ≥15 years.
- Diagnosis of AN according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) which includes BMI<18.5 or equivalent in adolescents.
- Ability to read and speak Danish.
- Ability to swallow study capsules.
Key exclusion criteria (9 listed)
- Age <15 years.
- Male sex.
- Current use of laxatives.
- Any somatic comorbidity that requires current medical treatment.
- Systemic antibiotic treatment within the past 3 months.
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 |
|---|---|---|
| Fecal Microbiota Transplantation CapsuleFecal microbiota transplantation (FMT) will be administered orally as capsules containing fecal material from carefully screened healthy donors. Participants will receive five weekly FMT treatments during the FMT treatment period. The FMT capsules will be prepared according to the study protocol and administered under the supervision of the study team. | Biological | A, B |
| Placebo Capsule(s)Placebo capsules (low calorie) are made from saline containing 5% (v/v) glycerol, cornstarch and food coloring (food coloring E150). | Other | A, B |
Primary outcome
Change in Gut Microbiome Composition (T0-T1)
Time frame: Baseline (T0) - After first 5 weeks (T1)
The primary endpoint is defined as the change in GM composition from baseline (T0) to week 5 (T1), comparing participants randomized to receive FMT during the first treatment period with those randomized to receive placebo during the first treatment period. Microbiome compositions will be assessed using shotgun metagenomic sequencing of stool samples collected at T0 and T1. Global microbiome restructuring will be quantified using pre-specified compositional distance metrics based on centered log-ratio (CLR) transformed abundance data (e.g., Aitchison distance). In addition, the recipient microbiome distance to the assigned donor microbiome will be calculated to quantify movement toward donor composition following treatment. The primary analysis will estimate the difference between-group in microbiome compositional change and donor-recipient distance reduction during the first 5-week treatment period.
3 secondary outcomes
Gut-/appetite-related clinical effects (T0-T1)
Time frame: Baseline (T0) - After first 5 weeks (T1)
Eating-disorder symptom severity (T0-T1)
Time frame: Baseline (T0) - After first 5 weeks (T1)
Change in eating-disorder symptom severity from baseline (T0) to the 3-month follow-up (T3)
Time frame: From baseline (T0) to to the 3-month follow-up (T3)
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 16 Oct 2026.
- Background: PubMed 25355279Satokari R, Mattila E, Kainulainen V, Arkkila PE. Simple faecal preparation and efficacy of frozen inoculum in faecal microbiota transplantation for recurrent Clostridium difficile infection--an observational cohort study. Aliment Pharmacol Ther. 2015 Jan;41(1):46-53. doi: 10.1111/apt.13009. Epub 2014 Oct 29.
- Background: PubMed 37317246Hsu M, Tun KM, Batra K, Haque L, Vongsavath T, Hong AS. Safety and Efficacy of Fecal Microbiota Transplantation in Treatment of Inflammatory Bowel Disease in the Pediatric Population: A Systematic Review and Meta-Analysis. Microorganisms. 2023 May 12;11(5):1272. doi: 10.3390/microorganisms11051272.
- Background: PubMed 35479587Rapoport EA, Baig M, Puli SR. Adverse events in fecal microbiota transplantation: a systematic review and meta-analysis. Ann Gastroenterol. 2022 Mar-Apr;35(2):150-163. doi: 10.20524/aog.2022.0695. Epub 2022 Feb 14.
- Background: PubMed 39391303Karimi M, Shirsalimi N, Hashempour Z, Salehi Omran H, Sedighi E, Beigi F, Mortezazadeh M. Safety and efficacy of fecal microbiota transplantation (FMT) as a modern adjuvant therapy in various diseases and disorders: a comprehensive literature review. Front Immunol. 2024 Sep 26;15:1439176. doi: 10.3389/fimmu.2024.1439176. eCollection 2024.
- Background: PubMed 39966520Diener C, Holscher HD, Filek K, Corbin KD, Moissl-Eichinger C, Gibbons SM. Metagenomic estimation of dietary intake from human stool. Nat Metab. 2025 Mar;7(3):617-630. doi: 10.1038/s42255-025-01220-1. Epub 2025 Feb 18.
- Background: PubMed 39058118Amchova P, Siska F, Ruda-Kucerova J. Food Safety and Health Concerns of Synthetic Food Colors: An Update. Toxics. 2024 Jun 27;12(7):466. doi: 10.3390/toxics12070466.
- Background: PubMed 33722860Asnicar F, Leeming ER, Dimidi E, Mazidi M, Franks PW, Al Khatib H, Valdes AM, Davies R, Bakker E, Francis L, Chan A, Gibson R, Hadjigeorgiou G, Wolf J, Spector TD, Segata N, Berry SE. Blue poo: impact of gut transit time on the gut microbiome using a novel marker. Gut. 2021 Sep;70(9):1665-1674. doi: 10.1136/gutjnl-2020-323877. Epub 2021 Mar 15.
- Background: PubMed 30075573Chehri M, Christensen AH, Halkjaer SI, Gunther S, Petersen AM, Helms M. Case series of successful treatment with fecal microbiota transplant (FMT) oral capsules mixed from multiple donors even in patients previously treated with FMT enemas for recurrent Clostridium difficile infection. Medicine (Baltimore). 2018 Aug;97(31):e11706. doi: 10.1097/MD.0000000000011706.
- Background: PubMed 30946615Cold F, Browne PD, Gunther S, Halkjaer SI, Petersen AM, Al-Gibouri Z, Hansen LH, Christensen AH. Multidonor FMT capsules improve symptoms and decrease fecal calprotectin in ulcerative colitis patients while treated - an open-label pilot study. Scand J Gastroenterol. 2019 Mar;54(3):289-296. doi: 10.1080/00365521.2019.1585939. Epub 2019 Apr 4.
- Background: PubMed 29980607Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.
- Background: PubMed 35088703Cold F, Svensson CK, Christensen AH, Gunther S, Petersen AM, Hansen LH, Helms M. Successful treatment of Clostridioidesdifficile infection with single-donorfaecal microbiota transplantation capsules. Dan Med J. 2022 Jan 20;69(2):A09210712.
- Background: PubMed 33091745Knowles KA, Olatunji BO. Specificity of trait anxiety in anxiety and depression: Meta-analysis of the State-Trait Anxiety Inventory. Clin Psychol Rev. 2020 Dec;82:101928. doi: 10.1016/j.cpr.2020.101928. Epub 2020 Oct 10.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because of data protection and privacy considerations. The study data will be handled and analyzed by the authorized researchers involved in the study in accordance with applicable data protection regulations.
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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.
Kenneth Klingenberg Barfod, Associate Professor, MSc, PhD contact
Dorte Bonde Zilstorff, MD contact
Andreas Munk Petersen, Professor, MD, PhD, DMSc principal investigator
Gastrounit, Medical Section and Department of Clinical Microbiology, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark, and Department of Clinical Medicine, University of Copenhagen, Denmark
Kenneth Klingenberg Barfod, Associate Professor, MSc, PhD study director
Food Microbiology, Gut Health and Fermentation, Department of Food Science (FOOD), University of Copenhagen, Denmark
Nadia Micali, Professor, MD, MRCPsych, PhD study chair
Center for Eating and feeding Disorders Research (CEDaR), Specialist center for Eating Disorders for the Capital Region , Copenhagen University Hospital Herlev and Gentofte Hospital, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation Capsule in people with Anorexia Nervosa, run by Andreas Munk Petersen at 2 sites in Denmark.
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 7 inclusion and 9 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
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 Kenneth Klingenberg Barfod, Associate Professor, MSc, PhD (004535325208, kenneth.barfod@food.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gut Microbiome Composition (T0-T1) (time frame: Baseline (T0) - After first 5 weeks (T1)). 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 NCT07877675, which also lists 61 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 16 Oct 2026.