Anorexia NervosaNCT07143981
The Fecal Microbiome Transplant (FMT) Study for Anorexia Nervosa
An observational study of Anorexia Nervosa, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Anorexia Nervosa (AN) is a severe, debilitating and potentially life threatening illness that is difficult to treat. A cardinal symptom of AN is the mistaken belief on the part of the individuals that they are overweight and must continue to restrict intake. This fixed false belief is a detrimental factor to recovery. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2026to 31 Aug 2027
- Phase
- Observational
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants in this study will be awaiting treatment for anorexia nervosa at London Health Sciences Centre's (LHSC, Ontario Canada) Adult Eating Disorders Service (AEDS).
Who may be able to join
- meet DSM 5 criteria for AN, restricting type, moderate or higher severity, as indicated by a BMI<17
- Participants must we willing and able to swallow FMT capsules without vomiting
- Able to read and understand conversational English
Who cannot join
- Medical or psychiatric instability needing hospitalization
- Patients with AN binge/purge type
- Use of antibiotics or probiotics in the month prior to treatment
- Regular oral steroid use, or potent topical steroid use on large sections of skin
- Chronic immune compromise and chronic illness affecting the intestinal tract or metabolic health
- Pregnancy or intended pregnancy over the time of study
- Patients enrolled in any treatment program that involves refeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medina Meddaoui contact
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Research Institute
London, Ontario, N6J 1A2
Beth Osuch, 519-685-8500 ext. 65188, elizabeth.osuch@lhsc.on.ca
About this study
Official title: Fecal Microbiome Transplant to Normalize Gut Microbiota, Metabolomics, Immunology, Cognitive and Affective Processing in Patients Suffering From Anorexia Nervosa
Anorexia Nervosa (AN) is a severe, debilitating and potentially life threatening illness that is difficult to treat. A cardinal symptom of AN is the mistaken belief on the part of the individuals that they are overweight and must continue to restrict intake. This fixed false belief is a detrimental factor to recovery. It is known that AN involves disturbance in the gut microbiome (GM; the microbes that live in the lower intestinal tract). The GM also affects how one thinks and makes food choices - there appears to be a direct link between the GM and how the brain functions. This connection is thought to occur through chemical processes that convey information from the gut to the brain. It is known that fecal microbiome transplant (FMT) has been useful in treating several illnesses, including several mental illnesses. The investigators intend to deliver FMT to individuals with AN to determine the extent to which this modifies their GM, their biochemistry, their thinking processes and their moods and emotions. The investigators believe this will illuminate important aspects of AN that keep the illness in place, and that this will uncover useful approaches to better treat it.
Read the detailed description
The overall objective is to determine FMT's acceptability and the extent and means by which it helps patients with AN, restricting type. The investigators hypothesize that FMT will lead to diversification of the GM, improved metabolic and immunological status and reduced cognitive and psychiatric symptoms in patients with AN, details never investigated before. This will be due to FMT's ability to impart healthy microorganisms into the lower intestines and, thereby, improve GBM-axis signaling that may contribute to maintaining AN. The investigators propose that this will result in measurable improvement in cognitive distortions about weight, leading to reduced AN symptomatology, breaking the weight loss/AN cycle.
Specific Aims \& Hypotheses
This is a one-group, pre-/post-intervention trial of FMT in AN-restricting type, with 1-week, 3-week and 3-month follow up, administered before specialized eating disorders treatment. The hypotheses are:
- FMT will result in a sustained increase diversity of microbes with the metabolomic characteristics of increased short-chain fatty acids and bacteriophage composition compared with pre-treatment, as determined by targeted metabolomic approaches.
- FMT will improve immune profiles, reducing IL6, IL1b and the proportion of Th17 cells, along with an increase in repair cytokines such as TARC, IL4, IL13 and BDNF and Th2 cells.
- FMT will significantly improve cognitive and affective functioning, including task-switching efficiency, food aversion and obsessional thinking about weight, punishment and reward sensitivity, depression and anxiety symptomatology, and AN symptom severity.
This is a prospective, longitudinal, single-arm, pre-post intervention. Variables will be compared using repeated-measures analyses with each participant as their own comparator.
- Conditions
- Anorexia Nervosa
- Keywords
- Microbiome, Fecal transplant, Gut microbiome, Gut brain axis, Mental health, Eating Disorders
- Medical subject headings
- Anorexia Nervosa, Psychological Well-Being, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Receiving FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention
Success will be evaluated using recruitment and retention rates, adverse event rates, and missing data rates. Scores at 75% or above will indicate high tolerability for this population that is in desperate need of additional intervention options.
Measured: 1, 3, and 12 weeks post intervention
Secondary outcomes (12)
Shannon's Diversity Index
Metric of microbiome diversity that considers richness of number of species and abundance. Higher values indicate more diversity. A value of 0 indicates that a community only has one species.
Measured: Pre-intervention, 12 weeks post-intervention
Activated blood cells producing Th17/Th2 cytokines
Activated blood cells producing Th17/Th2 cytokines by Luminex - IL6, IL1b, IL17, IL4, IL13 to evaluate immune responses.
Measured: Pre-intervention, and 12-weeks post intervention
Activated blood cells producing BDNF
Activated blood cells producing BDNF measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: Pre-intervention and 12-weeks post-intervention
RNA levels
RT-PCR (reverse transcription-polymerase chain reaction) for RNA levels of CCR6, CRTh2, CCR4, CXCR5 (marker genes for Th17 and Th2 cells)
Measured: Pre-intervention and 12-weeks post-intervention
Task-switching Efficiency
-Task-switching efficiency measured using the Cued Color-Shape Switching Task, CCSST. Accuracy and response time will be computed on both single-task blocks and mixed task blocks, where participants will need to switch between colour and shape responses. Switch costs and mixing costs will be calculated from these scores.
Measured: Pre-intervention, and 12 weeks post-intervention
Punishment sensitivity and reward sensitivity
Punishment sensitivity and reward sensitivity using the Behavioural Inhibition System/Behavioural Activation System Scales (BIS/BAS). There are three BAS scales in which higher scores equate to greater sensitivity to reward. There is one BIS scale for which higher scores equate to greater sensitivity to punishment.
Measured: Pre-intervention and 12-weeks post-intervention
Depression
Depression evaluated using the Montgomery Asberg Depression Rating Scale (MADRS). It is a 9-item scale where higher score indicates more severe depressive symptoms.
Measured: Pre-intervention, and at 1-, 3-, 12-weeks post intervention
Depression
Depression assessed with the Patient Health Questionnaire (PHQ-9), a 9-item scale evaluating the severity of depressive symptoms. Higher scores indicate more severe symptomatology.
Measured: Pre-intervention, and at 1-, 3-, 12-weeks post intervention
Anxiety
Anxiety assessed using the Spielberger State/Trait Anxiety Inventory (STAI)
Measured: Pre-intervention, and at 1-, 3-, 12-weeks post intervention
Anxiety
Anxiety assessed by the Generalized Anxiety Disorder 7-item scale (GAD-7)
Measured: Pre-intervention, and at 1-, 3-, 12-weeks post intervention
Eating Attitudes
-Food aversion and obsessional thinking about weight using the Eating Attitudes Test (EAT-26)
Measured: Pre-intervention, and 1-, 3-, 12-weeks post intervention
Anorexia Nervosa Symptoms
AN symptom severity with the Eating Disorders Examination Questionnaire (EDE-Q)
Measured: Pre-intervention, and at 1-, 3-, 12-weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start15 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada
- Responsible party
- Sponsor
- Investigators
- Elizabeth Osuch, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143981
- Sponsor's protocol ID
- ANFMT-001
- Status last verified
- Jan 2026
- First submitted
- 30 Jun 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small feasibility study. While we would not make personally identifiable information public, even the basic demographic information could be used to re-identify a participant. In light of the nature of this study we do not feel it is in the interest of our participants to share data on a repository.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiome Transplant to Normalize Gut Microbiota, Metabolomics, Immunology, Cognitive and Affective Processing in Patients Suffering From Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT07143981
- Acronym / sponsor ID
- ANFMT-001
- Conditions
- Anorexia Nervosa
- Keywords
- Microbiome, Fecal transplant, Gut microbiome, Gut brain axis, Mental health, Eating Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Western University, Canada
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Aug 2025 (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.
Anorexia Nervosa (AN) is a severe, debilitating and potentially life threatening illness that is difficult to treat. A cardinal symptom of AN is the mistaken belief on the part of the individuals that they are overweight and must continue to restrict intake. This fixed false belief is a detrimental factor to recovery. It is known that AN involves disturbance in the gut microbiome (GM; the microbes that live in the lower intestinal tract). The GM also affects how one thinks and makes food choices - there appears to be a direct link between the GM and how the brain functions. This connection is thought to occur through chemical processes that convey information from the gut to the brain. It is known that fecal microbiome transplant (FMT) has been useful in treating several illnesses, including several mental illnesses. The investigators intend to deliver FMT to individuals with AN to determine the extent to which this modifies their GM, their biochemistry, their thinking processes and their moods and emotions. The investigators believe this will illuminate important aspects of AN that keep the illness in place, and that this will uncover useful approaches to better treat it.
Detailed description
The overall objective is to determine FMT's acceptability and the extent and means by which it helps patients with AN, restricting type. The investigators hypothesize that FMT will lead to diversification of the GM, improved metabolic and immunological status and reduced cognitive and psychiatric symptoms in patients with AN, details never investigated before. This will be due to FMT's ability to impart healthy microorganisms into the lower intestines and, thereby, improve GBM-axis signaling that may contribute to maintaining AN. The investigators propose that this will result in measurable improvement in cognitive distortions about weight, leading to reduced AN symptomatology, breaking the weight loss/AN cycle.
Specific Aims \& Hypotheses
This is a one-group, pre-/post-intervention trial of FMT in AN-restricting type, with 1-week, 3-week and 3-month follow up, administered before specialized eating disorders treatment. The hypotheses are:
- FMT will result in a sustained increase diversity of microbes with the metabolomic characteristics of increased short-chain fatty acids and bacteriophage composition compared with pre-treatment, as determined by targeted metabolomic approaches.
- FMT will improve immune profiles, reducing IL6, IL1b and the proportion of Th17 cells, along with an increase in repair cytokines such as TARC, IL4, IL13 and BDNF and Th2 cells.
- FMT will significantly improve cognitive and affective functioning, including task-switching efficiency, food aversion and obsessional thinking about weight, punishment and reward sensitivity, depression and anxiety symptomatology, and AN symptom severity.
This is a prospective, longitudinal, single-arm, pre-post intervention. Variables will be compared using repeated-measures analyses with each participant as their own comparator.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment | – | –Receiving FMT |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants in this study will be awaiting treatment for anorexia nervosa at London Health Sciences Centre's (LHSC, Ontario Canada) Adult Eating Disorders Service (AEDS).
Key inclusion criteria (3 listed)
- meet DSM 5 criteria for AN, restricting type, moderate or higher severity, as indicated by a BMI<17
- Participants must we willing and able to swallow FMT capsules without vomiting
- Able to read and understand conversational English
Key exclusion criteria (7 listed)
- Medical or psychiatric instability needing hospitalization
- Patients with AN binge/purge type
- Use of antibiotics or probiotics in the month prior to treatment
- Regular oral steroid use, or potent topical steroid use on large sections of skin
- Chronic immune compromise and chronic illness affecting the intestinal tract or metabolic health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of Intervention
Time frame: 1, 3, and 12 weeks post intervention
Success will be evaluated using recruitment and retention rates, adverse event rates, and missing data rates. Scores at 75% or above will indicate high tolerability for this population that is in desperate need of additional intervention options.
12 secondary outcomes
Shannon's Diversity Index
Time frame: Pre-intervention, 12 weeks post-intervention
Activated blood cells producing Th17/Th2 cytokines
Time frame: Pre-intervention, and 12-weeks post intervention
Activated blood cells producing BDNF
Time frame: Pre-intervention and 12-weeks post-intervention
RNA levels
Time frame: Pre-intervention and 12-weeks post-intervention
Task-switching Efficiency
Time frame: Pre-intervention, and 12 weeks post-intervention
Punishment sensitivity and reward sensitivity
Time frame: Pre-intervention and 12-weeks post-intervention
Depression
Time frame: Pre-intervention, and at 1-, 3-, 12-weeks post intervention
Depression
Time frame: Pre-intervention, and at 1-, 3-, 12-weeks post intervention
Anxiety
Time frame: Pre-intervention, and at 1-, 3-, 12-weeks post intervention
Anxiety
Time frame: Pre-intervention, and at 1-, 3-, 12-weeks post intervention
Eating Attitudes
Time frame: Pre-intervention, and 1-, 3-, 12-weeks post intervention
Anorexia Nervosa Symptoms
Time frame: Pre-intervention, and at 1-, 3-, 12-weeks post intervention
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 23 Jan 2026.
- Provides theoretical support for this projectLink provided by the sponsor.
- Provides theoretical support for this projectLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is a small feasibility study. While we would not make personally identifiable information public, even the basic demographic information could be used to re-identify a participant. In light of the nature of this study we do not feel it is in the interest of our participants to share data on a repository.
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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.
Medina Meddaoui contact
Elizabeth Osuch principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 Michael Wammes (519-646-6000 ext. 65196, michael.wammes@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention (time frame: 1, 3, and 12 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2026.