Anorexia Nervosa Restricting TypeFMT-ANNCT06593366
Fecal Microbiota Transplant for Anorexia Nervosa
A study testing Fecal Microbiota Transplant in people with Anorexia Nervosa Restricting Type and Anorexia Nervosa, run by Hamilton Health Sciences Corporation.
Trial summary
The purpose of this pilot randomized-controlled trial is to determine whether Fecal Microbiota Transplant (FMT) treatment demonstrates feasibility, acceptability, and prelinary effectiveness among patients with anorexia nervosa (AN). Read more about this study
- Who is it for?
- Ages 12 to 17 years, women only
- Conditions the study is for
- Anorexia Nervosa Restricting Type, Anorexia Nervosa, Anorexia in Adolescence
- What is being tested?
- Fecal Microbiota Transplant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2027
- 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 12 to 17 years
- Women only
- No healthy volunteers
- Child
Inclusion Criteria: All study subjects will have been diagnosed with AN (restricting type or binge eating/purging type) by the primary physician on the ED team, as per standard approach. Study participants will:
- Be 12-17 years-old at time of recruitment
- Have capacity to consent
- Be assigned female sex at birth (may be gender diverse)
- Be active patients in the pediatric ED program at MCH
- Have a weight that is <85% of the Treatment Goal Weight, as determined by the treating physician
Exclusion Criteria: Potential study subjects will be excluded due to the following reasons:
- Exposure to antibiotics within two weeks of study randomization
- Initiation of new probiotics / oral nutritional supplements within two weeks of randomization
- Active pregnancy
- Active psychosis or suicidal ideation
- Other comorbidities that may affect weight or the gut microbiome including celiac disease, inflammatory bowel disease (or other conditions as determined by the study team)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Pilot Feasibility Randomized Controlled Trial of Fecal Microbiota Transplant for Adolescent Anorexia Nervosa
The purpose of this pilot randomized-controlled trial is to determine whether Fecal Microbiota Transplant (FMT) treatment demonstrates feasibility, acceptability, and prelinary effectiveness among patients with anorexia nervosa (AN). Specifically, the investigators aim to compare changes in weight, gut microbiome, urine, blood biomarkers and mood symptoms between participants receiving the FMT intervention and placebo.
Read the detailed description
In the following pilot randomized-controlled trial, the investigators' aim is to determine whether FMT treatment demonstrates feasibility, acceptability, and preliminary effectiveness in pediatric AN participants. The investigators will assess how the use of FMT affects participants' rate of weight restoration, gut microbiome, relevant urine and blood biomarkers, and mood symptoms. The investigators' rationale for performing the study is to better understand the interactions between the intestinal microbiome, energy regulation, and behavior. This will be the first study to assess the role of FMT in pediatric AN and will help establish whether this adjunctive treatment modality has benefit in managing the metabolic and behavioral manifestations of this complex neuropsychiatric disorder.
In terms of study procedures, members of a pilot sample of 20 AN patients recruited from McMaster Children's Hospital will be randomized to receive FMT or placebo. All participants will be asked to complete a battery of assessments at regular intervals over the 8-week intervention period, and at a follow-up point at four weeks post-intervention.
The study's primary outcomes are recruitment and retention rates. Descriptive statistics will be used to determine the number of adolescents who will agree to participate in the study and those who will complete the study.
One of the study's secondary outcomes is participants' attitudes toward FMT. This will be measured through qualitative interviews among those who completed the intervention and those who do not agree to participate in the study.
The investigators will know we have reached saturation by using a method called "information power" and will explore how broad the research questions are, if there are clear theories to guide the analysis, how varied the participants in the study are, and how much useful information is accrued. Based on this, the investigators will determine the appropriate number of interviews to lead.
The remaining secondary outcome is a battery of preliminary outcomes (clinical, biological, biochemical and safety). The investigators will assess these outcomes at multiple timepoints using questionnaires, anthropometric data, stool analysis (16s rRNA), urine metabolic analysis, saliva ultra filtrates, changes in blood work, and common terminology criteria for adverse events for safety outcomes.
- Conditions
- Anorexia Nervosa Restricting Type, Anorexia Nervosa, Anorexia in Adolescence, Anorexia in Children, Anorexia
- Being tested
- Fecal Microbiota Transplant, Placebo
- Keywords
- anorexia nervosa, fecal microbiota transplant, pilot study, randomized controlled trial, feasibility
- Medical subject headings
- Anorexia Nervosa, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantBiological
An investigational biologic comprised of 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule, to be taken twice per day, twice per week over an 8-week duration.
PlaceboDrug
Oral placebo capsules (OPC) containing methylcellulose, to be taken twice per day, twice per week over an 8-week duration.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplant | Active comparator | Banked donor stools that have been previously screened, prepared and frozen per previous protocols will be used to prepare all oral FMT capsules (OFC) through the laboratory of a collaborator. Recipients will receive OFC (two capsules, twice a day, twice per week) prepared from a single donor throughout their 8-week treatment course, to support assessment of FMT engraftment in recipients; this totals to 64 capsules across the duration of the study. Each OFC will contain approximately 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule. Receives: Biological: Fecal Microbiota Transplant |
| Placebo | Placebo comparator | Matching oral placebo capsules (OPC) containing methylcellulose will be identical in terms of size, colour, taste, and dosing. Participants will be asked to take the Placebo treatment capsules twice a day for two days per week for a duration of eight weeks (total 64 capsules). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
The number of participants who are consented into the study divided by the number of participants who show interest in the study.
Measured: Through study completion, an average of one year.
Retention Rate
The number of participants who completed the study divided by the number of participants consented into the study.
Measured: Through study completion, an average of one year.
Secondary outcomes (21)
Attitudes towards Fecal Microbiota Transplant
Attitudes towards FMT will be studied via semi-structured qualitative interviews of all participants: the 20 adolescents and their parents in the trial, and the 10 adolescents and their parents who decline participation, and their guardians. Using Qualitative Description, interviews will explore patient and guardian attitudes toward FMT, as well as their impressions of efficacy (if they participated in the trial). Questions will include perceptions of "natural" versus "drug" products, perspectives on causes of AN, and interests in other potential treatments. Interviews will be conducted virtually, using Zoom for Healthcare, transcribed verbatim and then coded for themes using NVivo. This analysis stays close to the data with little to no interpretation. Our analysis will also include a summative content analysis.
Measured: Week 12 (follow-up)
Height
Height will be collected.
Measured: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Weight
Weight will be measured between hospital visits using home weight scales provided to study participants.
Measured: Week 0 (baseline), Week 2, Week 4 (mid-treatment), Week 6, Week 8 (post-intervention), Week 10, Week 12 (follow-up)
Eating Disorder Examination Questionnaire
The EDEQ is a 28-item standardized questionnaire that measures the severity of symptoms of eating disorders, including menstrual status.
Measured: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Beck Depression Inventory
The BDI is a 21-item questionnaire used to measure the severity of depressive symptoms.
Measured: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Beck Anxiety Inventory
The BAI is a 21-item questionnaire used to measure the severity of anxiety symptoms.
Measured: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Yale-Brown-Cornell Eating Disorder Scale
The YBC-EDS assesses impairment, persistence and degree of obsessional thinking and compulsiveness about eating behaviors.
Measured: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Gastrointestinal Symptom Rating Scale
This is a 15-item rating scale to capture a variety of GI symptoms.
Measured: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Changes in stool metabolites
Stool will be collected in to examine changes in alpha- and beta- diversity of microbiota, as well as engraftment of donor specific strains/genes and microbially-derived metabolite levels throughout the study. All stool samples will be collected using an at-home collection kit. Samples will be collected and stored in locked, secure -80°C study freezers upon being brought to the hospital or shipped by paid courier by participants. Stool samples will be sequenced for 16s rRNA gene profiling. All 16s rRNA analyses will be performed using in-house bioinformatics pipelines through the laboratory of a collaborator to identify amplicon sequence variants, perform taxonomic assignments, and analyze alpha- and beta-diversity and differential taxonomic abundance.
Measured: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Changes in urine metabolomics
Urine samples will be collected from each participant. Nontargeted metabolite profiling is a method used to explore and identify as many metabolites as possible in a sample to identify whatever is present. This approach is designed to help discover new metabolites, and identify changes in metabolite levels that may correlate with other outcomes. We will report differences in highest-abundance metabolites using t-tests to compare their presence between groups, and correlation coefficients to identify associations between outcomes.
Measured: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Changes in saliva ultrafiltrates
Saliva samples will be collected for metabolomic analysis. Saliva ultrafiltrates will be analyzed as described above for stool and urine samples by a collaborator. All saliva ultrafiltrates will be reported using the same multisegment injection-capillary electrophoresis-mass spectrometer, where metabolites are reported using effect sizes to compare relative concentrations against reference standards.
Measured: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Changes in complete blood count
Using the provided blood samples, changes in complete blood count from baseline to post-intervention will be compared using paired t-tests. The complete blood count includes (with their measurement units):
Red blood count (RBC)- cells/L Hemoglobin (Hb)- g/L Hematocrit- L/L Mean corpuscular volume (MCV)- fL Mean Corpuscular Hemoglobin (MCH)- pg Mean corpuscular hemoglobin concentration (MCHC)- g/L Red cell distribution width (RDW)- % White blood count (WBC) - cells/L Neutrophils - cells/L Lymphocytes - cells/L Eosinophils - cells/L Basophils - cells/L Monocytes - cells/L
Measured: Week 0 (baseline), Week 8 (post-intervention)
Changes in C-reactive protein
Using the provided blood samples, changes in C-reactive protein (CRP) from baseline to post-intervention will be compared using paired t-tests. CRP (measured in mg/L) is used to monitor inflammation in acute or chronic conditions.
Measured: Week 0 (baseline), Week 8 (post-intervention)
Changes in alkaline phosphatase
Using the provided blood samples, changes in alkaline phosphatase (ALP) from baseline to post-intervention will be compared using paired t-tests. ALP (measured in U/L) is associated with liver function.
Measured: Week 0 (baseline), Week 8 (post-intervention)
Changes in alanine aminotransferase
Using the provided blood samples, changes in alanine aminotransferase (ALT) from baseline to post-intervention will be compared using paired t-tests. ALT (measured in U/L) is associated with liver function.
Measured: Week 0 (baseline), Week 8 (post-intervention)
Changes in 25-OH Vitamin D
Using the provided blood samples, changes in 25-OH Vitamin D from baseline to post-intervention will be compared using paired t-tests. 25-OH Vitamin D (measured in ng/ml) is used as a measure of Vitamin D levels.
Measured: Week 0 (baseline), Week 8 (post-intervention)
Changes in albumin
Using the provided blood samples, changes in albumin from baseline to post-intervention will be compared using paired t-tests. Albumin (measured in g/L) is associated with liver and kidney function.
Measured: Week 0 (baseline), Week 8 (post-intervention)
Changes in follicle stimulating hormone
Using the provided blood samples, changes in follicle stimulating hormone (FSH) from baseline to post-intervention will be compared using paired t-tests. FSH (measured in mIU/mL) is important for determining aspects of fertility and menstruation.
Measured: Week 0 (baseline), Week 8 (post-intervention)
Changes in luteinizing hormone
Using the provided blood samples, changes in luteinizing hormone (LH) from baseline to post-intervention will be compared using paired t-tests. LH (measured in IU/L) is important for determining aspects of fertility and menstruation.
Measured: Week 0 (baseline), Week 8 (post-intervention)
Changes in free testosterone
Using the provided blood samples, changes in free testosterone from baseline to post-intervention will be compared using paired t-tests. Free testosterone (measured in nmol/L) is important for assessing various bodily functions related to hormones.
Measured: Week 0 (baseline), Week 8 (post-intervention)
Presence of safety outcomes
Common Terminology Criteria for Adverse Events (CTCAE) will be used to define adverse events and serious adverse events. This framework will be used to classify broad safety concerns throughout our trial.
Measured: Through study completion, an average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia Nervosa Restricting TypeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Hamilton Academic Health Sciences Organization
- Responsible party
- Sponsor
- Investigators
- Jennifer L Couturier, MD, MSc, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593366
- Sponsor's protocol ID
- FMTAN
- Acronym
- FMT-AN
- Status last verified
- May 2026
- First submitted
- 26 Jul 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data to other researchers.
Publications
Couturier J, Kenner E, Nicula M, Chowdhury F, Surette M, Pai N. Protocol for a pilot feasibility randomised controlled trial of fecal microbiota transplantation for adolescent anorexia nervosa. BMJ Open. 2026 Apr 20;16(4):e109115. doi: 10.1136/bmjopen-2025-109115.
PubMed 42009386
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Randomized Controlled Trial of Fecal Microbiota Transplant for Adolescent Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT06593366
- Acronym / sponsor ID
- FMT-AN / FMTAN
- Conditions
- Anorexia Nervosa Restricting Type, Anorexia Nervosa, Anorexia in Adolescence, Anorexia in Children, Anorexia
- Keywords
- anorexia nervosa, fecal microbiota transplant, pilot study, randomized controlled trial, feasibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University, Hamilton Academic Health Sciences Organization
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 Sep 2024 (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 purpose of this pilot randomized-controlled trial is to determine whether Fecal Microbiota Transplant (FMT) treatment demonstrates feasibility, acceptability, and prelinary effectiveness among patients with anorexia nervosa (AN). Specifically, the investigators aim to compare changes in weight, gut microbiome, urine, blood biomarkers and mood symptoms between participants receiving the FMT intervention and placebo.
Detailed description
In the following pilot randomized-controlled trial, the investigators' aim is to determine whether FMT treatment demonstrates feasibility, acceptability, and preliminary effectiveness in pediatric AN participants. The investigators will assess how the use of FMT affects participants' rate of weight restoration, gut microbiome, relevant urine and blood biomarkers, and mood symptoms. The investigators' rationale for performing the study is to better understand the interactions between the intestinal microbiome, energy regulation, and behavior. This will be the first study to assess the role of FMT in pediatric AN and will help establish whether this adjunctive treatment modality has benefit in managing the metabolic and behavioral manifestations of this complex neuropsychiatric disorder.
In terms of study procedures, members of a pilot sample of 20 AN patients recruited from McMaster Children's Hospital will be randomized to receive FMT or placebo. All participants will be asked to complete a battery of assessments at regular intervals over the 8-week intervention period, and at a follow-up point at four weeks post-intervention.
The study's primary outcomes are recruitment and retention rates. Descriptive statistics will be used to determine the number of adolescents who will agree to participate in the study and those who will complete the study.
One of the study's secondary outcomes is participants' attitudes toward FMT. This will be measured through qualitative interviews among those who completed the intervention and those who do not agree to participate in the study.
The investigators will know we have reached saturation by using a method called "information power" and will explore how broad the research questions are, if there are clear theories to guide the analysis, how varied the participants in the study are, and how much useful information is accrued. Based on this, the investigators will determine the appropriate number of interviews to lead.
The remaining secondary outcome is a battery of preliminary outcomes (clinical, biological, biochemical and safety). The investigators will assess these outcomes at multiple timepoints using questionnaires, anthropometric data, stool analysis (16s rRNA), urine metabolic analysis, saliva ultra filtrates, changes in blood work, and common terminology criteria for adverse events for safety outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplant | Active comparator | Biological: Fecal Microbiota TransplantBanked donor stools that have been previously screened, prepared and frozen per previous protocols will be used to prepare all oral FMT capsules (OFC) through the laboratory of a collaborator. Recipients will receive OFC (two capsules, twice a day, twice per week) prepared from a single donor throughout their 8-week treatment course, to support assessment of FMT engraftment in recipients; this totals to 64 capsules across the duration of the study. Each OFC will contain approximately 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule. |
| Placebo | Placebo comparator | Drug: PlaceboMatching oral placebo capsules (OPC) containing methylcellulose will be identical in terms of size, colour, taste, and dosing. Participants will be asked to take the Placebo treatment capsules twice a day for two days per week for a duration of eight weeks (total 64 capsules). |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 TransplantAn investigational biologic comprised of 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule, to be taken twice per day, twice per week over an 8-week duration. | Biological | Fecal Microbiota Transplant |
| PlaceboOral placebo capsules (OPC) containing methylcellulose, to be taken twice per day, twice per week over an 8-week duration. | Drug | Placebo |
Primary outcome
Recruitment Rate
Time frame: Through study completion, an average of one year.
The number of participants who are consented into the study divided by the number of participants who show interest in the study.
Retention Rate
Time frame: Through study completion, an average of one year.
The number of participants who completed the study divided by the number of participants consented into the study.
21 secondary outcomes
Attitudes towards Fecal Microbiota Transplant
Time frame: Week 12 (follow-up)
Height
Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Weight
Time frame: Week 0 (baseline), Week 2, Week 4 (mid-treatment), Week 6, Week 8 (post-intervention), Week 10, Week 12 (follow-up)
Eating Disorder Examination Questionnaire
Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Beck Depression Inventory
Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Beck Anxiety Inventory
Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Yale-Brown-Cornell Eating Disorder Scale
Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Gastrointestinal Symptom Rating Scale
Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Changes in stool metabolites
Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Changes in urine metabolomics
Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Changes in saliva ultrafiltrates
Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
Changes in complete blood count
Time frame: Week 0 (baseline), Week 8 (post-intervention)
Changes in C-reactive protein
Time frame: Week 0 (baseline), Week 8 (post-intervention)
Changes in alkaline phosphatase
Time frame: Week 0 (baseline), Week 8 (post-intervention)
Changes in alanine aminotransferase
Time frame: Week 0 (baseline), Week 8 (post-intervention)
Changes in 25-OH Vitamin D
Time frame: Week 0 (baseline), Week 8 (post-intervention)
Changes in albumin
Time frame: Week 0 (baseline), Week 8 (post-intervention)
Changes in follicle stimulating hormone
Time frame: Week 0 (baseline), Week 8 (post-intervention)
Changes in luteinizing hormone
Time frame: Week 0 (baseline), Week 8 (post-intervention)
Changes in free testosterone
Time frame: Week 0 (baseline), Week 8 (post-intervention)
Presence of safety outcomes
Time frame: Through study completion, an average of one year.
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 27 May 2026.
- Derived from this study: PubMed 42009386Couturier J, Kenner E, Nicula M, Chowdhury F, Surette M, Pai N. Protocol for a pilot feasibility randomised controlled trial of fecal microbiota transplantation for adolescent anorexia nervosa. BMJ Open. 2026 Apr 20;16(4):e109115. doi: 10.1136/bmjopen-2025-109115.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data to other researchers.
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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.
Jennifer L Couturier, MD, MSc principal investigator
Hamilton Health Sciences Corporation
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplant in people with Anorexia Nervosa Restricting Type and Anorexia Nervosa, run by Hamilton Health Sciences Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Jennifer L Couturier, MD, MSc (905-521-2100 ext. 76035, coutur@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Through study completion, an average of one year.). The study lists 2 primary outcomes in all. 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 NCT06593366, which also lists 1 linked publication.
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 27 May 2026.