Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07143981 for Anorexia Nervosa is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
The Fecal Microbiome Transplant (FMT) Study for Anorexia Nervosa 20 Microbiome
Clinical Trial NCT07143981 is an observational study for Anorexia Nervosa that is recruiting. It started on January 15, 2026 with plans to enroll 20 participants. Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, it is expected to complete by August 31, 2027. The latest data from ClinicalTrials.gov was last updated on January 23, 2026.
Brief 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. It is known that AN involves disturbance in the gut microbiome (GM; the microbes that live in the lo...Show More
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 micro...Show More
Official Title
Fecal Microbiome Transplant to Normalize Gut Microbiota, Metabolomics, Immunology, Cognitive and Affective Processing in Patients Suffering From Anorexia Nervosa
Conditions
Anorexia NervosaOther Study IDs
- ANFMT-001
NCT ID Number
Start Date (Actual)
2026-01-15
Last Update Posted
2026-01-23
Completion Date (Estimated)
2027-08-31
Enrollment (Estimated)
20
Study Type
Observational
Status
Recruiting
Keywords
Microbiome
Fecal transplant
Gut microbiome
Gut brain axis
Mental health
Eating Disorders
Fecal transplant
Gut microbiome
Gut brain axis
Mental health
Eating Disorders
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active treatment Receiving FMT | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 1, 3, and 12 weeks post intervention |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | Pre-intervention, and 12-weeks post intervention |
Activated blood cells producing BDNF | Activated blood cells producing BDNF measured by Enzyme-Linked Immunosorbent Assay (ELISA) | 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) | 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. | 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. | 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. | 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. | Pre-intervention, and at 1-, 3-, 12-weeks post intervention |
Anxiety | Anxiety assessed using the Spielberger State/Trait Anxiety Inventory (STAI) | Pre-intervention, and at 1-, 3-, 12-weeks post intervention |
Anxiety | Anxiety assessed by the Generalized Anxiety Disorder 7-item scale (GAD-7) | 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) | Pre-intervention, and 1-, 3-, 12-weeks post intervention |
Anorexia Nervosa Symptoms | AN symptom severity with the Eating Disorders Examination Questionnaire (EDE-Q) | Pre-intervention, and at 1-, 3-, 12-weeks post intervention |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
16 Years
Eligible Sexes
All
- 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
- 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
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sWestern University, CanadaStudy Central Contact
Contact: Michael Wammes, 519-646-6000, [email protected]
Contact: Medina Meddaoui, [email protected]
1 Study Locations in 1 Countries
Ontario
London Health Sciences Research Institute, London, Ontario, N6J 1A2, Canada
Beth Osuch, Contact, 519-685-8500, [email protected]
Recruiting