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| Name | Class |
|---|---|
| Western University, Canada | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Receiving FMT |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Wammes | Contact | 519-646-6000 | 65196 | michael.wammes@lhsc.on.ca |
| Medina Meddaoui | Contact | medina.meddaoui@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Osuch | London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Research Institute | Recruiting | London | Ontario | N6J 1A2 | Canada |
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| Label | URL |
|---|---|
| Provides theoretical support for this project | View source |
| Provides theoretical support for this project | View source |
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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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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D000092862 | Psychological Well-Being |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D012817 | Signs and Symptoms, Digestive |
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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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |