About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Activated blood cells producing BDNF
Activated blood cells producing BDNF measured by Enzyme-Linked Immunosorbent Assay (ELISA)
RNA levels
RT-PCR (reverse transcription-polymerase chain reaction) for RNA levels of CCR6, CRTh2, CCR4, CXCR5 (marker genes for Th17 and Th2 cells)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead sponsor
Western University, Canada
Collaborator