The Fecal Microbiome Transplant (FMT) Study for Anorexia Nervosa

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-35
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20 Participants
are grouped into 1 trial group
Group A: Active treatment

Trial outcomes

Primary outcomes

1

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.

Time frame
1, 3, and 12 weeks post intervention

Secondary outcomes

1

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.

Time frame
Pre-intervention, 12 weeks post-intervention
2

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.

Time frame
Pre-intervention, and 12-weeks post intervention
3

Activated blood cells producing BDNF

Activated blood cells producing BDNF measured by Enzyme-Linked Immunosorbent Assay (ELISA)

Time frame
Pre-intervention and 12-weeks post-intervention
4

RNA levels

RT-PCR (reverse transcription-polymerase chain reaction) for RNA levels of CCR6, CRTh2, CCR4, CXCR5 (marker genes for Th17 and Th2 cells)

Time frame
Pre-intervention and 12-weeks post-intervention

Other outcomes

Sponsors and contacts

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