The Fecal Microbiome Transplant (FMT) Study for Anorexia Nervosa
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Anorexia Nervosa. Базовые параметры: 16 лет — 35 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Fecal Microbiome Transplant to Normalize Gut Microbiota, Metabolomics, Immunology, Cognitive and Affective Processing in Patients Suffering From Anorexia Nervosa
Обзор
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.
Подробное описание
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:
1. FMT will result in a sustained increase diversity of microbes with the metabolomic characteristics of increased short-chain fatty acids and bacteriophage composition compared with pre-treatment, as determined by targeted metabolomic approaches. 2. FMT will improve immune profiles, reducing IL6, IL1b and the proportion of Th17 cells, along with an increase in repair cytokines such as TARC, IL4, IL13 and BDNF and Th2 cells. 3. FMT will significantly improve cognitive and affective functioning, including task-switching efficiency, food aversion and obsessional thinking about weight, punishment and reward sensitivity, depression and anxiety symptomatology, and AN symptom severity.
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.
Первичные конечные точки
- Feasibility of Intervention [Срок оценки: 1, 3, and 12 weeks post intervention]
Вторичные конечные точки (12)
- Shannon's Diversity Index [Срок оценки: Pre-intervention, 12 weeks post-intervention]
- Activated blood cells producing Th17/Th2 cytokines [Срок оценки: Pre-intervention, and 12-weeks post intervention]
- Activated blood cells producing BDNF [Срок оценки: Pre-intervention and 12-weeks post-intervention]
- RNA levels [Срок оценки: Pre-intervention and 12-weeks post-intervention]
- Task-switching Efficiency [Срок оценки: Pre-intervention, and 12 weeks post-intervention]
- Punishment sensitivity and reward sensitivity [Срок оценки: Pre-intervention and 12-weeks post-intervention]
- Depression [Срок оценки: Pre-intervention, and at 1-, 3-, 12-weeks post intervention]
- Depression [Срок оценки: Pre-intervention, and at 1-, 3-, 12-weeks post intervention]
- Anxiety [Срок оценки: Pre-intervention, and at 1-, 3-, 12-weeks post intervention]
- Anxiety [Срок оценки: Pre-intervention, and at 1-, 3-, 12-weeks post intervention]
- Eating Attitudes [Срок оценки: Pre-intervention, and 1-, 3-, 12-weeks post intervention]
- Anorexia Nervosa Symptoms [Срок оценки: Pre-intervention, and at 1-, 3-, 12-weeks post intervention]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Канада · 1 центр
- London Health Sciences Research Institute — London
Идентификаторы
NCT: NCT07143981 · ANFMT-001