Bipolar disorder (BD) is a chronic, debilitating illness with significant medical morbidity, often secondary to current treatments, and a high recurrence rate. This burden of disease reflects limitations in the tolerability and efficacy of current treatments. There is a compelling body of evidence linking the gut microbiota to mental illness, and while microbial manipulation via probiotic use has been studied as a therapeutic in BD, targeted trials of fecal microbiota transplantation (FMT) have not been conducted in this population. We describe a pilot randomized controlled trial of FMT in participants with BD depression to assess the feasibility, efficacy, safety, and tolerability of this intervention. Individuals between 18 and 65 years of age will be enrolled in the study if they meet diagnostic criteria for a major depressive episode of at least moderate severity in the context of a BD diagnosis and have not responded to treatment for BD. Participants will be randomized 1:1 to receive either screened and processed donor stool (allogenic FMT) or their own stool (autologous FMT) via colonoscopy and monitored for 24 weeks post intervention. Depressive and manic symptoms, treatment acceptability, and gastrointestinal and other side effects are assessed at baseline (prior to randomization) and weekly. Stool samples to assess microbiome composition are obtained at baseline and 3 and 6 months. Currently, FMT represents a novel therapeutic option for treating BD depression. This protocol allows for the assessment of the feasibility, efficacy, acceptability, and safety of an intervention aimed at changing the microbiome in those with BD. Results from this pilot study will guide the development of larger trials of FMT for BD depression and may give more insight into how the gut microbiome are altered in those with BD depression. Clinical Trials Gov NCT03279224

中文翻译：

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粪便微生物群移植在抑郁发作期间双相情感障碍人群中的安全性和有效性：一项试点随机对照试验的研究方案

双相情感障碍 (BD) 是一种慢性、使人衰弱的疾病，具有显着的医疗发病率，通常继发于当前的治疗，并且复发率高。这种疾病负担反映了当前治疗的耐受性和有效性的局限性。有大量令人信服的证据将肠道微生物群与精神疾病联系起来，虽然通过益生菌使用微生物操纵已被研究作为 BD 的治疗方法，但尚未在该人群中进行粪便微生物群移植 (FMT) 的靶向试验。我们描述了一项对 BD 抑郁症参与者进行 FMT 的随机对照试验，以评估这种干预的可行性、有效性、安全性和耐受性。如果年龄在 18 至 65 岁之间的个体符合 BD 诊断背景下至少中等严重程度的重度抑郁发作的诊断标准，并且对 BD 治疗没有反应，则他们将被纳入研究。参与者将按照 1:1 的比例随机接受经过筛查和处理的供体粪便（同种异体 FMT）或他们自己的粪便（自体 FMT），通过结肠镜检查并在干预后 24 周内进行监测。在基线（随机化前）和每周评估抑郁和躁狂症状、治疗可接受性以及胃肠道和其他副作用。在基线和 3 个月和 6 个月时获得用于评估微生物组组成的粪便样本。目前，FMT 代表了治疗 BD 抑郁症的一种新的治疗选择。该协议允许评估可行性、有效性、旨在改变 BD 患者微生物组的干预措施的可接受性和安全性。这项试点研究的结果将指导针对 BD 抑郁症进行更大规模的 FMT 试验的发展，并可能更深入地了解 BD 抑郁症患者的肠道微生物组是如何改变的。临床试验政府 NCT03279224