FMT 对伴有和不伴有 IBS 的 MDD 患者的神经认知影响
2023年11月27日 更新者：Valerie Taylor
了解粪便微生物群移植对伴或不伴肠易激综合征的重度抑郁症患者的神经认知影响
这项研究是一项 2/3 期开放标签对照试验 (CT)，其中患有重度抑郁症 (MDD) 的成年人和患有 MDD 并伴有炎症性肠综合征 (IBS) 的成年人将被分配接受口服粪便微生物群移植 ( FMT）或继续他们目前在常规治疗（TAU）组中接受的治疗。 接受 TAU 的单独 IBS 组将被招募为临床对照组。
本研究的主要目标是确定口服 FMT 在患有 MDD 的成年人和患有 IBS 的 MDD 患者中的有效性、安全性和耐受性。 其他目标是描述与 MDD 和 MDD + IBS 相关的认知和神经关联的模式和进展，并确定它们是否通过 FMT 得到改善。 众所周知，患有 MDD 的人以及患有 MDD 和 IBS 的人都表现出认知改变以及神经结构的变化，但这项研究旨在了解这些是否随着对 FMT 的治疗反应而改变。”
研究概览
研究类型
介入性
注册 (估计的)
180
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Stefanie Hassel, PhD
- 电话号码：4032106430
- 邮箱：shassel@ucalgary.ca
研究联系人备份
- 姓名：Asem Bala, MSc
- 电话号码：4032107282
- 邮箱：asem.bala@ucalgary.ca
学习地点
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Alberta
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Calgary、Alberta、加拿大、T2N 4Z6
- 招聘中
- University of Calgary, TRW building
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接触：
- Asem Bala, MSc
- 邮箱：asem.bala@ucalgary.ca
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
描述
纳入标准：
18-60岁之间：
参加者在筛选当天应年满 18 岁且不超过 60 岁
- 由 M.I.N.I. 评估/确认初步诊断为 MDD。 国际神经精神病学访谈（MINI）
- 对至少 2 种批准的抗抑郁药有充分的证据证明反应不足
- 筛选和访视 2a 时 MADRS 评分≥ 19
- 有 IBS 的合并症诊断。 IBS 患者可包括以下任何一种：以腹泻为主的 IBS (IBS-D)、以便秘为主的 IBS (IBS-C)、具有混合排便习惯的 IBS (IBS-M) 或未分类的 IBS (IBS-U)使用 ROME III 标准的转诊医生
- 中度至重度 IBS 症状，IBS 严重程度评分系统 (IBS-SSS) 评分≥175
排除标准：
根据 M.I.N.I，参与者符合精神障碍诊断和统计手册 (DSM-5)[1] 对以下条件的标准：
- 最近 3 个月内有物质使用障碍。 *（标准应包括酒精和非酒精物质，大麻除外）
- 过去 3 个月因吸食大麻而出现中度或重度物质使用障碍
- 活动性神经性厌食症或神经性贪食症
- 精神分裂症、分裂情感性或双相情感障碍
- 主动自杀
- 在进入研究前的三 (3) 个月内定期服用非甾体类抗炎药、抗生素或铁补充剂用于医疗目的
- 在过去三 (3) 个月内出于医疗目的使用益生元或益生菌超过两 (2) 周
- 引起免疫抑制的情况
- 在本研究过程中正在哺乳、怀孕或打算怀孕的妇女。 不使用可接受的节育方法（植入物、注射剂、复方口服避孕药、宫内节育器、性禁欲或输精管切除术的伴侣）
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：接受 TAU 确诊为 MDD 的参与者
符合条件且同意的患者将按 1:1 的比例分配，以接受来自健康供体的 FMT 或继续他们通常的 MDD 药物治疗，即照常治疗 (TAU)。
这只手臂将继续接受他们通常使用的抗抑郁药。
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有源比较器：确诊为 MDD 的参与者将接受 FMT + TAU
符合条件且同意的患者将按 1:1 的比例分配，以接受来自健康供体的 FMT 或继续他们通常的 MDD 药物治疗，即照常治疗 (TAU)。
这支手臂将被分配接受由健康捐赠者提供的 FMT。
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FMT 是一种将肠道微生物群从经过筛选的健康供体转移到患者体内的技术，目的是在肠道中引入或恢复稳定的微生物群落。
其他名称：
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无干预：确认诊断为 MDD + IBS 的参与者被分配继续 TAU
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有源比较器：确诊为 MDD + IBS 的参与者被分配接受 FMT + TAU
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FMT 是一种将肠道微生物群从经过筛选的健康供体转移到患者体内的技术，目的是在肠道中引入或恢复稳定的微生物群落。
其他名称：
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无干预：确诊为 IBS 的参与者仅接受 TAU
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无干预：健康对照
来自健康比较 (HC) 参与者的数据将从另一项已完成的研究中提取。
将选择与当前试验中注册的患者人群最匹配且同意数据共享的健康比较参与者。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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蒙哥马利-奥斯伯格抑郁量表 (MADRS)
大体时间：第 13 周的基线
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一份包含 10 个项目的调查问卷，精神科医生用来衡量情绪障碍患者抑郁发作的严重程度。 这将用于评估辅助口服 FMT 与 TAU 和目前接受的 MDD 批准疗法相比的有效性。 MADRS 总分介于 0 到 60 之间。 每个项目产生 0 到 6 的分数，较高的 MADRS 分数表示更严重的抑郁症 |
第 13 周的基线
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IBS 症状严重程度量表 (IBS-SSS)
大体时间：第 13 周的基线
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IBS-SSS 是一份 5 项问卷，用于评估过去 10 天内腹痛的严重程度和频率、腹胀的严重程度、对排便习惯的不满以及对生活质量的干扰。 IBS-SSS 的分数范围从 0 到 500，分数越高表示症状越严重。 受试者可分为轻度 (75-175)、中度 (175-300) 或重度 (>300) IBS。 |
第 13 周的基线
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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多伦多副作用量表 (TSES)
大体时间：第 13 周的基线
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TSES 是一个包含 32 项的工具，旨在确定 CNS、GI 和性副作用的发生率、频率和严重程度。
对于每种副作用，频率和严重程度均以 5 分制衡量。
强度是通过将频率和严重程度相乘来衡量的。
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第 13 周的基线
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IBS 特定生活质量 (IBS-QoL)
大体时间：第 13 周的基线
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是一种自我报告的 34 项工具，用于评估 IBS 及其治疗的影响。 用于检查 IBS 患者的 GI 耐受性。 将对 34 个项目的个人反应相加并取平均值作为总分，然后转换为 0-100 等级以便于解释，较高的分数表示更好的 IBS 特定生活质量。 |
第 13 周的基线
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核磁共振 (NMR) 光谱法
大体时间：第 13 周的基线
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评估 FMT 对微生物组概况（群落结构和功能宏基因组）的影响。
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第 13 周的基线
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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结构和功能神经影像学
大体时间：第 13 周的基线
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fMRI 检查大脑成像变化对 FMT 的反应
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第 13 周的基线
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Valerie Taylor, MD, PhD、University of Calgary
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年4月6日
初级完成 (估计的)
2024年7月1日
研究完成 (估计的)
2024年12月1日
研究注册日期
首次提交
2021年12月13日
首先提交符合 QC 标准的
2021年12月13日
首次发布 (实际的)
2021年12月30日
研究记录更新
最后更新发布 (实际的)
2023年11月28日
上次提交的符合 QC 标准的更新
2023年11月27日
最后验证
2023年11月1日
更多信息
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肠易激综合症的临床试验
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Sanford HealthNational Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins Research Foundation; Cornelia... 和其他合作者招聘中线粒体疾病 | 色素性视网膜炎 | 重症肌无力 | 嗜酸性胃肠炎 | 多系统萎缩 | 平滑肌肉瘤 | 脑白质营养不良 | 肛瘘 | 脊髓小脑性共济失调3型 | 弗里德赖希共济失调 | 肯尼迪病 | 莱姆病 | 噬血细胞性淋巴组织细胞增生症 | 脊髓小脑性共济失调1型 | 脊髓小脑性共济失调2型 | 脊髓小脑共济失调6型 | 威廉姆斯综合症 | 先天性巨结肠症 | 糖原贮积病 | 川崎病 | 短肠综合症 | 低磷血症 | Leber先天性黑蒙 | 口臭 | 贲门失弛缓症 | 多发性内分泌肿瘤 | 利综合症 | 艾迪生病 | 多发性内分泌肿瘤 2 型 | 硬皮病 | 多发性内分泌肿瘤 1 型 | 多发性内分泌肿瘤 2A 型 | 多发性内分泌肿瘤 2B 型 | 非典型溶血性尿毒症综合征 | 胆道闭锁 | 痉挛性共济失调 | WAGR综合症 | 无虹膜 | 短暂性失忆症 | 马尾综合症 | Refsum 疾病 | 复发性呼吸... 及其他条件美国, 澳大利亚