Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, Delhi, India.
Department of Pathology, All India Institute of Medical Sciences, New Delhi, Delhi, India.
Gut. 2022 Dec;71(12):2401-2413. doi: 10.1136/gutjnl-2022-327811. Epub 2022 Aug 16.
Microbiome and dietary manipulation therapies are being explored for treating ulcerative colitis (UC). We aimed to examine the efficacy of multidonor faecal microbiota transplantation (FMT) and anti-inflammatory diet in inducing remission followed by long-term maintenance with anti-inflammatory diet in patients with mild-moderate UC.
This open-labelled randomised controlled trial (RCT) randomised patients with mild-moderate (Simple Clinical Colitis Activity Index (SCCAI) 3-9) endoscopically active UC (Ulcerative Colitis Endoscopic Index of Severity (UCEIS)>1) on stable baseline medications in 1:1 ratio to FMT and anti-inflammatory diet (FMT-AID) versus optimised standard medical therapy (SMT). The FMT-AID arm received seven weekly colonoscopic infusions of freshly prepared FMT from multiple rural donors(weeks 0-6) with anti-inflammatory diet. Baseline medications were optimised in the SMT arm. Clinical responders (decline in SCCAI3) at 8 weeks in both arms were followed until 48 weeks on baseline medications (with anti-inflammatory diet in the FMT-AID arm). Primary outcome measures were clinical response and deep remission (clinical-SCCAI <2; and endoscopic-UCEIS <1) at 8 weeks, and deep remission and steroid-free clinical remission at 48 weeks.
Of the 113 patients screened, 73 were randomised, and 66 were included in (35-FMT-AID; 31-SMT) modified intention-to-treat analysis (age-35.7±11.1 years; male-60.1%; disease duration-48 (IQR 24-84) months; pancolitis-34.8%; SCCAI-6 (IQR 5-7); UCEIS-4 (IQR 3-5)). Baseline characteristics were comparable. FMT-AID was superior to SMT in inducing clinical response (23/35 (65.7%) vs 11/31 (35.5%), p=0.01, OR 3.5 (95% CI 1.3 to 9.6)), remission (21/35 (60%) vs 10/31 (32.3%), p=0.02, OR 3.2 (95% CI 1.1 to 8.7)) and deep remission (12/33 (36.4%) vs 2/23 (8.7%), p=0.03, OR 6.0 (95% CI 1.2 to 30.2)) at 8 weeks. Anti-inflammatory diet was superior to SMT in maintaining deep remission until 48 weeks (6/24 (25%) vs 0/27, p=0.007).
Multidonor FMT with anti-inflammatory diet effectively induced deep remission in mild-moderate UC which was sustained with anti-inflammatory diet over 1 year.
ISRCTN15475780.
微生物组和饮食干预疗法正在被探索用于治疗溃疡性结肠炎（UC）。我们旨在研究多供体粪便微生物群移植（FMT）和抗炎饮食在诱导轻度至中度 UC 患者缓解后的疗效，然后用抗炎饮食进行长期维持。
这是一项开放标签的随机对照试验（RCT），将轻度至中度（简单临床结肠炎活动指数（SCCAI）3-9）内镜活动 UC（溃疡性结肠炎内镜严重指数（UCEIS）>1）的患者随机分为 1:1 比例接受 FMT 和抗炎饮食（FMT-AID）与优化标准药物治疗（SMT）。FMT-AID 组在第 0-6 周接受每周 7 次结肠镜下新鲜制备的来自多个农村供体的 FMT（FMT），同时进行抗炎饮食。SMT 组优化了基础药物治疗。在第 8 周时，两组的临床应答者（SCCAI3 下降）继续接受治疗，直至第 48 周时继续接受基础药物治疗（FMT-AID 组继续进行抗炎饮食）。主要观察指标是第 8 周的临床应答和深度缓解（临床-SCCAI<2；和内镜-UCEIS<1），第 48 周的深度缓解和无激素临床缓解。
在筛选的 113 名患者中，有 73 名被随机分配，其中 66 名（35 名-FMT-AID；31 名-SMT）被纳入改良意向治疗分析（年龄 35.7±11.1 岁；男性 60.1%；疾病持续时间 48（IQR 24-84）个月；全结肠炎 34.8%；SCCAI 6（IQR 5-7）；UCEIS 4（IQR 3-5））。基线特征具有可比性。FMT-AID 诱导临床应答（23/35（65.7%）vs 11/31（35.5%），p=0.01，OR 3.5（95%CI 1.3-9.6））、缓解（21/35（60%）vs 10/31（32.3%），p=0.02，OR 3.2（95%CI 1.1-8.7））和深度缓解（12/33（36.4%）vs 2/23（8.7%），p=0.03，OR 6.0（95%CI 1.2-30.2））的效果优于 SMT，在第 8 周时。抗炎饮食在维持深度缓解方面优于 SMT，直到第 48 周（6/24（25%）vs 0/27，p=0.007）。
多供体 FMT 联合抗炎饮食可有效诱导轻度至中度 UC 患者的深度缓解，并在 1 年以上时间内通过抗炎饮食维持缓解。
ISRCTN82664502。
