1型糖尿病合并严重胃肠道神经病变患者的粪便微生物群移植（FADIGAS）：一项随机、双盲、安慰剂对照试验。
Faecal microbiota transplantation for patients with diabetes type 1 and severe gastrointestinal neuropathy (FADIGAS): a randomised, double-blinded, placebo-controlled trial.
作者信息
Høyer Katrine Lundby, Dahl Baunwall Simon Mark, Kornum Ditte Smed, Klinge Mette Winther, Drewes Asbjørn Mohr, Yderstræde Knud Bonnet, Thingholm Louise Bruun, Mortensen Martin Steen, Mikkelsen Susan, Erikstrup Christian, Hvas Christian Lodberg, Krogh Klaus
机构信息
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.
出版信息
EClinicalMedicine. 2024 Dec 16;79:103000. doi: 10.1016/j.eclinm.2024.103000. eCollection 2025 Jan.
BACKGROUND
Diabetic gastroenteropathy is associated with nausea, vomiting, bloating, pain, constipation, and diarrhoea. Current therapies are scarce. We tested faecal microbiota transplantation (FMT) for patients with type 1 diabetes and gastroenteropathy.
METHODS
In a randomised, double-blinded, placebo-controlled pilot trial, adults with type 1 diabetes and moderate-to-severe gastrointestinal symptoms were randomised (1:1) to encapsulated FMT or placebo. Each patient received around 25 capsules containing 50 g of faeces, administered in a single dose. The placebo capsules contained glycerol, saline and food colouring. All patients received FMT as a second intervention. The primary endpoint was number of adverse events of severity grade 2 or more assessed by the Common Terminology Criteria for Adverse Events during the week following the first intervention. Secondary endpoints included gastrointestinal symptoms and quality of life assessed four weeks after treatment. Public trial registration, ClinicalTrials.govNCT04749030.
FINDINGS
We randomised 20 patients to FMT or placebo. Following this intervention, 26 adverse events of grade 2 or more occurred. Four patients in the FMT group reported seven adverse events, and five patients in the placebo group reported 19, with no differences between the groups. The most frequent adverse events were diarrhoea, bloating, and abdominal pain. No serious adverse events were related to the treatment. Patients who received FMT reduced their median Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome score from 58 (IQR 54-65) to 35 (32-48), whereas patients receiving placebo reduced their score from 64 (55-70) to 56 (50-77) (p = 0.01). The Irritable Bowel Syndrome Impact Scale score improved from 108 (101-123) to 140 (124-161) with FMT and 77 (53-129) to 92 (54-142) with placebo (p = 0.02). The Patient Assessment of Gastrointestinal Symptom Severity Index declined from a median of 42 (28-47) to 25 (14-31) after FMT and 47 (31-69) to 41 (36-64) after placebo (p = 0.03).
INTERPRETATION
FMT was safe and improved clinical outcomes for patients with type 1 diabetes suffering from bowel symptoms.
FUNDING
Steno Collaborative Grant.
背景
糖尿病性胃肠病与恶心、呕吐、腹胀、疼痛、便秘和腹泻有关。目前的治疗方法很少。我们对1型糖尿病合并胃肠病患者进行了粪便微生物群移植（FMT）测试。
方法
在一项随机、双盲、安慰剂对照的试点试验中，患有1型糖尿病和中度至重度胃肠道症状的成年人被随机（1:1）分为接受胶囊装FMT或安慰剂组。每位患者接受约25粒含有50克粪便的胶囊，单次给药。安慰剂胶囊含有甘油、生理盐水和食用色素。所有患者均接受FMT作为第二次干预。主要终点是首次干预后一周内根据不良事件通用术语标准评估的2级或更高级别不良事件的数量。次要终点包括治疗四周后评估的胃肠道症状和生活质量。公开试验注册，ClinicalTrials.govNCT04749030。
研究结果
我们将20名患者随机分为FMT组或安慰剂组。此次干预后，发生了26起2级或更高级别的不良事件。FMT组的4名患者报告了7起不良事件，安慰剂组的5名患者报告了19起，两组之间无差异。最常见的不良事件是腹泻、腹胀和腹痛。没有严重不良事件与治疗相关。接受FMT的患者的胃肠道症状评分量表-肠易激综合征中位数评分从58（四分位间距54-65）降至35（32-48），而接受安慰剂的患者的评分从64（55-70）降至56（50-77）（p=0.01）。FMT组的肠易激综合征影响量表评分从108（101-123）提高到140（124-161），安慰剂组从77（53-129）提高到92（54-142）（p=0.02）。FMT后患者胃肠道症状严重程度指数中位数从42（28-47）降至25（14-31），安慰剂后从47（31-69）降至41（36-64）（p=0.03）。
解读
FMT对患有肠道症状的1型糖尿病患者是安全的，并改善了临床结局。
资助
斯滕诺合作基金。
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