Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital RWTH Aachen, Aachen, Germany.
Institute of Medical Informatics and Statistics, Kiel University, Kiel, Germany.
Trials. 2022 Jul 5;23(1):545. doi: 10.1186/s13063-022-06413-7.
Anorexia nervosa (AN) is a severe psychiatric disease that often takes a chronic course due to insufficient treatment options. Emerging evidence on the gut-brain axis offers the opportunity to find innovative treatments for patients with psychiatric disorders. The gut microbiome of patients with AN shows profound alterations that do not completely disappear after weight rehabilitation. In previous studies, the administration of polyunsaturated fatty acids (PUFA) resulted in effects that might be beneficial in the treatment of AN, affecting the microbiome, body weight and executive functions. Therefore, the MiGBAN study aims to examine the effects of a nutritional supplementation with PUFA on the gut microbiome and body mass index (BMI) in patients with AN.
This is a longitudinal, double-blind, randomized, placebo-controlled trial. Within 2 years, 60 adolescent patients aged 12 to 19 years with AN will receive either PUFA or placebo for 6 months additional to treatment as usual. After 1 year, the long-term effect of PUFA on the gut microbiome and consecutively on BMI will be determined. Secondary outcomes include improvement of gastrointestinal symptoms, eating disorder psychopathology, and comorbidities. Additionally, the interaction of the gut microbiome with the brain (microbiome-gut-brain axis) will be studied by conducting MRI measurements to assess functional and morphological changes and neuropsychological assessments to describe cognitive functioning. Anti-inflammatory effects of PUFA in AN will be examined via serum inflammation and gut permeability markers. Our hypothesis is that PUFA administration will have positive effects on the gut microbiota and thus the treatment of AN by leading to a faster weight gain and a reduction of gastrointestinal problems and eating disorder psychopathology.
Due to previously heterogeneous results, a systematic and longitudinal investigation of the microbiome-gut-brain axis in AN is essential. The current trial aims to further analyse this promising research field to identify new, effective therapeutic tools that could help improve the treatment and quality of life of patients. If this trial is successful and PUFA supplementation contributes to beneficial microbiome changes and a better treatment outcome, their administration would be a readily applicable additional component of multimodal AN treatment.
German Clinical Trials Register DRKS00017130 . Registered on 12 November 2019.
神经性厌食症（AN）是一种严重的精神疾病，由于治疗选择有限，往往呈慢性病程。肠道-大脑轴的新出现的证据为精神障碍患者提供了寻找创新治疗方法的机会。神经性厌食症患者的肠道微生物组显示出深刻的改变，这些改变在体重恢复后并未完全消失。在以前的研究中，多不饱和脂肪酸（PUFA）的给药导致了可能有益于治疗 AN 的影响，影响了微生物组、体重和执行功能。因此，MiGBAN 研究旨在检查 PUFA 营养补充对 AN 患者肠道微生物组和体重指数（BMI）的影响。
这是一项纵向、双盲、随机、安慰剂对照试验。在 2 年内，60 名年龄在 12 至 19 岁的患有 AN 的青少年患者将在接受常规治疗的基础上额外接受 6 个月的 PUFA 或安慰剂治疗。1 年后，将确定 PUFA 对肠道微生物组的长期影响，随后对 BMI 进行确定。次要结局包括胃肠道症状、饮食障碍心理病理学和合并症的改善。此外，通过进行 MRI 测量来评估功能和形态变化以及神经心理学评估来描述认知功能，研究肠道微生物组与大脑的相互作用（微生物组-肠道-大脑轴）。通过血清炎症和肠道通透性标志物检查 AN 中 PUFA 的抗炎作用。我们的假设是，PUFA 的给药将对肠道微生物群产生积极影响，从而通过更快地增加体重和减少胃肠道问题和饮食障碍心理病理学来治疗 AN。
由于之前的结果存在异质性，对 AN 中的微生物组-肠道-大脑轴进行系统和纵向研究至关重要。目前的试验旨在进一步分析这个有前途的研究领域，以确定新的、有效的治疗工具，这可能有助于改善患者的治疗和生活质量。如果这项试验成功，并且 PUFA 补充有助于有益的微生物组变化和更好的治疗结果，那么它们的给药将成为多模式 AN 治疗的一个易于应用的附加组成部分。
德国临床试验注册处 DRKS00017130。注册于 2019 年 11 月 12 日。
