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一项随机对照试验的方案,以确定生物标志物是否能预测对儿科慢性疼痛症状管理计划的反应。

Protocol for a Randomized Controlled Trial to Determine if Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program.

作者信息

Levy Rona L, Murphy Tasha B, Heitkemper Margaret M, van Tilburg Miranda A L, McMeans Ann R, Chang Jocelyn, Boutte Cynthia, Lamparyk Katherine, Chumpitazi Bruno P, Shulman Robert J

机构信息

School of Social Work, University of Washington, Seattle, WA 98195, USA.

School of Nursing, University of Washington, Seattle, WA 98195, USA.

出版信息

J Clin Med. 2025 May 5;14(9):3185. doi: 10.3390/jcm14093185.


DOI:10.3390/jcm14093185
PMID:40364216
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12072368/
Abstract

: Disorders of gut-brain interaction (DGBI), characterized by chronic abdominal pain and significant disability, affect 15-20% of children and adults and continue into adulthood in ~60% of cases. Costs for adults reach USD 30 billion per year, yet effective management strategies are elusive. Studies support using cognitive behavioral therapy (CBT), but abdominal pain only improves in ~40% of patients. Dietary management (low FODMAP diet; LFD) has also shown promise but it is effective in only a similar percentage of patients. Studies suggest that biologic factors (biomarkers) contribute to CBT response. Similarly, gut microbiome composition appears to influence abdominal pain response to the LFD. However, no previous CBT trials in children or adults have measured these biomarkers, and it is unclear which patients respond best to CBT vs. LFD. : Children aged 7-12 years with DGBIs ( = 200) will be categorized as having/not having Autonomic Nervous System imbalance and/or abnormalities in gut physiology. We will randomize these children to either CBT or a LFD to compare the effectiveness of these treatments in those with/without abnormal physiologic biomarkers. We hypothesize that CBT will be more effective in those without abnormal physiology and LFD will be more effective in children with abnormal physiology. Primary outcome measures include the following: (1) Symptom improvement (abdominal pain frequency/severity) and (2) improvement in health-related quality of life. : This innovative multidisciplinary study is the first to identify physiological characteristics that may moderate the response to two different management strategies. Identification of these characteristics may reduce the burden of these disorders through timely application of the intervention most likely to benefit an individual patient.

摘要

肠脑互动障碍(DGBI)以慢性腹痛和严重功能障碍为特征,影响15%至20%的儿童和成人,约60%的病例会持续到成年期。成人每年的费用高达300亿美元,但有效的管理策略却难以捉摸。研究支持使用认知行为疗法(CBT),但只有约40%的患者腹痛症状得到改善。饮食管理(低FODMAP饮食;LFD)也显示出前景,但仅在类似比例的患者中有效。研究表明,生物学因素(生物标志物)有助于CBT治疗反应。同样,肠道微生物群组成似乎会影响腹痛对LFD的反应。然而,之前在儿童或成人中进行的CBT试验均未测量这些生物标志物,尚不清楚哪些患者对CBT与LFD反应最佳。 7至12岁患有DGBI的儿童(n = 200)将被分类为是否存在自主神经系统失衡和/或肠道生理异常。我们将把这些儿童随机分为CBT组或LFD组,以比较这些治疗方法对生理生物标志物正常/异常的患者的有效性。我们假设CBT对生理正常的患者更有效,而LFD对生理异常的儿童更有效。主要结局指标包括:(1)症状改善(腹痛频率/严重程度)和(2)健康相关生活质量的改善。 这项创新的多学科研究首次确定了可能调节对两种不同管理策略反应的生理特征。识别这些特征可能通过及时应用最有可能使个体患者受益的干预措施来减轻这些疾病的负担。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/329c/12072368/ef6dedd11afa/jcm-14-03185-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/329c/12072368/ef6dedd11afa/jcm-14-03185-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/329c/12072368/ef6dedd11afa/jcm-14-03185-g001.jpg

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本文引用的文献

[1]
Effect of the Low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet on Control of Pediatric Irritable Bowel Syndrome and Quality of Life Among a Sample of Egyptian Children: A Randomized Controlled Clinical Trial.

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[2]
Evolution, adaptation, and new applications of the FODMAP diet.

JGH Open. 2024-5-20

[3]
Heart Rate Variability and Somatization in Adolescents With Irritable Bowel Syndrome.

J Neurogastroenterol Motil. 2023-4-30

[4]
Heart Rate Variability-An Index of the Efficacy of Complementary Therapies in Irritable Bowel Syndrome: A Systematic Review.

Nutrients. 2022-8-22

[5]
How to Implement the 3-Phase FODMAP Diet Into Gastroenterological Practice.

J Neurogastroenterol Motil. 2022-7-30

[6]
Children with functional abdominal pain disorders successfully decrease FODMAP food intake on a low FODMAP diet with modest improvements in nutritional intake and diet quality.

Neurogastroenterol Motil. 2022-10

[7]
Cognitive behavioral therapy for irritable bowel syndrome induces bidirectional alterations in the brain-gut-microbiome axis associated with gastrointestinal symptom improvement.

Microbiome. 2021-11-30

[8]
Management of functional gastrointestinal disorders.

Clin Med (Lond). 2021-1

[9]
A Comprehensive Self-Management Program With Diet Education Does Not Alter Microbiome Characteristics in Women With Irritable Bowel Syndrome.

Biol Res Nurs. 2021-7

[10]
Fructan-sensitive children with irritable bowel syndrome have distinct gut microbiome signatures.

Aliment Pharmacol Ther. 2021-2

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