{"title":"Randomized Placebo-Controlled Trial of Psyllium Fiber in Functional Abdominal Pain Disorders in Children.","authors":"Manjit Kaur, Ujjal Poddar, Anshu Srivastava, Moinak Sen Sarma, Prabhakar Mishra","doi":"10.1007/s10620-026-10156-9","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Functional abdominal pain disorders (FAPD) are common in children and there is heterogeneity in the available literature regarding the role of fibre in FAPD and none so-far in functional abdominal pain-not otherwise specified (FAP-NOS).</p><p><strong>Aim: </strong>The study aimed to evaluate the efficacy of psyllium fiber in pediatric FAPD including Irritable bowel syndrome (IBS) and FAP-NOS.</p><p><strong>Methods: </strong>In this prospective randomized placebo-controlled trial, children (5-18 years) diagnosed as FAPD based on Rome IV criteria were randomized to psyllium fiber or placebo (maltodextrin) for 12 weeks. Post-treatment improvement of pain and quality of life (QoL) from baseline was compared between the two groups. Pain assessment was done using the pain score table, which assessed duration, frequency, and intensity of pain.</p><p><strong>Results: </strong>The mean age of 109 children (FAP-NOS: 85%; psyllium fiber 57, placebo 52) was 11.8 ± 3.9 years (58% boys). There was a significant difference in pain improvement in terms of reduction in scores for intensity (5.5 vs. 3.2), frequency (6.0 vs. 3.2), duration (5.3 vs. 3.3), and QoL (4.4 vs. 2.3) between the psyllium and placebo group (P < 0.001 in all). Responders (> 50% reduction in pain) were seen in 86% of the psyllium as compared to 60% in the placebo group (P = 0.001). On multivariate analysis, use of psyllium fiber was the only factor predictive of response (OR: 5.49, 95% CI 2.05-14.72, P < 0.001). After discontinuation of psyllium fiber, 81% had sustained response over a mean follow-up of 6.7 ± 4.0 months.</p><p><strong>Conclusions: </strong>A 12-week trial of psyllium fiber improves pain in most and gives sustained relief in three-fourths of children with FAP-NOS and IBS.</p><p><strong>Clinical trial registration: </strong>Clinical Trial Registry of India ( CTRI/2023/08/056772; Website http://ctri.nic.in ).</p>","PeriodicalId":11378,"journal":{"name":"Digestive Diseases and Sciences","volume":" ","pages":"5801-5811"},"PeriodicalIF":2.8000,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Digestive Diseases and Sciences","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10620-026-10156-9","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/8/4 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Functional abdominal pain disorders (FAPD) are common in children and there is heterogeneity in the available literature regarding the role of fibre in FAPD and none so-far in functional abdominal pain-not otherwise specified (FAP-NOS).
Aim: The study aimed to evaluate the efficacy of psyllium fiber in pediatric FAPD including Irritable bowel syndrome (IBS) and FAP-NOS.
Methods: In this prospective randomized placebo-controlled trial, children (5-18 years) diagnosed as FAPD based on Rome IV criteria were randomized to psyllium fiber or placebo (maltodextrin) for 12 weeks. Post-treatment improvement of pain and quality of life (QoL) from baseline was compared between the two groups. Pain assessment was done using the pain score table, which assessed duration, frequency, and intensity of pain.
Results: The mean age of 109 children (FAP-NOS: 85%; psyllium fiber 57, placebo 52) was 11.8 ± 3.9 years (58% boys). There was a significant difference in pain improvement in terms of reduction in scores for intensity (5.5 vs. 3.2), frequency (6.0 vs. 3.2), duration (5.3 vs. 3.3), and QoL (4.4 vs. 2.3) between the psyllium and placebo group (P < 0.001 in all). Responders (> 50% reduction in pain) were seen in 86% of the psyllium as compared to 60% in the placebo group (P = 0.001). On multivariate analysis, use of psyllium fiber was the only factor predictive of response (OR: 5.49, 95% CI 2.05-14.72, P < 0.001). After discontinuation of psyllium fiber, 81% had sustained response over a mean follow-up of 6.7 ± 4.0 months.
Conclusions: A 12-week trial of psyllium fiber improves pain in most and gives sustained relief in three-fourths of children with FAP-NOS and IBS.
Clinical trial registration: Clinical Trial Registry of India ( CTRI/2023/08/056772; Website http://ctri.nic.in ).
背景：功能性腹痛障碍（FAPD）在儿童中很常见，现有文献中关于纤维在FAPD中的作用存在异质性，迄今尚无关于功能性腹痛（FAP-NOS）的文献。目的：评价车前草纤维治疗小儿肠易激综合征（IBS）和FAP-NOS的疗效。方法：在这项前瞻性随机安慰剂对照试验中，根据Rome IV标准诊断为FAPD的儿童（5-18岁）随机接受车前草纤维或安慰剂（麦芽糖糊精）治疗12周。比较两组治疗后疼痛和生活质量（QoL）的改善情况。疼痛评估采用疼痛计分表，评估疼痛持续时间、频率和强度。结果：109例儿童（FAP-NOS: 85%；车前子纤维57例，安慰剂52例）的平均年龄为11.8±3.9岁（58%为男孩）。在强度（5.5 vs. 3.2）、频率（6.0 vs. 3.2）、持续时间（5.3 vs. 3.3）和生活质量（4.4 vs. 2.3）评分方面，车前子组和安慰剂组在疼痛改善方面存在显著差异（P < 0.05）， 86%的车前子组疼痛减轻50%，而安慰剂组为60% （P = 0.001）。在多因素分析中，使用车前草纤维是预测疗效的唯一因素（OR: 5.49, 95% CI 2.05-14.72， P）。结论：为期12周的车前草纤维试验改善了大多数FAP-NOS和IBS患儿的疼痛，并使四分之三的FAP-NOS和IBS患儿的疼痛得到持续缓解。临床试验注册：印度临床试验注册中心（CTRI/2023/08/056772；网站http://ctri.nic.in）。
期刊介绍：
Digestive Diseases and Sciences publishes high-quality, peer-reviewed, original papers addressing aspects of basic/translational and clinical research in gastroenterology, hepatology, and related fields. This well-illustrated journal features comprehensive coverage of basic pathophysiology, new technological advances, and clinical breakthroughs; insights from prominent academicians and practitioners concerning new scientific developments and practical medical issues; and discussions focusing on the latest changes in local and worldwide social, economic, and governmental policies that affect the delivery of care within the disciplines of gastroenterology and hepatology.
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