Low-FODMAP vs Lactose-Gluten-Free Diet in Patients With Irritable Bowel Syndrome
2026年7月21日 更新者：Antalya Bilim University
Comparative Effects of Low-FODMAP and Lactose-Gluten-Free Diets on Gastrointestinal Symptoms and Mental Health in Irritable Bowel Syndrome: A Randomized Crossover Trial
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder that substantially affects quality of life.
Dietary therapy is considered one of the primary treatment approaches; however, the optimal sequence of dietary interventions remains unclear.
This randomized crossover trial was designed to compare the effects of a low-FODMAP diet and a lactose-free, gluten-free diet on gastrointestinal symptoms, psychological status, anthropometric measurements, and biochemical parameters in adults with IBS.
Participants were randomly assigned to one of two dietary sequences, with each intervention lasting four weeks and separated by a one-week washout period.
Outcomes were assessed using validated symptom and psychological questionnaires together with anthropometric and biochemical measurements before and after each intervention period.
研究概览
详细说明
This randomized crossover trial was designed to evaluate the comparative effects of a low-FODMAP diet and a lactose- and gluten-free diet in adults with irritable bowel syndrome (IBS).
Participants were randomly assigned to one of two dietary sequences, with each intervention lasting 4 weeks and separated by a 1-week washout period.
Gastrointestinal symptoms, psychological outcomes, anthropometric measurements, and biochemical parameters were assessed before and after each intervention period.
研究类型
介入性
注册 (实际的)
72
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Istanbul、土耳其（türkiye）
- Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Gastroenterology
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Adults aged 18-64 years.
- Diagnosis of Irritable Bowel Syndrome according to the Rome III criteria.
- Ability and willingness to comply with the dietary intervention.
- Written informed consent provided.
Exclusion Criteria:
- Pregnancy or lactation.
- Diabetes mellitus.
- Organic gastrointestinal disease.
- Current follow-up for cardiologic, neurologic, oncologic, or psychiatric disorders.
- Following a therapeutic diet within 1 month before enrollment.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Low-FODMAP → Lactose- and Gluten-Free Diet
Participants received the low-FODMAP diet for 4 weeks, followed by a 1-week washout period and then the lactose- and gluten-free diet for 4 weeks.
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Participants followed a low-FODMAP diet for 4 weeks under the supervision of a dietitian.
Participants followed a lactose- and gluten-free diet for 4 weeks under the supervision of a dietitian.
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实验性的：Lactose- and Gluten-Free Diet → Low-FODMAP
Participants received the lactose- and gluten-free diet for 4 weeks, followed by a 1-week washout period and then the low-FODMAP diet for 4 weeks.
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Participants followed a low-FODMAP diet for 4 weeks under the supervision of a dietitian.
Participants followed a lactose- and gluten-free diet for 4 weeks under the supervision of a dietitian.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
大体时间：Baseline, Week 4, and Week 9
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Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS).
The IBS Symptom Severity Score assessed the severity of IBS symptoms based on four questions, scoring between 0 and 100 points for each symptom.
A total score of 75-174 points indicated mild IBS, 175-299 points indicated moderate IBS, and >300 points indicated severe IBS.
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Baseline, Week 4, and Week 9
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change in Gastrointestinal Symptom Rating Scale (GSRS) score
大体时间：Baseline, Week 4, and Week 9
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Change in gastrointestinal symptom severity assessed using the Gastrointestinal Symptom Rating Scale (GSRS).
The GSRS assessed gastrointestinal symptoms based on 15 items categorized into five subdimensions: abdominal pain, reflux, diarrhea, indigestion, and constipation.
The scale measures symptom severity over the past week, with higher scores indicating more severe symptoms.
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Baseline, Week 4, and Week 9
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Change in Hospital Anxiety and Depression Scale (HADS) score
大体时间：Baseline, Week 4, and Week 9
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Change in anxiety and depression symptoms assessed using the Hospital Anxiety and Depression Scale (HADS).
The HADS is a 14-question scale that identifies anxiety and depression risks.
The scale is divided into two subscales, one for anxiety and one for depression, with scores ranging from 0 to 21. Scores between 0-7 are considered normal, 8-10 borderline, and ≥11 indicates anxiety and/or depression.
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Baseline, Week 4, and Week 9
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Change in body weight
大体时间：Baseline, Week 4, and Week 9
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Change in body weight measured in kilograms.
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Baseline, Week 4, and Week 9
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Change in body mass index
大体时间：Baseline, Week 4, and Week 9
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Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared.
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Baseline, Week 4, and Week 9
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Hatice Kübra Aras、Antalya Bilim University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年9月1日
初级完成 (实际的)
2021年11月25日
研究完成 (实际的)
2022年1月20日
研究注册日期
首次提交
2026年7月16日
首先提交符合 QC 标准的
2026年7月21日
首次发布 (实际的)
2026年7月23日
研究记录更新
最后更新发布 (实际的)
2026年7月23日
上次提交的符合 QC 标准的更新
2026年7月21日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2020/034
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.