The Effects of Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAPs) in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) (7-10 days recall questionnaire)
研究概览
简要总结
Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in dietary management recently increased, including the use of a low FODMAP diet.
To investigate relation of FODMAPs and IBS, a randomized, double-blind, cross-over trial will be carried out in adult (>18) patients with IBS according to Rome IV criteria. The aim is to assess low FODMAP diet versus moderate/high FODMAP diet in IBS patients.
详细描述
The study is a randomized, double-blind, cross-over trial.
The aim is to assess the effects of low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet compared to moderate/high FODMAP diet in IBS patients on gastrointestinal symptoms and psychological factors. The primary hypothesis is that the low FODMAP diet decreases gastrointestinal symptoms compared to moderate/high FODMAP diet, and that this change is accompanied with reduced psychological distress.
IBS patients (Rome IV) are challenged with FODMAPs in this randomized, double-blinded, cross-over study. The subjects will start with the low FODMAP diet or moderate/high FODMAP diet and cross over to the other intervention (both for 7 days). In between the interventions, there is a wash-out period of at least 14 days. The subjects will receive ready-made meals from the hospital kitchen (lunch and dinner) and in between snacks. The subjects are instructed to buy breakfast themselves and the subjects will receive information on which other foods to avoid, without mentioning 'FODMAPs'. The subjects will follow their usual diet (as before initiation of the study) during the wash-out period.
Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires, including IBS Severity Scoring System (IBS-SSS) (7-10 day recall and modified daily) and Gastrointestinal Symptom Rating Scale -IBS (GSRS-IBS). A 50-point reduction in IBS-SSS indicates clinical response. Bacterial fermentation (exhaled hydrogen and methane) and visceral sensitivity will be measured using the Lactulose Nutrient Challenge Test. Secondary outcomes are change in psychological factors and assessed by questionnaires, including Central Sensitization Index (CSI), Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire (PHQ)-15 and Visceral Sensitivity Index (VSI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
The randomization was done by employees of the hospital that were otherwise not involved in the study by drawing concealed envelops. The interventions were meal boxes which looked similar.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with IBS according to Rome IV criteria
排除标准
- •allergy or documented intolerance to food
- •severe cardiovascular disease
- •severe hepatic disease
- •severe neurological disease
- •severe psychiatric disease
- •celiac disease
- •inflammatory bowel diseases
- •bowel dysfunction related to previous surgery
- •pregnant or lactating women
- •use of antibiotics within four weeks before inclusion
- •strict avoidance of foods
结局指标
主要结局
Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) (7-10 days recall questionnaire)
时间窗: Baseline (day 0), day 7, day 21, day 28
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) is a validated questionnaire that incorporates typical IBS symptoms such as abdominal pain, abdominal distension and bowel dysfunction, as well as quality of life. Subjects rated their symptoms on a visual analogue scale. The maximum achievable score is 500 points (sum of the 5 scales). A reduction in the total IBS-SSS score of at least 50 points is considered to indicate a clinically significant improvement in symptoms. The scale can also be used to classify IBS symptoms severity: \<75 points (no symptoms), 75-175 points (mild symptoms), 175-300 points (moderate symptoms) and \>300 points (severe symptoms). Measured after both dietary periods and at baseline of both periods.
Change in Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)
时间窗: Baseline (day 0), day 7, day 21, day 28
Change in Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS) measures symptom severity and symptom frequency in IBS patients and is a reliable and validated questionnaire. Thirteen questions are evaluated and rated from 1 (no discomfort at all) to 7 (very severe discomfort) on a Likert scale. The total scores can range from 13 to 91 (sum of the domains). The GSRS-IBS evaluates 5 domains: abdominal pain, bloating, constipation, diarrhea and satiety. Measured after both dietary periods and at baseline of both periods.
Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) (modified, daily IBS-SSS)
时间窗: Daily during day 7 to 14, and day 21 to 28
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) is a validated questionnaire that incorporates typical IBS symptoms such as abdominal pain, abdominal distension and bowel dysfunction, as well as quality of life. Subjects rated their symptoms on a visual analogue scale. The maximum achievable score is 500 points (sum of the 5 scales). A reduction in the total IBS-SSS score of at least 50 points is considered to indicate a clinically significant improvement in symptoms. The scale can also be used to classify IBS symptoms severity: \<75 points (no symptoms), 75-175 points (mild symptoms), 175-300 points (moderate symptoms) and \>300 points (severe symptoms). Measured after both dietary periods and at baseline of both periods.
次要结局
- Change in Patient health questionnaire-15 (PHQ-15)(Baseline (day 0), day 7, day 21, day 28)
- Change in stool consistency and frequency, measured by Bristol Stool Form (BSF)(Baseline (day 0), day 7, day 21, day 28)
- Change in Hospital Anxiety and Depression Scale (HADS) score(Baseline (day 0), day 7, day 21, day 28)
- Change in Visceral Sensitivity Index (VSI)(Baseline (day 0), day 7, day 21, day 28)
研究者
Magnus Simrén
Professor
Sahlgrenska University Hospital