The Effect of Gluten in Patients With Irritable Bowel Syndrome and Healthy Volunteers: a Randomized, Placebo-controlled Double-blind Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS)
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 gluten-free diet.
To investigate relation of gluten-free diet (GFD) and IBS, a randomized, double-blind, placebo-controlled cross-over trial will be carried out in adults (>18) and patients with IBS according to Rome IV criteria. The aim is to assess gluten-free versus gluten-containing diet in IBS patients and Healthy Volunteers.
详细描述
The study is a randomized, double-blind, placebo-controlled, cross-over trial.
The aim is to assess the effects of gluten-free diet (GFD) compared to gluten-containing diet (GCD) in IBS patients and Healthy Volunteers on gastrointestinal symptoms, visceral sensitivity, bacterial fermentation, psychological factors and quality of life. The primary hypothesis is that GFD decreases gastrointestinal symptoms compared to GCD and that this change is accompanied with reduced visceral sensitivity and change in bacterial fermentation. The secondary hypothesis is that GFD positively influences psychological factors and quality of life.
IBS patients (Rome IV) and Healthy Volunteers are challenged with gluten in this randomized, double-blind, placebo-controlled, cross-over study. They start with GFD or GCD and cross over to the other intervention (both for 14 days). In between there is a wash-out period of at least 14 days. The subjects will get gluten-free meals (lunch and dinner) and have to sprinkle powder over the meals, concealed in sachets with either gluten (vital gluten) or placebo (rice starch). The subjects will follow a strict GFD during the GFD and GCD periods. The subjects will eat and drink as before the study during the washout period.
Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires, including IBS Severity Scoring System (IBS-SSS) and Gastrointestinal Symtom 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 quality of life assessed by questionnaires, including CSI, HADS, HSPS, IBSQOL, PHQ-15 and 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 concealed plastic bags marked A or B.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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, hepatic, neurological or psychiatric disease
- •serious gastrointestinal disease: including celiac disease and inflammatory bowel diseases (IBD),
- •bowel dysfunction related to previous surgery
- •pregnant or lactating women
- •usage of antibiotics within 4 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)
时间窗: Baseline(day 0), day 14, day 28, day 42
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 14, day 28, day 42
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 stool frequency, measured by Bristol Stool Form (BSF)
时间窗: Day 14, Day 42
Change in Bristol Stool Form, stool frequency per day after both dietary periods
Change in Visceral Sensitivity and Bacterial Fermentation
时间窗: Baseline(day 0), day 14, day 28, day 42
Visceral Sensitivity and Bacterial Fermentation measured by the Lactulose-Nutrient Challenge Test.
次要结局
- Change in Hospital Anxiety and Depression Scale (HADS) score(Baseline(day 0), day 14, day 28, day 42)
- Change in Irritable Bowel Syndrome Quality of Life Questionnaire (IBSQOL)(Baseline(day 0), day 14, day 28, day 42)
- Change in Visceral Sensitivity Index (VSI)(Baseline(day 0), day 14, day 28, day 42)
- Change in metabolic profile of frozen urine samples(Baseline(day 0), day 14, day 28, day 42)
- Change in microbiota content of frozen fecal samples(Baseline(day 0), day 14, day 28, day 42)
- Change in Patient health questionnaire-15 (PHQ-15)(Baseline(day 0), day 14, day 28, day 42)
- Change in Central Sensitization Inventory (CSI) score(Baseline(day 0), day 14, day 28, day 42)
- Change in Highly Sensitive Person Scale (HSPS)(Baseline(day 0), day 14, day 28, day 42)
- Change in immunological profile of frozen serum samples(Baseline(day 0), day 14, day 28, day 42)
研究者
Magnus Simrén
MD, PhD, Professor, Senior Consultant
Sahlgrenska University Hospital