Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Positive and Negative Affect Schedule
研究概览
简要总结
The investigators will investigate the effects of acute and sub-acute administration of gluten on mood, intestinal permeability, gastrointestinal symptoms, gut microbiota and cortisol levels in NCGS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-coeliac gluten sensitivity patients
- •Previous symptoms of IBS fulfilling Rome III criteria that self reportedly improved with a gluten-free diet
- •Symptoms currently well controlled on a gluten-free diet
- •Adherence to the gluten-free diet for at least 6 weeks prior to recruitment
- •Coeliac disease excluded (either by absence of the HLA-DQ2 and HLA-DQ8 haplotype or by a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten-containing diet in individuals expressing the HLA-DQ2 or HLA-DQ8 haplotype)
- •IgA anti-tissue-transglutaminase or IgG anti-deaminated gliadin peptide positive
- •Body Mass Index (BMI) of 20 - 25 kg/m2
- •Stable body weight for at least 3 months prior to the start of the study
排除标准
- •Coeliac disease
- •Abdominal or thoracic surgery. Exception: appendectomy
- •Gastrointestinal, endocrine or neurological diseases
- •Cardiovascular, respiratory, renal or urinary diseases
- •Hypertension
- •Food or drug allergies
- •Psychiatric disorders
- •Eating disorders
- •Depressive disorders
- •Anxiety disorders
- •Psychotic disorders
- •Restraint or emotional eating
- •Medication on a regular basis, exception: oral contraception
- •History of cannabis use or any other drug of abuse for at least 12 months prior to the study
- •Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
- •Pregnant or breastfeeding women
研究组 & 干预措施
Gluten
Patients will receive acutely 16 g of gluten and 2 muffins glutenfree with 8 g of gluten, twice a day, during 5 days
干预措施: Gluten (Other)
Placebo
Patients will receive acutely 16 g of whey protein and 2 glutenfree muffins, twice a day, during 5 days
干预措施: Placebo (Other)
结局指标
主要结局
The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Positive and Negative Affect Schedule
时间窗: At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40)
Change from baseline. Scores can be 'very slightly or not at all', 'a little', 'moderately', 'quite a bit', 'extremely'
The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Profile of Mood State
时间窗: At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40)
Scores are measured on the Visual Analogue Scale. Change from baseline. The scale is ranged 0 - 10, in which 0 no occurrence of the symptom and 10 a lot occurrence of the symptom. Measured at day 0, day 15, day 21, day 36 and day 41.
次要结局
- The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in NCGS patients measured on the visual analogue scale for gastrointestinal symptoms(At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40))
- Effect of acute and sub-acute gluten administration on intestinal permeability (lactulose mannitol ratio)(At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 21), after test visit 3 (at day 36), after test visit 4 (at day 41))
- Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in bloodsample(During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41))
- Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in bloodsample(During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41))
- Effect of acute and sub-acute gluten administration on lipopolysaccharide levels in bloodsample(During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41))
- Effect of acute and sub-acute gluten administration on gut microbiota composition(After test visit 0 (day 0), day 13 and day 14, after test visit 1 (day 15), day 16, 17, 18, 19 and 20, two days before test visit 3 (day 34 and 35), day 36, 37, 38, 39, 40)
- Effect of acute and sub-acute gluten administration on cortisol awakening response(Day before test visit 1 (day 14), test visit 1 (day 15), test visit 2 (day 21), day before test visit 3 (day 35), test visit 3 (day 36) and test visit 4 (day 41))
研究者
Prof Dr Jan Tack
Principal Investigator
Universitaire Ziekenhuizen KU Leuven