Effects of β-glucan Based Dietary Fibres on Indomethacin-induced Hyperpermeability and Gut Microbiota Composition in Elderly: A Randomized Placebo-controlled Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Intestinal permeability at baseline (after indomethacin)
研究概览
简要总结
The investigators aim was to compare healthy young adults, senior orienteers (model of healthy ageing) and elderly with gastrointestinal symptoms on intestinal permeability, microbiota compositions and well-being. In addition, assess whether 3 weeks of oral intake of soluble or dispersible forms yeast-dervied beta-glucan could improve intestinal barrier function against drug-induced barrier disruption vs placebo for a cohort of elderly people with gastrointestinal symptoms, in a randomized double blinded placebo-controlled cross-over clinical trial.
详细描述
Baseline samples for measurements of intestinal permeability (multisugar test), microbiota composition (faecal samples) and well-being (questionnaires) were collected during the first week for:
Young healthy adults (healthy young controls) Senior orienteers (healthy elderly controls) Elderly with gastrointestinal (GI) symptoms
Thereafter only the elderly with GI symptoms continued into the randomized cross-over trial where they were blindly and randomly distributed one of the following: Soluble yeast-derived beta-glucan, dispersible (whole) yeast-derived beta-glucan and placebo. Each supplement was taken for 3 weeks with a 1 week washout until all participants had taken all supplements. Towards the end of each supplement period, samples for measurement of intestinal permeability and microbiota were collected, in addition to questionnaires being filled out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elderly with gastrointestinal symptoms
- •Inclusion Criteria:
- •Informed consent signed by study participant
- •Age >55 years
- •Scoring above 2 on the dimensions for diarrhoea and constipation on the Gastrointestinal symptoms rating scale (GSRS)
- •Mentally and physically fit to complete questionnaires during the study period
排除标准
- •Known or genic gastrointestinal diseasewith strictures, malignance's and ischemia.
- •Inflammatory bowel diseases (IBD)
- •Participation in other clinical trials in the past three months.
- •Intake of medications know to change the inflammatory status (i.e proton pump inhibitors, antibiotic, anti-inflammtory medication (including NSAIDs)
- •Healthy controls
- •Inclusion Criteria:
- •Age ≥ 18 years
- •Informed consent signed by the study participant
- •Mentally and physically fit to complete questionnaires during the study period
- •Exclusion Criteria:
- •Previous abdominal surgery
- •A hypertonic condition demanding medical treatment
- •Diagnosed psychiatric disease
- •Lactose intolerance
- •Usage of medical prescribed medications, expect oral contraceptives, during the 14 days preceding study start
- •Premenstrual syndrome
- •Pregnant or breast feeding
- •Known or genic gastrointestinal disease, with strictures, malignance's and ischemia.
- •Inflammatory bowel diseases (IBD)
- •Participation in other clinical trials in the past three months.
结局指标
主要结局
Intestinal permeability at baseline (after indomethacin)
时间窗: Day 1
In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
Changes in intestinal permeability 3 weeks after study supplementation 3 (before indomethacin)
时间窗: 3 weeks
Performed after study participants have orally taken study supplementation 3 for 3 weeks. In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
Changes in intestinal permeability 3 weeks after study supplementation 3 (after indomethacin)
时间窗: 3 weeks
Performed after study participants have orally taken study supplementation 3 for 3 weeks. In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
Changes in intestinal permeability 3 weeks after study supplementation 2 (after indomethacin)
时间窗: 3 weeks
Performed after study participants have orally taken study supplementation 2 for 3 weeks. In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
Changes in Intestinal permeability 3 weeks after study supplementation 1 (before indomethacin).
时间窗: 3 weeks
Performed after study participants have orally taken study supplementation 1 for 3 weeks. In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
Changes in intestinal permeability 3 weeks after study supplementation 1 (after indomethacin).
时间窗: 3 weeks
Performed after study participants have orally taken study supplementation 1 for 3 weeks. In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
Changes in intestinal permeability 3 weeks after study supplementation 2 (before indomethacin)
时间窗: 3 weeks
Performed after study participants have orally taken study supplementation 2 for 3 weeks. In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
Intestinal permeability at baseline (before indomethacin)
时间窗: Day 1
In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
次要结局
- Changes in bacterial species 3 weeks after study supplementation 1(3 weeks)
- Changes in bacterial species 3 weeks after study supplementation 2(3 weeks)
- Changes in microbiota diversity - Washout (1 week after ending supplementation 1, i.e. 4 weeks after baseline)(4 weeks)
- Changes in bacterial species - Washout (1 week after ending study supplementation 1, i.e. 4 weeks after baseline)(4 weeks)
- Changes in hospital and anxiety depression scores(up to 13 weeks)
- Changes in microbiota diversity 3 weeks after study supplementation 3(3 weeks)
- Changes in bacterial species 3 weeks after study supplementation 3(3 weeks)
- Changes in bacterial species - Washout (1 week after ending study supplementation 2, i.e. 4 weeks after baseline)(4 weeks)
- Changes in microbiota diversity 3 weeks after study supplementation 2(3 weeks)
- Microbiota diversity - at baseline(Day 1)
- Changes in microbiota diversity 3 weeks after study supplementation 1(3 weeks)
- Changes in microbiota diversity - Washout (1 week after ending study supplementation 2, i.e. 4 weeks after baseline)(4 weeks)
- Changes in microbiota diversity - Washout (1 week after ending study supplementation 3, i.e. 4 weeks after baseline)(4 weeks)
- Changes in bacterial species - Washout (1 week after ending study supplementation 3, i.e. 4 weeks after baseline)(4 weeks)
- Bacterial species - at baseline(Day 1)
- Changes in perceived stress scale scores(Up to 13 weeks)
- Changes in quality of life questionnaire scores(Up to 13 weeks)
- Changes in gastrointestinal symptom questionnaire scores(up to 13 weeks)
研究者
Robert Brummer
Professor, MD
Örebro University, Sweden