Biomarkers of Diet-microbiota Interactions in Irritable Bowel Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Metabolites in stool, urine and blood
研究概览
简要总结
Most patients suffering from the irritable bowel syndrome (IBS) report that ingestion of certain foods is a major trigger of symptoms, but the reason is unclear. Previous studies have shown that foods containing poorly absorbed carbohydrates (FODMAPs) are fermented by the bacteria in our bowels and these cause symptoms in some but not all patients. Gut bacteria are capable of producing various products, such as neuroimmune mediator histamine, that may be related to IBS symptoms. Our recent data suggest that consumption of FODMAPs promotes production of bacterial histamine.
The main objective of this study is to investigate bacterial production of histamine and its relationship to IBS symptoms. The study will involve 6 weeks on a low-FODMAP diet with three three-day interventions consisting of High- or Low-FODMAP drinks along with probiotics or placebo capsules. The patient's bacteria and metabolites will be analyzed at various time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults aged 18-75 with IBS (Rome IV criteria) who have self-reported previous improvement in their IBS symptoms while on a low FODMAP diet, or when excluding certain high-FODMAP foods, or patients in whom histamine is expected to play a key role (either diagnosed with high histamine producing bacteria, or improved IBS symptoms after using antihistamines). Individuals should be able to swallow size 00 capsules.
排除标准
- •Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.)
- •Concurrent systemic disease (such as diabetes) and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection
- •History of active cancer in the last 5 years, other than basal cell cancer
- •Pregnant or breastfeeding women
- •Active or recent participation (< 1 month) in a clinical study, except for SPOR IMAGINE
- •Use of antibiotics, probiotics, or ACE inhibitors during, or one month prior to the study
- •Use of new medications less than 4 weeks prior to the study.
- •Allergies to any of the ingredients used in the study
- •Any immune-compromising conditions
研究组 & 干预措施
Group A
Participants in group A will undergo challenges in the order:
- High-FODMAP beverage + placebo probiotic + L-Histidine
- Low-FODMAP beverage + placebo probiotic + L-Histidine
- High-FODMAP beverage + probiotic + L-Histidine
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: High-FODMAP beverage (Dietary Supplement)
Group A
Participants in group A will undergo challenges in the order:
- High-FODMAP beverage + placebo probiotic + L-Histidine
- Low-FODMAP beverage + placebo probiotic + L-Histidine
- High-FODMAP beverage + probiotic + L-Histidine
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: Low-FODMAP beverage (Dietary Supplement)
Group A
Participants in group A will undergo challenges in the order:
- High-FODMAP beverage + placebo probiotic + L-Histidine
- Low-FODMAP beverage + placebo probiotic + L-Histidine
- High-FODMAP beverage + probiotic + L-Histidine
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: Lactobacillus acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2. (Dietary Supplement)
Group A
Participants in group A will undergo challenges in the order:
- High-FODMAP beverage + placebo probiotic + L-Histidine
- Low-FODMAP beverage + placebo probiotic + L-Histidine
- High-FODMAP beverage + probiotic + L-Histidine
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: Placebo (Other)
Group B
Participants in group A will undergo challenges in the order:
- Low-FODMAP beverage + placebo probiotic + L-Histidine
- High-FODMAP beverage + probiotic + L-Histidine
- High-FODMAP beverage + placebo probiotic + L-Histidine.
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: High-FODMAP beverage (Dietary Supplement)
Group B
Participants in group A will undergo challenges in the order:
- Low-FODMAP beverage + placebo probiotic + L-Histidine
- High-FODMAP beverage + probiotic + L-Histidine
- High-FODMAP beverage + placebo probiotic + L-Histidine.
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: Low-FODMAP beverage (Dietary Supplement)
Group B
Participants in group A will undergo challenges in the order:
- Low-FODMAP beverage + placebo probiotic + L-Histidine
- High-FODMAP beverage + probiotic + L-Histidine
- High-FODMAP beverage + placebo probiotic + L-Histidine.
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: Lactobacillus acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2. (Dietary Supplement)
Group B
Participants in group A will undergo challenges in the order:
- Low-FODMAP beverage + placebo probiotic + L-Histidine
- High-FODMAP beverage + probiotic + L-Histidine
- High-FODMAP beverage + placebo probiotic + L-Histidine.
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: Placebo (Other)
Group C
Participants in group A will undergo challenges in the order:
- High-FODMAP beverage + probiotic + L-Histidine
- High-FODMAP beverage + placebo probiotic + L-Histidine
- Low-FODMAP beverage + placebo probiotic + L-Histidine.
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: High-FODMAP beverage (Dietary Supplement)
Group C
Participants in group A will undergo challenges in the order:
- High-FODMAP beverage + probiotic + L-Histidine
- High-FODMAP beverage + placebo probiotic + L-Histidine
- Low-FODMAP beverage + placebo probiotic + L-Histidine.
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: Low-FODMAP beverage (Dietary Supplement)
Group C
Participants in group A will undergo challenges in the order:
- High-FODMAP beverage + probiotic + L-Histidine
- High-FODMAP beverage + placebo probiotic + L-Histidine
- Low-FODMAP beverage + placebo probiotic + L-Histidine.
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: Lactobacillus acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2. (Dietary Supplement)
Group C
Participants in group A will undergo challenges in the order:
- High-FODMAP beverage + probiotic + L-Histidine
- High-FODMAP beverage + placebo probiotic + L-Histidine
- Low-FODMAP beverage + placebo probiotic + L-Histidine.
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: Placebo (Other)
Group C
Participants in group A will undergo challenges in the order:
- High-FODMAP beverage + probiotic + L-Histidine
- High-FODMAP beverage + placebo probiotic + L-Histidine
- Low-FODMAP beverage + placebo probiotic + L-Histidine.
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: L-Histidine (Dietary Supplement)
Group A
Participants in group A will undergo challenges in the order:
- High-FODMAP beverage + placebo probiotic + L-Histidine
- Low-FODMAP beverage + placebo probiotic + L-Histidine
- High-FODMAP beverage + probiotic + L-Histidine
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: L-Histidine (Dietary Supplement)
Group B
Participants in group A will undergo challenges in the order:
- Low-FODMAP beverage + placebo probiotic + L-Histidine
- High-FODMAP beverage + probiotic + L-Histidine
- High-FODMAP beverage + placebo probiotic + L-Histidine.
Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.
干预措施: L-Histidine (Dietary Supplement)
结局指标
主要结局
Metabolites in stool, urine and blood
时间窗: six weeks
Metabolites will be measured by LC-MS and ELISA at baseline and before and after each intervention.
次要结局
- Changes in IBS symptoms(six weeks)
- Levels of anxiety, depression and stress(six weeks)
- Expression of hdc gene by stool bacteria(six weeks)
- Changes in dietary intake(six weeks)
- Stool microbiota composition(six weeks)
- Worsening of IBS symptoms following High-FODMAP challenge(six weeks)
- Changes in general GI symptoms(six weeks)