NCT02920294已完成不适用
Modulation of Small Intestinal Microbial Composition and Activity,Systemic Immune Adaptation and Blood Transcriptional Changes Induced by 2-wks Consumption With 2 Fermented Milk Products;a Randomized,Exploratory,Cross-over,Double Blind,Controlled Study in Ileostomy Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Temporal microbial composition and activity in the small intestine in ileal effluent
研究概览
简要总结
To determine the small intestinal microbiota response in humans to dietary interventions for two consecutive weeks, and to relate this to parameters of intestinal barrier function and immune and metabolic responses in blood, as functional outcome parameters of host physiology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Ileostomy installed at least 3 years prior to participation
- •Free of any complications originating from the colectomy procedure for at least 1 yr prior to participation, with the exception of possible skin irritation at the location of the stoma
- •BMI from 18 till 28 kg/m2
- •Age from 18 till 70 years
- •Available for entire study protocol.
- •For female: If of child bearing potential, female subjects must be using or complying with methods of contraception (such as oral birth control pills, intra-uterine device, double barrier methods (like condoms and spermicide, etc.)
排除标准
- •• History of cardiovascular, respiratory, urogenital, hepatic, haematological / immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, laboratory assessments which might limit participation in or completion of the study protocol, and/or major surgery with the exception of total colectomy, hysterectomy and/or appendectomy.
- •Subject with known lactose intolerance or with known or suspected allergy or hypersensitivity to any component of the study product(s) (milk protein for example) + sucrose + rhamnose
- •Severe gastrointestinal symptoms. In case of mild gastrointestinal symptoms, the principal investigator and the medically responsible MD will judge eligibility to participate.
- •Removal of more than 15 cm of the ileum during or at any moment after the colectomy procedure
- •Abdominal surgery interfering with gastrointestinal function, upon judgment of the principal investigator and the medically responsible MD
- •Use of medication, including proton pump inhibitors, non-steroidal anti-inflammatory drugs interfering with endpoints (but except oral contraceptives), within 14 days prior to and during participation.
- •Consumption of any probiotic or prebiotic supplements or pre- and probiotics containing food products, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principal investigator), in the 4 weeks prior to the study and during study participation (E4 PreProbiotics).
- •Use of antibiotics in the 4 weeks prior to the start of study and during study participation
- •Prohibited use of pro-, pre- or synbiotics during study period and three months prior to start of study. A list with forbidden products will be provided'
- •History of any side effects towards intake of pro- or prebiotic supplements of any kind.
研究组 & 干预措施
Probiotic 1
Active Comparator
Fresh fermented dairy drink containing yoghurt ferments consumed as follows: one bottle (100g) OD for 14 consecutive days
干预措施: Probiotic 1 (Dietary Supplement)
Probiotic 2
Active Comparator
Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) OD for 14 consecutive days
干预措施: Probiotic 2 (Dietary Supplement)
Placebo
Placebo Comparator
Acidified dairy drink without ferments consumed as follows: one bottle (100g) OD for 14 consecutive days
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Temporal microbial composition and activity in the small intestine in ileal effluent
时间窗: 2 weeks intervention
The microbiome activity will be determined as a function of the diet by double strand cDNA production and random sequencing of mRNA enriched fractions of total effluent RNA obtained from the effluent samples at the start and end of each intervention period.
次要结局
- Peripheral blood metabolome profiles(2 weeks intervention)
- Number of participants with Gastrointestinal symptoms by Visual Analogue Scales(2 weeks intervention)
- Small intestinal permeability by a multi sugar test (urinary recovery of test sugars)(2 weeks intervention)
- Gene transcription response in blood by transcriptome patterns.(2 weeks intervention)
- The level of whole blood immune responsiveness to a panel of standardized stimuli ex vivo(2 weeks intervention)
- Short chain fatty acid profiles in ileal effluent(2 weeks intervention)
- Occurrence and severity of treatment related adverse events(2 weeks intervention)
- The levels of a panel of peripheral blood biomarkers related to immune, metabolic and hormonal status(2 weeks intervention)
- Morning urine metabolome profiles(2 weeks intervention)
- The relative survival of bacterial strains (colony forming unit enumeration on semi-selective culture plates)(2 weeks intervention)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
The Effect of Prebiotics on Endurance PerformanceMicrotiaNCT04946578Maastricht University34
已完成
2 期
Modulation of small intestinal microbial composition and activity, systemic immune adaptation and blood transcriptional changes induced by 2-wks consumption with 2 fermented milk products; a randomized, exploratory, cross-over, double blind, controlled study in ileostomy patientscolectomyileostomy10017943NL-OMON45768niversiteit Maastricht16
已完成
不适用
Dietary Modulation of Intestinal Microbiota as Trigger of Liver Health: Role of Bile Acids - "A Diet for Liver Health"NASH - Nonalcoholic SteatohepatitisNCT03897218RWTH Aachen University84
已完成
早期 1 期
Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint InhibitorsSolid TumorNCT04552418University of Michigan Rogel Cancer Center12
已完成
不适用
Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV PatientsHIVNCT02610374University of Colorado, Denver90