Effect of 15g Daily Consumption of NUTRIOSE During 2 and 4 Weeks on Healthy Volunteers Microbiota and Digestive Tolerance.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clostridium Perfringens rate in stool
研究概览
简要总结
NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a "soluble dietary fiber." The objective of this research is to determine, among healthy subjects, the effect of this dietary fiber on changes in gut microbiota and digestive tolerance during a 28 days consumption. Microbiological analyzes will be performed by RT-PCR. Digestive tolerance will be measured by the intelligence of a questionnaire by volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 20 to 50 years,
- •BMI 18 to 25 kg/m2,
- •absence of known or scalable organic or psychiatric disease
- •no history of chronic gastrointestinal disease
- •having a bowel regularity (1-3 defecation per day, of normal consistency),
- •person without medication during the study (especially laxatives, anti diarrheal) (except contraceptives in women)
- •having normal laboratory hepatic and renal tests (ASAT, ALAT, GGT, urea, creatinine)
- •no pregnant nor nursing women
- •covered by Social Security
- •negative serology for hepatitis B/C and HIV
- •who signed the informed consent form
排除标准
- •persons abusing drugs (laxatives, anti-diarrheal)
- •person who doesn't want to stop taking food supplements containing pre- or probiotics during time of the study
- •person intolerant to gluten and / or allergic to wheat flour
- •person in vegetarian or vegan diet
- •Inclusion in another clinical study
- •subjects receiving over 4,500 Euros in the last 12 months (including the present study)
- •subjects presenting risk of non-compliance in the opinion of the recruiting doctor.
研究组 & 干预措施
NUTRIOSE
group of volunteers fed with NUTRIOSE
干预措施: NUTRIOSE FB06 (Dietary Supplement)
GLUCIDEX
gruop of volunteers fed with GLUCIDEX
干预措施: GLUCIDEX 21 (Dietary Supplement)
结局指标
主要结局
Clostridium Perfringens rate in stool
时间窗: D0 ; D14 ; D28
次要结局
- Lactobacteria rate in stool(D0 ; D14 ; D28)
- stool pH(D0 ; D14; D28)
- Firmicutes rate in stool(D0 ; D14 ; D28)
- Faecalibacterium prausnitzii rate in stool(D0 ; D14 ; D28)
- Eubacterium rectal rate in stool(D0 ; D14 ; D28)
- Bifidobacteria rate in stool(D0 ; D14 ; D28)
- Streptococcus rate in stool(D0 ; D14 ; D28)
- digestive tolerance(J0 to J28 (every day))
- total stool flora(D0 ; D14 ; D28)
- Clostridium coccoides rate in stool(D0 ; D14 ; D28)
- Shigella + E. Coli EIEC (ipaH gene) rate in stool(D0 ; D14 ; D28)
- Clostridium leptum rate in stool(D0 ; D14 ; D28)
- Bacteroidetes rate in stool(D0 ; D14 ; D28)
- Actinobacteria rate in stool(D0 ; D14; D28)
- Clostridium difficile typa A and B rate in stool(D0 ; D14 ; D28)
- E. Coli EIEC + EPEC (eae gene) rate in stool(D0 ; D14 ; D28)
- Yersinia Enterocolitica rate in stool(D0 ; D14 ; D28)
- Bacteroides rate in stool(D0 ; D14 ; D28)
- Enterococcus rate in stool(D0 ; D14 ; D28)
- Listeria Monocytogenes rate in stool(D0 ; D14 ; D28)
- E. Coli rate in stool(D0 ; D14 ; D28)
- Clostridium difficile rate in stool(D0 ; D14 ; D28)