Proof of Concept Clinical Trial of Safety and Biological Activity of Bifidobacterium Longum NCC 2705 in Gluten Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Gastro-intestinal tolerability: visual analog scale
研究概览
简要总结
The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.
详细描述
This trial is a multicenter, double blind, randomized, placebo controlled, 2 by 2 cross-over design (i.e. 2-sequences, 2-periods, 2-treatments) for each specific population (i.e. self-reported Non Coeliac Gluten Sensitivity and Coeliac Disease subjects).
1 capsule of BL NCC 2705 or placebo will be given twice a day in the morning and in the evening with a meal over 2 periods of 4 days.
On day four a single dose of gluten (3g) will be administered and duodenal fluid will be collected in the following hours through a naso-intestinal catheter. The viability of BL NCC 2705, the production of serpin and its effects on gluten digestion and intestinal enzymatic activity will be determined.
No chronic administration of gluten as a challenge is foreseen in the study.
After a wash out period of minimum 2 weeks, period will be repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to sign written informed consent prior to trial entry
- •Male or female adults >18 years of age
- •For NCGS: self-reported gluten sensitivity with negative CD serology, on gluten free diet for at least 6 weeks with self-reported significant symptomatic improvement
- •For CD: confirmed serologic and histologic diagnosis of CD and on GFD for at least 12 months with self-reported significant symptomatic improvement
- •Body Mass Index (BMI) within the range >18 - <30 kg/m2
- •Willing and able to comply with study procedures and restrictions
- •In good health as determined by a medical history and medical examination
排除标准
- •Documented IgE-mediated food allergy
- •Subjects following an overly imbalanced or restrictive diet as per nutritional advice
- •Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be detrimental for the participants safety or potentially interfering with the study procedures and/or study outcomes
- •Concurrent organic GI pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli
- •Previous abdominal surgery with the exception of hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, hemorrhoidectomy
- •Patients who received antibiotics in the previous 2 weeks
- •women of childbearing potential not willing to use an effective contraception method
研究组 & 干预措施
Period 1: Placebo - Period 2: BL NCC 2705
For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)
干预措施: Intervention 1 : Maltodextrin (Other)
Period 1: Placebo - Period 2: BL NCC 2705
For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)
干预措施: Intervention 2 : BL NCC 2705 + Maltodextrin (Dietary Supplement)
Period 1: BL NCC 2705 - Period 2: Placebo
For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)
干预措施: Intervention 2 : Maltodextrin (Other)
Period 1: BL NCC 2705 - Period 2: Placebo
For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)
干预措施: Intervention 1 : BL NCC 2705 + Maltodextrin (Dietary Supplement)
结局指标
主要结局
Gastro-intestinal tolerability: visual analog scale
时间窗: from Baseline to end of study (up to maximum 43 days)
Sum of visual analog scale for gastro-intestinal symptoms assessment (nausea, vomiting, diarrhea, audible bowel sound, flatulence and abdominal cramping symptoms are assessed). Each scale is from 0 (no symptom) to 100mm (maximum symptom). The maximum sum value is 600.
incidence, type and severity of adverse event
时间窗: from Baseline to end of study (up to maximum 43 days)
incidence, type and severity of adverse event
次要结局
- Concentration of gluten derived pepides in urine(10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36))
- Concentration of gluten derived pepides in duodenal aspirates(10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36))
- Concentration of bacterial Serpin RNA and/or proteins (ng/mL) in duodenal aspirates(19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36))
- Concentration of Probiotic BL NCC 2705 (ng/mL) in duodenal aspirates(19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36))
- Level of elastase (Units/ mL) activity in duodenal aspirates(19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36))