The Beneficial Effects of a Novel Formulation of Bifidobacterium Longum BB536 and Lactobacillus Rhamnosus HN001 With Vitamin B6 on Gut Microbiota and Intestinal Permeability in IBS Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- MEDSTYLE questionnaire
研究概览
简要总结
Irritable bowel syndrome (IBS) is one of the most frequent functional gastrointestinal disorder with a prevalence ranging from 10 to 15 percent. IBS results from an interaction among several factors, including genetic predisposition, gastrointestinal motility, visceral hypersensitivity, immune activation with minimal inflammation, alterations in intestinal microbiota, increased intestinal permeability, and food sensitivity. Of note, the management of patients with IBS is critical. Since quantitative and qualitative disturbances of intestinal microbiota can occur in IBS, interesting data support the use of probiotics to modulate intestinal microbiota. The present study aimed to investigate the effects of a novel formulation of B. longum BB536 and L. rhamnosus HN001 with vitamin B6 on the gut microbiota and intestinal permeability in IBS subjects.
详细描述
Irritable bowel syndrome (IBS) is one of the most frequent functional gastrointestinal disorder with a prevalence ranging from 10 to 15 percent. It is characterized by recurrent chronic abdominal pain or discomfort in the absence of detectable organic causes with two or more of the following conditions: onset associated with a change in frequency of stool, onset associated with a change in form (appearance) of stool, or improvement with defecation.
IBS results from an interaction among several factors, including genetic predisposition, gastrointestinal motility, visceral hypersensitivity, immune activation with minimal inflammation, alterations in intestinal microbiota, increased intestinal permeability, and food sensitivity.
IBS is associated with a high economic burden for the health care costs and work absenteeism.
The disease course is represented by unchanged symptoms in 30 to 50 percent or progression of symptoms in 2 to 18 percent. On the other hand, an improvement in symptoms was recorded in 12 to 38 percent of patients.
Of note, the management of patients with IBS is critical. Several therapeutic options have been proposed looking to the underlying pathophysiological mechanisms (i.e., dietary modification, osmotic laxatives, lubiprostone, guanylate cyclase agonists, 5-hydroxytryptamine (serotonin) 4 receptor agonists, antidiarrheal agents, bile acid sequestrants, 5-hydroxytryptamine (serotonin) 3 receptor antagonists, antispasmodic agents, antidepressants, antibiotics, probiotics, behavior modification, anxiolytics, mast cell stabilizer, and fecal transplantation).
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
- None
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
- •Diagnosis of IBS according to Rome IV Criteria
排除标准
- •Diagnosis of structural abnormality of the GI tract
- •Inflammatory bowel disorders
- •Biliary duct obstructions
- •Gallstones
- •Abdominal surgery within the previous six months
- •Infective diseases
- •Drug or alcohol abuse
- •Metabolic disturbances
- •Mental illness
- •Concomitant immunological, haematological or neoplastic disease
- •Severe hepatic insufficiency (i.e., Child-Pugh class C)
- •Severe heart failure (NYHA class III-IV)
研究组 & 干预措施
Probiotic
The study design is a crossover randomized double-blind two-block placebo-controlled single center trial with an allocation ratio of 1:1 conducted between February 2017 and May 2018. Subjects are randomized at baseline visit to receive Block 1 (Zircombi 3 g, containing Bifidobacterium longum BB536 four billion CFU, Lactobacillus rhamnosus HN001 one billion CFU with B6 vitamin 1.4 mg) and Block 2 (placebo: maltodextrins, corn starch, silicon dioxide) depending on the randomization sequence. Subjects received one sachet pack daily containing placebo or probiotic. The active treatment was undistinguishable from placebo by physical and organoleptic characteristics. Participants in the study followed a free diet.
干预措施: Zircombi (Dietary Supplement)
Placebo
Same appearance of probiotic.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
MEDSTYLE questionnaire
时间窗: Baseline
A custom-designed questionnaire, tested across different ages, and anthropometric groups in health and disease, to measure anthropometric data, medical history, lifestyle and daily intake of foods. Frequency (day, week or month) and portion sizes (small, medium and large, represented by color pictures) of food consumption were estimated by using 35 food items (156 foods).The adherence to a Mediterranean diet was calculated by analyzing nine food categories with a score ranging from 0 point (lowest adherence) to 18 points (highest adherence).
Intestinal permeability
时间窗: Baseline
It was assessed by oral administration of four sugar probes, which selectively characterize the permeability from different tracts of the gastrointestinal system. Sucrose (SO) was used as a marker of gastro-duodenal permeability; lactulose (LA) and mannitol (MA) were used as markers of small intestine permeability also as (LA/MA), and sucralose (SU) as marker of 8 colonic permeability.
Community level catabolic profiles
时间窗: Baseline
Biolog Eco microplates (Biolog, Inc., Hayward, CA, USA) were used to estimate the microbial diversity.
Fecal metabolome
时间窗: Baseline
Three grams of fecal sample were placed into 10 mL glass vials and added with 10 μL of 4-methyl- 2-pentanol (final concentration of 33 mg/L) as the internal standard.
Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
时间窗: Baseline
Developed by Francis et al. (1997), and categorized as follows: remission (score \<75), mild (75-175), moderate (175-300) and severe (\>300).
Bristol Stool Form Scale (BSFS)
时间窗: Baseline
To assess bowel movements, consisting of a self-report instrument for classifying stool form into seven types ranging from "separate hard lumps like nuts" (type 1) to "watery, no solid pieces" (type 7)
Visual Analogue Scale, ranging from 0 to 100
时间窗: Baseline
For assessing abdominal pain and bloating
Cultivable intestinal microbiota
时间窗: Baseline
It was evaluated by faecal samples (5 g) were mixed with 45 mL sterilized physiological solution and homogenized.
次要结局
未报告次要终点
研究者
piero portincasa
Principal Investigator
University of Bari