NCT05054309已完成不适用
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome
Société des Produits Nestlé (SPN)22 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2022年2月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 22
- 主要终点
- To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Gastrointestinal Symptoms
研究概览
简要总结
This is a prospective, randomized, placebo-controlled, double-blind, multi-center parallel- design study to evaluate the effect of BL NCC3001 in subjects with Irritable Bowel Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Male or female, age between 18 and 70 years inclusive.
- •Willing and able to sign written informed consent prior to study entry.
- •Able to comply with the study procedures, in the opinion of the investigator.
- •Subjects diagnosed with IBS. All subtypes based on Rome IV Criteria with active IBS symptoms as indicated by a score of ≥ 125 on the IBS-SSS.
- •Subjects with psychological symptoms in the absence of a psychiatric diagnosis, defined as a score of 5 to 13 in the depression domain and/or a score of 4 to 9 in the anxiety domain of the DASS-21 questionnaire.
排除标准
- •Concurrent formal diagnosis by a psychiatric specialist, including any mood or anxiety disorder, according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th or 5th edition.
- •Concurrent systemic disease and/ or laboratory abnormalities considered by the investigator to be clinically relevant or that could interfere with data collection or interpretation.
- •Concurrent organic gastrointestinal pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas, and melanosis coli.
- •History of attempted suicide in the past 5 years.
- •Previous abdominal surgery except for hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, and hemorrhoidectomy.
- •History of substance abuse in the past 2 years, including opiates, phencyclidine, benzodiazepines, amphetamines, cocaine, heroin, alcohol, and cannabinoids (except if medically indicated).
- •Subjects who are on daily treatment with therapeutic doses of drugs having central nervous system effects, including antidepressants and/ or anxiolytics. Low doses of (I) tricyclic antidepressants for abdominal pain/diarrhea related to IBS and (II) anxiolytics used as sleeping pills will be permitted if dose is stable > 3 months prior to the date of randomization.
- •Pregnant or breastfeeding women.
- •Subjects with dementia or other cognitive impairment.
- •Subjects who received antibiotics within the 4 weeks prior to the date of randomization .
- •Known or suspected allergies to the study products.
- •Subjects with increased risk of probiotic sepsis as the following conditions: Immune compromise, including debilitating state or malignancy, central venous catheter, impaired intestinal epithelial barrier (acute diarrheal illness, intestinal inflammation, etc.), cardiac valvular disease.
- •Subjects currently participating or having participated in a therapeutic trial within 3 months prior to the date of randomization.
- •Medically diagnosed lactose intolerance and fructose intolerance without being on a stable lactose or fructose free diet (> 3 months prior to the date of randomization).
- •Medically diagnosed celiac disease.
- •Consumption of any probiotic supplements specified as containing Lactobacillus, Bifidobacteria, Streptococcus, Bacillus coagulans, and Saccharomyces at least 2 weeks prior to the date of randomization.
- •Subjects on regular use of drugs to control IBS symptoms such as bile acid binders (cholestyramine, colestipol or colesevelam, rifaximin, alosetron, lubiprostone, eluxadoline and linaclotide).
- •Recently initiated exclusion diets. Subjects on stable exclusion diets (> 3 months prior to the date of randomization) will not be excluded. This includes subjects with the following diets: gluten-free, lactose-free, paleo, vegetarian, vegan, and low-carbohydrate.
- •Low-FODMAP diet. Subjects on the induction phase of the FODMAP exclusion will not be enrolled. Subjects on the maintenance phase of the diet for more than 3 months prior to the date of randomization with stable diet can be considered for enrollment.
结局指标
主要结局
To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Gastrointestinal Symptoms
时间窗: Baseline to 6 weeks.
Change from baseline to week 6 in Irritable Bowel Severity Scoring System (IBS-SSS), a questionnaire that includes 5 questions related to the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. This cumulative score can therefore range from 0 to 500, with higher scores indicating more severe symptoms.
To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Psychological Symptoms
时间窗: Baseline to 6 weeks.
Change from baseline to week 6 in Hospital Anxiety and Depression Scale (HADS-Total) score, a 14-item scale assessing two dimensions (anxiety and depression, 7 items for each) of psychological distress. Each item is scored from 0-3 in a Likert manner. Outcome measures are the anxiety score (0-21), depression score (0-21) and the total score (0-42).
次要结局
- Irritable Bowel Severity Scoring System (IBS-SSS) Pain severity(Day -1, Day 43 (± 2 days))
- Patient Health Questionnaire (PHQ-12)(Day -1, Day 43 (± 2 days))
- Perceived Stress Scale (PSS)(Day -1, Day 43 (± 2 days))
- Irritable Bowel Severity Scoring System (IBS-SSS) Pain frequency(Day -1, Day 43 (± 2 days))
- Irritable Bowel Severity Scoring System (IBS-SSS) Bloating severity(Day -1, Day 43 (± 2 days))
- Hospital Anxiety Depression Scale - Depression (HADS-D) score(Day -1, Day 43 (± 2 days))
- Hospital Anxiety Depression Scale - Anxiety (HADS-A) score(Day -1, Day 43 (± 2 days))
- Depression Anxiety Stress Scale (DASS-21)(Day -1, Day 43 (± 2 days))
- Psychological distress improvement according to the Patient's Global Impression of Change of "Psychological Distress"(Day 43 (± 2 days))
- Irritable Bowel Severity Scoring System (IBS-SSS) Bowel habit(Day -1, Day 43 (± 2 days))
- Irritable Bowel Severity Scoring System (IBS-SSS) Life impact(Day -1, Day 43 (± 2 days))
- Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QoL)(Day -1, Day 43 (± 2 days))
- Sheehan Disability Scale (SDS)(Day -1, Day 43 (± 2 days))
- Amount of Bifidobacterium Longum (BL NCC3001) present in stool(Day -1, Day 43 (± 2 days))
- Irritable Bowel Severity Scoring System (IBS-SSS) score(Day -1, Day 71 (± 2 days))
- Hospital Anxiety Depression Scale (HADS) total score(Day -1, Day 71 (± 2 days))
- Rescue Medication(Day 43 (± 2 days))
- Active treatment randomization perception: "Do you think you have taken the placebo or active treatment?"(Day 43 (± 2 days))
研究者
研究点 (22)
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