NCT05339243已完成不适用
Evaluating the Safety and Efficacy of the Probiotic Bifidobacterium Longum ES1 and the Post Biotic Heat-treated Bifidobacterium Longum ES1 (HT-ES1) on IBS Symptom Severity in Patients With Diarrhoea Predominant Irritable Bowel Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Irritable Bowel Syndrome-Symptom Severity Scale
研究概览
简要总结
Randomized controlled clinical study has been proposed to evaluate the safety and efficacy of ES1 probiotic strain and heat-treated ES1 postbiotic strain in individuals suffering from IBS-D.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged ≥18 to ≤ 65 years.
- •Participants diagnosed with diarrhoea-predominant irritable bowel syndrome (IBS-D) as per ROME IV criteria:
- •i) Recurrent abdominal pain on average at least one day/week in the last three months, associated with two or more of the following criteria: Related to defecation Associated with a change in stool frequency (increase/decrease in frequency). Associated with a change in the form (appearance) of stool. ii) History of abnormal bowel movements predominantly diarrhoea (>25% of bowel movement categorised as stool form type 6 or 7 (diarrhoea) and <25% as stool form type 1 or 2 constipation) on BSFS).
- •Participants with an IBS-SSS score ≥
- •Participants who test negative for COVID-19 by Rapid Antigen Lateral Flow Test Device.
- •Participants who can comply and perform the procedures as per the protocol (consumption of study medications, biological sample collection procedures, and study visit schedule).
- •Female participants who are willing to use acceptable contraceptives during the study duration.
- •Participants who are literate enough to understand the purpose of the study and their rights.
- •Participants who are able to give written informed consent and are willing to participate in the study.
排除标准
- •Participants diagnosed with anxiety as assessed by STAI-AD S- anxiety subscale score ≥
- •Gluten and/or lactose intolerant individuals.
- •Abnormal Thyroid Stimulating Hormone (TSH) value which is (< 0.4 to > 4.2 mIU/L).
- •Participants with uncontrolled type II diabetes mellitus defined as random blood glucose (RBG) > 199 mg/dL or fasting blood glucose (FBG) >125 mg/dL.
- •Participants with a body mass index (BMI) ≥ 30 kg/m
- •Presence of uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg.
- •Participants with a history of intake of antibiotics (Rifaximin, metronidazole, or any other), other probiotics, prebiotics, synbiotic, proton pump inhibitors, acid sequestrants (cholestyramine, Bile colestipol), FODMAP diet, and histamine H2- receptor antagonists/H2 blockers within six weeks prior to the screening day.
- •Participants with a history of daily intake of antidepressants (Tricyclic antidepressants, Selective serotonin reuptake inhibitors (SSRIs), and Selective serotonin-norepinephrine reuptake Inhibitors (SSNRIs)), clonidine, otilonium bromide, asimadoline, eluxadoline, diphenoxylate, antispasmodics including mebeverine and pinnaverium and anticholinergics within two weeks before the screening day.
- •Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.
- •Participants showing signs of bile acid malabsorption (BAM), as evident from the history of green colour or foul odour of the stool during the last month.
- •Participants with a history of or complications from malignant tumours.
- •Participation in other clinical trials in the last 90 days prior to screening
- •Active smokers or using any form of smokeless tobacco.
- •Participants with substance abuse problems (within two years) defined as:
- •Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- •High-risk drinking as defined by the consumption of four or more alcohol-containing beverages on any day or eight or more alcohol- containing beverages per week for women and five or more alcohol-containing beverages on any day or 15 or more alcohol- containing beverages per week for men.
- •Participants having clinically significant illnesses of cardiovascular, endocrine, immune, respiratory, hepato-biliary, kidney and urinary, haematological, musculoskeletal system and/or any inflammatory disorder, tumour, and other gastrointestinal diseases.
结局指标
主要结局
Irritable Bowel Syndrome-Symptom Severity Scale
时间窗: day 0, 28, 56, and 84
To determine the efficacy of investigational products on the participants global assessment of gastrointestinal symptoms, as assessed by change in Irritable Bowel Syndrome-Symptom Severity Scale total score at the end of study from baseline compared to placebo. Each of these 5 items is scored on a visual analogue scale from 0 to 100. Therefore, the total score on the ranges from 0 to 500. Participants are asked to respond to each question on a 100-point visual analogue scale. The higher the scores, the more will be the severity of symptoms. Participants, if required, can be categorized as having mild (75-175), moderate (175-300), Higher the score is the worst outcome and lower the score is the betterment.
次要结局
- Gut microbiome as assessed by 16S rRNA sequencing of faecal samples.(day 0 and 84)
- Bristol Stool Form Scale(day 0, 28, 56, and 84)
- Irritable Bowel Syndrome-Quality of Life(day 0, 28, 56, and 84)
- Abdominal Pain Severity-Numeric Rating Scale score.(day 0, 28, 56, and 84)
- State-Trait Anxiety Inventory-Adults score.(day 0, 28, 56, and 84)
- Vitals - blood pressure(day 0, 28, 56, and 84)
- Vitals - Pulse Rate(day 0, 28, 56, and 84)
研究者
研究点 (16)
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