CTRI/2022/04/041875已完成不适用
Evaluating the safety and efficacy of the probiotic Bifidobacteriumlongum ES1 and the post biotic heat-treated Bifidobacterium longumES1 (HT-ES1) on IBS symptom severity in patients with diarrhoea predominant Irritable Bowel Syndrome
Dr Malwina Naghibi7 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年4月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- from baseline compared to placebo.
研究概览
简要总结
The present randomised controlled clinical study has been proposed to evaluate the safety andefficacy 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
- Stratified block randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Males and females aged ≥18 to ≤ 65 years.
- •2 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).
- •3 Participants with an IBS-SSS score ≥
- •4 Participants who test negative for COVID-19 by Rapid Antigen Lateral Flow Test Device.
- •5 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.
- •7 Participants who are able to give written informed consent and are willing to participate in the study.
排除标准
- •1 Participants diagnosed with anxiety as assessed by STAI-AD S- anxiety subscale score ≥
- •2 Gluten and/or lactose intolerant individuals.
- •3 Abnormal Thyroid Stimulating Hormone (TSH) value which is (< 0.4 to > 4.2 mIU/L).
- •4 Participants with uncontrolled type II diabetes mellitus defined as random blood glucose (RBG) > 199 mg/dL or fasting blood glucose (FBG) >125 mg/dL.
- •5 Participants with a body mass index (BMI) ≥ 30 kg/m
- •6 Presence of uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg. 7 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.
- •8 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.
- •9 Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.
- •10 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.
- •11 Participants with a history of or complications from malignant tumours.
- •12 Participation in other clinical trials in the last 90 days prior to screening 13 Active smokers or using any form of smokeless tobacco.
- •14 Participants with substance abuse problems (within two years) defined as: 15 Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- •16 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.
- •17 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
from baseline compared to placebo.
时间窗: day 0, 28, 56, and 84
To determine the efficacy of investigational products on the participants
时间窗: day 0, 28, 56, and 84
global assessment of gastrointestinal symptoms, as assessed by change in
时间窗: day 0, 28, 56, and 84
IBS-Symptom Severity Scale (IBS-SSS) total score at the end of study
时间窗: day 0, 28, 56, and 84
次要结局
- Quality of life as assessed by change in IBS-Quality of Life(day 0, 28, 56 and 84)
- Mental health as assessed by change in State-Trait Anxiety(Inventory-Adults (STAI-AD) score.)
- Percentage of the population achieving normal stool consistency(defined as l stool form type 3, 4, and 5 on Bristol Stool Form Scale)
- Vitals – blood pressure (BP) and pulse rate (PR).(day 0, 28, 56, and 84)
- The number of adverse events (AE)/serious adverse events (SAE)(occurred during the study compared to placebo.)
- Abdominal pain severity as assessed by change in Abdominal Pain(Severity-Numeric Rating Scale (APS-NRS) score.)
- Gut microbiome as assessed by 16S rRNA sequencing of faecal(samples.)
- Laboratory parameters (Alanine aminotransferase (ALT), Aspartate(aminotransferase (AST), Alkaline phosphatase (ALP), and)
研究者
研究点 (7)
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