NCT05754177已完成不适用
Evaluating the Safety and Efficacy of a Probiotic on IBS Symptom Severity in Adults With Diarrhoea-predominant Irritable Bowel Syndrome
The Archer-Daniels-Midland Company1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2023年6月6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
- 46
- 试验地点
- 1
- 主要终点
- Change in total irritable bowel syndrome symptom severity score (IBS-SSS)
研究概览
简要总结
This study aims to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with diarrhea-predominant Irritable Bowel Syndrome (IBS-D).
详细描述
This is a double-blind, randomised, placebo-controlled trial designed to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with IBS-D, when consumed orally in capsule form once daily for 84 days. Volunteers will be screened in order to identify up to 134 participants meeting ROME IV criteria for IBS-D. The study will involve 5 visits over a total of 105 days [visit 1: screening, commencement of run in period (-21 to -14 days), visit 2: baseline/ randomisation (day 0), visits 3 and 4: intervention period (day 28 ± 2, day 56 ± 2), visit 5: end of study (day 84± 2)]. Participants will fill in daily and weekly eDiaries, and questionnaires will be administered at study visits. Faecal samples will be collected on visits 2 and 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 是
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 movements 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 Test Device.
- •Participants who did not change their diet within three months before the screening day and are willing to sustain that diet during the study.
- •Participants who can comply and perform the procedures as per the protocol (consumption of study products, biological sample collection procedures, and study visit schedule).
- •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 who score ≥ 40 in either the 'state' or 'trait' section of the STAI-AD questionnaire (both sections to be assessed).
- •Participants diagnosed with Coeliac Disease.
- •Lactose intolerant participants unless on a strict lactose free diet for at least three months before screening day with persistent symptoms of IBS-D.
- •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, synbiotics, food supplements with iron or calcium, peppermint oil, acid sequestrants (cholestyramine, Bile colestipol), introduced/active low 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 prior to the screening day.
- •Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.
- •Participants with a history of gastrointestinal-related abdominal surgery other than hernia repair.
- •Participants with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis.
- •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 GI malignant tumours.
- •Participants with a history of or complications from other malignant tumours in the last 5 years.
- •History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's endpoints.
- •Participation in other clinical studies in the last 90 days prior to screening day.
- •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 and other gastrointestinal diseases.
- •Participants with active human immunodeficiency virus (HIV) or hepatitis A, B or C infection.
- •Female participants being pregnant, breastfeeding or planning pregnancy in the course of the study.
- •Any condition that could, in the opinion of the Investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.
结局指标
主要结局
Change in total irritable bowel syndrome symptom severity score (IBS-SSS)
时间窗: Day 0, Day 28, Day 58 and Day 84
Change in IBS-SSS totals score (max 500 points) from baseline to day 28, day 58 and day 84, where higher scores mean worse outcomes
次要结局
- Use of Rescue Medication(Day 0, Day 84)
- Percentage of population achieving a normal stool consistency(Day 0, Day 28, Day 58 and Day 84)
- Percentage of population without diarrhea(Weekly)
- Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) score(Day 0, Day 28, Day 58 and Day 84)
- Change in State-Trait Anxiety Inventory for Adults (STAI-AD) score(Day 0, Day 28, Day 58 and Day 84)
- Gut microbiome compositional changes(Day 0, Day 84)
研究者
研究点 (1)
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