A Multicentre, Randomized, Double Blind, Parallel Group, Placebo Controlled Clinical Trial to Evaluate Efficacy and Safety of Bacillus subtilis HU58 plus Bacillus coagulans SC208 Capsules in subjects with diarrhoea predominant Irritable Bowel Syndrome (IBS-D).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- Percentage of subjects defined as responders for abdominal pain and stool consistency from baseline to end of study.
研究概览
简要总结
This study is a Randomized, Double Blind, Parallel Group, Placebo Controlled Clinical Trial to Evaluate Efficacy and Safety of Bacillus subtilisHU58 + Bacillus coagulans SC208 Capsules in subjects with diarrhoea predominant Irritable Bowel Syndrome(IBS-D).
The randomization visit will be conducted on Day 1 after 7 days of the screening period (Visit 1) wherein the subject will be randomized after assessing the diary scores for eligibility.
Eligible subjects will be randomized in two arms in ratio 1:1.The follow up visits will be conducted on Visit 2 (Day 8±1) Visit 3 (Day 15±1) Visit 4 (Day 22±1) and end of study visit will be conducted at Visit 5 (Day 29±1). A Post Treatment Safety Follow up visit will be conducted at Visit 6 (Day 36±2). The duration of individual participation will be approximately 43 days.
The primary outcome evaluates Percentage of participants defined as responders for abdominal pain and stool consistency from baseline to end of study.
The secondary outcome evaluates Percentage of subjects who were responders for abdominal pain, Percentage of subjects who were responders for Stool Consistency Scores, Change in Stool Change in Perceived Stress Scale (PSS),Percentage of IBS Global Assessment of Improvement Scale (IBS-GAI) responders, Change in stool sample measurement Short-chain fatty acids SCFAs levels and Changes in diversity of gut microbiota observed through DNA extraction and 16S rRNA gene sequencing from baseline to the end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Male or Female subjects between 18 to 65 years of age both inclusive.
- •Subjects 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 categorized as stool form type 6 or 7 (diarrhoea) and <25% as stool form type 1 or 2 constipation) on Bristol stool form scale (BSFS).
- •Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
- •At end of screening period.
- •Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score of ≥ 3.0 on a 0 to 10-point scale and.
- •At least one stool with a consistency of Type 6 or Type 7 Bristol stool score (BSS) on at least 2 days per week).
排除标准
- •Subjects with Constipation-predominant irritable bowel syndrome (IBS), or diarrhoea other than that associated with IBS.
- •Subjects with known hypersensitivity to any of the ingredients in the probiotic product or the placebo.
- •Subjects with a history of coeliac disease, Inflammatory Bowel disease, bowel cancer, bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.
- •Subjects with history of unexplained weight loss or rectal bleeding.
- •Subjects with acute GI tract infection
- •Subjects requiring antibiotics for the treatment of Diarrhoea
- •Subjects with Type 1 Diabetes or Uncontrolled Type 2 Diabetes Mellitus.
- •Subjects with 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.
- •Use of antidepressant agents, unless used at a stable dose for at least 2weeks prior to screening.
- •Subjects with current evidence of clinically significant severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, hematopoietic, Neurologic, psychiatric, autoimmune disease and other relevant systemic diseases that would preclude the safe administration of the Investigational product.
- •Subjects with history of HIV or hepatitis B or hepatitis C at screening visit.
- •Subjects with a history of food allergies and lactose intolerance.
- •Subject with history of alcohol or drug abuse in the past 3 months prior to screening visit.
- •Subjects with a history of intake of Any Probiotic, Prebiotic, symbiotic containing formulations, antibiotics (Rifaximin, metronidazole, or any other), Bile acid sequestrants(Cholestyramine ,Colesevelam and Colestipol), 5-hydroxytryptamine (serotonin) 3 receptor antagonists (such as Alosetron) and Eluxadoline within two weeks prior to the screening day.
- •Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
- •Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •Suspected inability or unwillingness to comply with the study procedures.
结局指标
主要结局
Percentage of subjects defined as responders for abdominal pain and stool consistency from baseline to end of study.
时间窗: 28 Days
次要结局
- Percentage of subjects who were responders for abdominal pain from baseline to the end of study.(28 Days)
- Percentage of subjects who were responders for Stool Consistency Scores from baseline to the end of study.(28 Days)
- Change in Stool Consistency (Bristol stool score (BSS) from baseline to the end of study(28 Days)
- Change in Abdominal Pain Intensity (0 to 10 point NRS scale) from baseline to the end of study.(28 Days)
- Change in stool sample measurement for Short-chain fatty acids SCFAs levels from baseline to the end of study(28 Days)
- Change in Perceived Stress Scale (PSS) from baseline to the end of study.(28 Days)
- Percentage of IBS Global Assessment of Improvement Scale (IBS-GAI) responders from baseline to the end of study.(28 Days)
- Changes in diversity of gut microbiota observed through DNA extraction and 16S rRNA gene sequencing from baseline to the end of study(28 Days)