CTRI/2022/07/044154已完成未知
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).
Synergia Life Sciences Pvt Ltd A Novozymes One Health Company0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
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研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or Female subjects between 18 to 65 years of age both inclusive.
- •2. 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).
- •3. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
- •4. 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
- •1. Subjects with Constipation-predominant irritable bowel syndrome (IBS), or diarrhoea other than that associated with IBS.
- •2. Subjects with known hypersensitivity to any of the ingredients in the probiotic product or the placebo.
- •3. 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.
- •4. Subjects with history of unexplained weight loss or rectal bleeding.
- •5. Subjects with acute GI tract infection
- •6. Subjects requiring antibiotics for the treatment of Diarrhoea
- •7. Subjects with Type 1 Diabetes or Uncontrolled Type 2 Diabetes Mellitus.
- •8. 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.
- •9. Use of antidepressant agents, unless used at a stable dose for at least 2weeks prior to screening.
- •10. 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.
- •11. Subjects with history of HIV or hepatitis B or hepatitis C at screening visit.
- •12. Subjects with a history of food allergies and lactose intolerance.
- •13. Subject with history of alcohol or drug abuse in the past 3 months prior to screening visit.
- •14. 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.
- •15. 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.
- •16. Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •17. Suspected inability or unwillingness to comply with the study procedures.
研究者
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