A randomized, double blind, parallel group, placebo controlled study to evaluate the safety and efficacy of LactoSpore® (Bacillus coagulans) in patients with diarrhea predominant Irritable Bowel Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Safety Outcome -
研究概览
简要总结
A randomized, double blind,parallel group, placebo controlled study to evaluate the safety and efficacy ofLactoSpore® (Bacillus coagulans) in patients with diarrhea predominantIrritable Bowel Syndrome and will be conducted in 3 centers in India. The Primaryoutcome will be to access the safety and efficacy of LactoSpore® (Bacilluscoagulans) for a treatment period of 90 days. 36 randomized patients will begiven a tablet each either of LactoSpore® or a placebo. Study evaluations willbe conducted as per the study protocol. All adverse events will be recorded andsafety parameters evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects ranging in age from 18 to 55 years (both inclusive) diagnosed as having gastro intestinal disorders and based on the medical history record will be included in the study by the Investigator.
- •Fulfilling Rome III Diagnostic Criteria for Functional IBS (Functional Diarrhea)
- •Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis a) Recurrent abdominal pain or discomfort (uncomfortable sensation not described as pain) at least 3 days/month in the last 3 months associated with two or more of the following: i.
- •Improvement with defecation ii.
- •Onset associated with a change in frequency of stool iii.
- •Onset associated with a change in form (appearance) of stool b) Recurrent feeling of bloating or visible distension at least 3 days/month in the last 3 months c) Loose (mushy) or watery stools without pain occurring in at least 75% of stools
- •Willingness to follow the protocol requirement as evidenced by written, informed consent.
- •Willingness to complete subject diaries and respond to study questionnaires.
- •Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study.
- •Agree not to use any yogurt during the course of this study.
- •Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range.
- •Subject’s assurance that they have not taken antibiotics or other drugs whose primary site of action is in the GIT for a period up to 1 month prior to the start of the study.
排除标准
- •Sufficient criteria for a diagnosis of functional dyspepsia or other functional GI disorder.
- •Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
- •Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate) hematology, serum chemistry, urinalysis.
- •History or presence of significant alcoholism or drug abuse in the past one year.
- •Participation in a clinical study during the preceding 90 days.
- •History of malignancy or other serious disease.
- •Any contraindication to blood sampling.
- •Smoking or Consumption of tobacco products.
- •Blood or blood products donated in past 30 days prior to study supplement administration.
- •Female subjects on pregnancy and lactating women.
结局指标
主要结局
Safety Outcome -
时间窗: Safety Outcome - | 1] Physical Examination and vitals (Screening, Day 0, Day 30, Day 60 and Day 90) | 2] Adverse events, if any (All visits) | 3] Abnormal laboratory parameters (Screening and Day 90) | Efficacy Outcomes - | 1] 10 cm VAS (Day 0, Day 30, Day 60 and Day 90) | 2] Gastro intestinal discomfort questionnaire(Day 0, Day 30, Day 60 and Day 90). | 3]Bristol Stool Form Score(Day 0, Day 30, Day 60 and Day 90).
2] Assessment of reported adverse events, if any
时间窗: Safety Outcome - | 1] Physical Examination and vitals (Screening, Day 0, Day 30, Day 60 and Day 90) | 2] Adverse events, if any (All visits) | 3] Abnormal laboratory parameters (Screening and Day 90) | Efficacy Outcomes - | 1] 10 cm VAS (Day 0, Day 30, Day 60 and Day 90) | 2] Gastro intestinal discomfort questionnaire(Day 0, Day 30, Day 60 and Day 90). | 3]Bristol Stool Form Score(Day 0, Day 30, Day 60 and Day 90).
1] Physical Examination and vitals
时间窗: Safety Outcome - | 1] Physical Examination and vitals (Screening, Day 0, Day 30, Day 60 and Day 90) | 2] Adverse events, if any (All visits) | 3] Abnormal laboratory parameters (Screening and Day 90) | Efficacy Outcomes - | 1] 10 cm VAS (Day 0, Day 30, Day 60 and Day 90) | 2] Gastro intestinal discomfort questionnaire(Day 0, Day 30, Day 60 and Day 90). | 3]Bristol Stool Form Score(Day 0, Day 30, Day 60 and Day 90).
3] Assessment for any abnormal laboratory parameters
时间窗: Safety Outcome - | 1] Physical Examination and vitals (Screening, Day 0, Day 30, Day 60 and Day 90) | 2] Adverse events, if any (All visits) | 3] Abnormal laboratory parameters (Screening and Day 90) | Efficacy Outcomes - | 1] 10 cm VAS (Day 0, Day 30, Day 60 and Day 90) | 2] Gastro intestinal discomfort questionnaire(Day 0, Day 30, Day 60 and Day 90). | 3]Bristol Stool Form Score(Day 0, Day 30, Day 60 and Day 90).
1] Self assessment of abdominal pain, measured on a 10 cm VAS
时间窗: Safety Outcome - | 1] Physical Examination and vitals (Screening, Day 0, Day 30, Day 60 and Day 90) | 2] Adverse events, if any (All visits) | 3] Abnormal laboratory parameters (Screening and Day 90) | Efficacy Outcomes - | 1] 10 cm VAS (Day 0, Day 30, Day 60 and Day 90) | 2] Gastro intestinal discomfort questionnaire(Day 0, Day 30, Day 60 and Day 90). | 3]Bristol Stool Form Score(Day 0, Day 30, Day 60 and Day 90).
2] Bloating and distension, measured by Gastro intestinal discomfort questionnaire
时间窗: Safety Outcome - | 1] Physical Examination and vitals (Screening, Day 0, Day 30, Day 60 and Day 90) | 2] Adverse events, if any (All visits) | 3] Abnormal laboratory parameters (Screening and Day 90) | Efficacy Outcomes - | 1] 10 cm VAS (Day 0, Day 30, Day 60 and Day 90) | 2] Gastro intestinal discomfort questionnaire(Day 0, Day 30, Day 60 and Day 90). | 3]Bristol Stool Form Score(Day 0, Day 30, Day 60 and Day 90).
Efficacy Outcomes -
时间窗: Safety Outcome - | 1] Physical Examination and vitals (Screening, Day 0, Day 30, Day 60 and Day 90) | 2] Adverse events, if any (All visits) | 3] Abnormal laboratory parameters (Screening and Day 90) | Efficacy Outcomes - | 1] 10 cm VAS (Day 0, Day 30, Day 60 and Day 90) | 2] Gastro intestinal discomfort questionnaire(Day 0, Day 30, Day 60 and Day 90). | 3]Bristol Stool Form Score(Day 0, Day 30, Day 60 and Day 90).
3] Subjective evaluation using Bristol Stool Form Score
时间窗: Safety Outcome - | 1] Physical Examination and vitals (Screening, Day 0, Day 30, Day 60 and Day 90) | 2] Adverse events, if any (All visits) | 3] Abnormal laboratory parameters (Screening and Day 90) | Efficacy Outcomes - | 1] 10 cm VAS (Day 0, Day 30, Day 60 and Day 90) | 2] Gastro intestinal discomfort questionnaire(Day 0, Day 30, Day 60 and Day 90). | 3]Bristol Stool Form Score(Day 0, Day 30, Day 60 and Day 90).
次要结局
- 1] Physicians Global Assessment(2] Irritable Bowel Syndrome Quality of Life Questionnaire)