CTRI/2015/05/005754已完成未知
A randomized, double blind, placebo controlled, multi center study to evaluate the efficacy of LactoSpore® (containing Bacillus coagulans MTCC5856) for Major Depressive Disorder in IBS patients.
Sami labs Limited0 个研究点目标入组 40 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
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and/or female subjects ranging in age between 20 to 65 years.
- •2. Fulfilling Rome III Diagnostic Criteria for Functional IBS (Functional Diarrhoea).
- •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
- •3.Willingness to follow the protocol requirement as evidenced by written, informed consent.
- •Newly diagnosed, IBS patients mild to moderate in severity with possible sleep, pain and dementia associated co morbidities.
- •4.Willingness to complete subject diaries and study questionnaires.
- •5.Agree not to use any medication (prescription and over the counter), including vitamins and
- •minerals, during the course of this study.
- •6.Agree not to use any yogurt during the course of this study.
- •7.Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range.
- •8.Subjectâ??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.
- •9.Willing to come for regular follow-up visits.
排除标准
- •1.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.
- •2.Significant abnormal findings as determined by baseline history, physical examination,vital signs(blood pressure, pulse rate, respiration rate) hematology, serum chemistry,urinalysis.
- •3.History or presence of significant alcoholism or drug abuse in the past one year.
- •4.Any medical or surgical conditions, which might significantly, interfere with the gastro intestinal tract, liver, kidneys, and/or blood-forming organs.
- •5.History of cardiovascular, renal, hepatic, asthma, glaucoma, pulmonary, neurologic,metabolic or psychiatric disease.
- •6.Participation in a clinical study during the preceding 90 days.
- •7.History of malignancy or other serious disease.
- •8.Any contraindication to blood sampling.
- •9.Smoking or Consumption of tobacco products.
- •10.Blood or blood products donated in past 30 days prior to study supplement
- •administration.
- •11.Female subjects on pregnancy and lactating women.
- •12.Prior surgical therapy for obesity.
- •13.Patients using yogurt in their daily meal.
研究者
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