CTRI/2019/06/019617尚未招募未知
A prospective, randomized, double blind, placebo-controlled study to evaluate the effects of LactoSpore® (Bacillus coagulans MTCC (5856))on functional gas & bloating symptoms.
Sami Labs Limited0 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
- 尚未招募
- 发起方
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 or female subjects ranging in age from 18 to 65 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.
- •2 Subjects with Small intestinal Bacterial Overgrowth with symptoms of abdominal discomfort, gas & bloating, distension etc.
- •3 Fulfilling Rome IV Diagnostic Criteria for Functional Abdominal Bloating/Distension. Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
- •a)Recurrent bloating and/or distention occurring, on average, at least 1 day per week; abdominal bloating and/or distention predominates over other symptoms.
- •4 Willingness to follow the protocol requirement as evidenced by written, informed consent.
- •5 Willingness to complete subject diaries and study questionnaires.
- •6 Agree not to use any medication (prescription and over the counter), including vitamins, proteins and minerals supplement during the course of this study.
- •7 Recurrent feeling of bloating or visible distension at least 3 days/month in the last 3 months.
- •8 Agree not to use any dairy product during the course of this study.
- •9 Willing to avoid the pre-biotic and pro-biotic food supplements, laxatives and foods having laxative effects during the study.
- •10 Gastrointestinal Symptom Rating Scale score >=5.
- •11 Able to give written informed consent.
- •12 Avoid high fibre diet
- •13 Willing to come for regular follow-up visits.
排除标准
- •1 Sufficient criteria for a diagnosis of functional dyspepsia or other functional GI disorder.
- •2 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
- •3 Significant abnormal findings as determined by screening, history, physical examination, vital signs (blood pressure, pulse rate, respiration rate) hematology, urinalysis.
- •4 Subjects with Gastrointestinal disorders or other digestive problems such as Crohnâ??s disease, short bowel, ulcerative colitis, constipation or Lactose Intolerance.
- •5 Subjects using GI medication to control the function of the gut, such as anti-spasmodic, pro-kinetic agents or laxatives.
- •6 Subjects who were under antibiotic medication past 21 days.
- •7 History or presence of significant alcoholism or drug abuse in the past one year.
- •8 Participation in a clinical study during the preceding 6 months.
- •9 History of malignancy or other serious disease.
- •10 Any contraindication to blood sampling.
- •11 Smoking or Consumption of tobacco products and Alcohol.
- •12 Subjects allergic to certain dietary supplements in related to Gastrointestinal Disorder.
- •13 Unexplained weight loss less than 3 months.
- •14 Blood or blood products donated in past 30 days prior to study supplement administration.
- •15 Female subjects on pregnancy and lactating women.
- •16 Female subjects with pre menstrual syndrome with gas and bloating and subjects with menopause.
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