CTRI/2018/05/014071已完成4 期
A prospective, randomized, double blind, placebo-controlled, parallel-group, comparative three arm study to evaluate the efficacy and safety of two probiotic formulations in subjects with functional intestinal gas symptoms.
Sanzyme Biologics Private Limited0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
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
- •Inclusion Criteria:
- •To be eligible for this trial, subjects must fulfill all inclusion criteria listed below:
- •1. Subjects of either gender between 18 to 60 years of age.(Both inclusive)
- •2. Subjects attending the out-patient department complaining of abdominal distress symptoms like gas, pain and abdominal distension (Pain score and discomfort score must be more than or equal to grade 1) as per GSRS Scale and SODA scale.
- •3. Subjects willing to provide informed consent.
- •4. Willingness and ability to comply with protocol and protocol scheduled visits.
- •5. Healthy as determined by physical examination, medical history, hematological and hepatic function tests.
- •6. Agrees to maintain dietary and exercise habits for the duration of the trial.
- •7. Agrees to avoid intake of probiotics, fibre supplements and unpasteurized bacteria fermented food including yogurt and cheese for the duration of the trial.
排除标准
- •Exclusion Criteria:
- •Subjects meeting any of the following exclusion criteria will not be eligible for participation in this trial:
- •1. Subjects with history or diagnosed with specific pathologies like short gut syndrome, food intolerance, inborn errors of metabolism, Crohns disease, short bowel, ulcerative colitis, Irritable Bowel Syndrome, constipation, or lactose intolerance.
- •2. Subjects using GI medications to control the function of the gut, such as anti-spasmodics, motility agents, pro-kinetic agents, or laxatives.
- •3. Subjects suffering from any other disorder that is likely to be the cause of abdominal symptoms
- •4. Subjects suffering from any disorder that is likely to interfere with their participation in the trial.
- •5. Subjects with psychological disorders, or using drugs or alcohol that might interfere with their compliance to trial requirements.
- •6. Participation in another investigational study within 30 days of the current study
- •7. Known hypersensitivity to any of the components of Investigational study treatments
- •8. Patients on antibiotic treatment or supplements that would interfere with the natural flora of the gut for treating GI symptoms in the past 4 weeks. (Anything that can affect the current state of the GI tract or possibly kill the probiotics)
- •9. Active heart disease, uncontrolled high blood pressure, renal or hepatic impairment, Type I or II diabetes, psychiatric and immune disorders, unstable thyroid disease, Parkinsons disease, a history of cancer, previous stomach or intestinal surgery.
- •10. Women who are pregnant, breastfeeding or planning to become pregnant during the duration of the trial.
- •11. Patients who have undergone abdominal surgery within the past 6 months.
研究者
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