A Randomized Double-Blind Placebo Controlled Three Arm Study to Evaluate the Role Of HPPE-092402 In Ameliorating Gut Health in Adults with Mild to Moderate Gastrointestinal Symptoms.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Safety and Efficacy Assessment of Gastrointestinal tolerability through GSRS (Gastrointestinal Symptoms Rating Scale).
研究概览
简要总结
Gut bacteria constitute a vital element of the microbiota ecosystem within the human gastrointestinal tract, which is inhabited by approximately 1014 microbes—tenfold the number of human cells (Thursby E, 2017). These gut bacteria are crucial for maintaining human health, as they provide essential nutrients, synthesize vitamin K, assist in the breakdown of cellulose, and support angiogenesis and the functioning of enteric nerves. (Zhang YJ, 2015) Nevertheless, alterations in their composition can occur, leading to potential harm, particularly when the gut ecosystem experiences disruptions due to factors such as antibiotic use, illness, stress, aging, poor dietary choices, and lifestyle habits. Dysbiosis within the gut bacterial communities has been linked to various chronic conditions, including inflammatory bowel disease, obesity, cancer, and autism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female subjects between 18 to 45 years.
- •Subjects having mild to moderate Gastrointestinal symptoms like abdominal discomfort, bloating, gas, flatulence, abdominal fullness with GSRS score between 15 to
- •Subjects who have not participated in any other similar clinical study within the last 3 months of screening.
- •Subjects willing to sign informed consent and follow the study procedure.
- •5.Women of child-bearing potential using reliable method of contraception and willing to adopt the reliable and validated contraceptive methods throughout the study period to avoid pregnancy.
- •Male subjects willing to use adequate/ validated contraception and refrain from donating sperm from entering to the study until 90 days after the follow-up visit.
排除标准
- •1.Subjects with known clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, renal, congenital, immunological or any other disorder that can interfere with the study conduct and outcome in the opinion of the Investigator.
- •2.Subject has chronic health conditions that would prevent him or her from fulfilling the study requirements as judged by the investigator based on medical history and routine laboratory test results.
- •3.Subjects diagnosed with clinically significant GI disorders (Celiac, peptic ulcer, ulcerative colitis, Crohn disease, cancer).
- •4.Use of pre-and probiotics within 30 days prior to screening.
- •5.Subjects with known history or present condition of allergic response to the study drug or any ingredients in the investigational product.
- •6.Pregnant and lactating women (as assessed by UPT u history of amenorrhea).
- •7.Known alcohol or any other substance abuse.
- •8.Any other reason (physical, psychological or social) that can interfere with the subject’s compliance to the study in the opinion of the Investigator.
结局指标
主要结局
Safety and Efficacy Assessment of Gastrointestinal tolerability through GSRS (Gastrointestinal Symptoms Rating Scale).
时间窗: Day 1 & Day 7, Day 14, Day 28
次要结局
- 1.Safety evaluation through Incidence of adverse events during the study period.(2.Proportion of subjects withdrawing from study because of adverse)
研究者
Dr Rajendra Narayana Sharma
Roshni Speciality Clinic