A randomized doubleblind placebocontrolled three arm parallel study to evaluate the safety of FructoSpore in healthy human volunteers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- 1. To evaluate the safety of FructoSpore in Healthy Human Volunteers
研究概览
简要总结
This is A randomized, double-blind, placebo-controlled, three-arm, parallel study to evaluate the safety of 10 Billion , 20 Billion Spores of FructoSpore in comparison with placebo in healthy human volunteers.
The study involves 31 days, i.e., from the beginning till the end of the treatment. A screening test will be conducted 5 days prior to the enrollment into the study. During the study period, the study participants must visit the study site 3 times in-person and connect with the study investigator once remotely over the phone for a telephonic discussion which will be conducted after 7 days from the date of last visit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female participants whose age 18 and 49 years and having Body Mass Index BMI 29.9 2.
- •Participants must provide a written and signed informed consent and comply with requirements of the study.
- •Must be able to swallow oral medications for 30 days on a daily basis and comply with 4.
- •Absence of any clinically significant disease or abnormal laboratory values as decided by the PI
- •Participant must consume Investigational Products only during the study.
- •He or She must refrain from consuming any prebiotic, postbiotic, vitamins, minerals & any other supplements during the study
- •Female participant of childbearing potential must use an approved method of contraception and must be willing to continue its use throughout the study duration or female participant of non-childbearing potential.
排除标准
- •Females who are planning to become pregnant in the next three months or had a positive pregnancy test at the time of screening and study period.
- •Participants with a prior history of clinically significant diseases disorders allergy.
- •Participant with any of the following shall be excluded from the study- inflammatory, autoimmune diseases, diabetes, lactose intolerance, immune deficiency, hyperthyroidism or hypothyroidism, history of GERD, gastric ulcer, and irritable bowel disease.
- •Participant with a prior history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease.
- •Allergy or Significant history of hypersensitivity or idiosyncratic reactions to any food items, medicines, investigational product or its excipients.
- •History of organ transplantation.
- •Participants had undergone any surgery during the last six months.
- •Use of any medications within 1 month before the start of the study.
- •Use of systemic corticosteroids within 1 month before the start of the study.
- •Use of prebiotics postbiotics vitamins minerals dietary or herbal supplements within 15 days before the start of the study and not willing to refrain from the use of any new vitamins and or minerals and or dietary and or herbal supplements during the study.
- •History of difficulty in swallowing food and medication.
结局指标
主要结局
1. To evaluate the safety of FructoSpore in Healthy Human Volunteers
时间窗: 1. Randomization day to Day to 31 | Safety Follow-up at the end of the study
2. Safety is determined through changes in lab test results and incidence of adverse events
时间窗: 1. Randomization day to Day to 31 | Safety Follow-up at the end of the study
次要结局
- 1. To evaluate the changes in Gastrointestinal Symptom Rating Scale and Bristol Stool Score compared to placebo.(2.o Mean change in the Bristol Stool Score)
研究者
DrMeghana Murthy
VegusSuper Speciality Hospital