A prospective, open-label, single-arm, proof of science, clinical safety and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heart burn, bloating, constipation, and gut immunity).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of the test product in terms of:
研究概览
简要总结
A prospective, open-label, single-arm, proof of science, clinical safety, and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heartburn, bloating, constipation, gut immunity). Maximum 14 subjects will be enrolled and 12 subjects will complete the study. Duration will be of approximately 3 months which includes 3 visits.
Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation,
Visit 02 (Day 45): Treatment usage period, Evaluations,
Visit 03 (Day 90 ): Treatment usage period, Evaluations and End of Study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18 to 65 years (both inclusive) at the time of consent.
- •Sex: Healthy males and healthy non-pregnant/non-lactating females.
- •Females of childbearing potential must have a self-reported negative pregnancy test.
- •Subject should have refrigerator at their home for storage of test product.
- •Subjects having history of falling sick frequently in two months.
- •Subjects having elevated levels of CRP and IL-6 with symptoms of gut dysbiosis.
- •Subjects having gut dysbiosis with either of these three symptoms which includes burning sensation, bloating, nausea, altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea etc.
- •If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
- •Subjects are willing to give written informed consent and are willing to come for regular follow-up.
- •Subjects who commit not to use other probiotics, symbiotic, prebiotics, medicated treatments or food having high probiotics other than the test product for the entire duration of the study.
- •Subject who has not participated in a similar investigation in the past three months.
排除标准
- •1 Subject with suspected or proved organic causes of constipation, such as Hirschsprung disease, hypothyroidism, or structural anomalies of the anal canal.
- •2 Subject with present condition of allergic response to any probiotic product.
- •3 Subject under chronic medication aspirin based products, anti inflammatories, anti histamines, corticotherapy that might influence the outcome of the study.
- •4 Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems.
- •5 History of alcohol or drug addiction.
- •6 Subjects with a history of major gastrointestinal complications such as Crohn disease, ulcer, cancer, ulcerative colitis.
- •7 Subjects who have self reported immuno compromised HIV positive, on anti rejection medication, rheumatoid arthritis.
- •8 Pregnant or breastfeeding or planning to become pregnant during the study period.
- •9 Subjects participating in other similar product or therapeutic trials within the last four weeks.
结局指标
主要结局
To evaluate the effectiveness of the test product in terms of:
时间窗: 1.On baseline Day 1, and after usage of the test product on Day 45 and on Day 90 evaluated by the physician. | 2.On Day 1, and on Day 90. | 3.On Day 1, Day 45 and on Day 90.
1.Change in stool consistency based on the Bristol Stool Criteria.
时间窗: 1.On baseline Day 1, and after usage of the test product on Day 45 and on Day 90 evaluated by the physician. | 2.On Day 1, and on Day 90. | 3.On Day 1, Day 45 and on Day 90.
2.Change in faecal microbiota using 16s Metagenome sequencing.
时间窗: 1.On baseline Day 1, and after usage of the test product on Day 45 and on Day 90 evaluated by the physician. | 2.On Day 1, and on Day 90. | 3.On Day 1, Day 45 and on Day 90.
16s Metagenome sequencing from baseline and after usage of the test product
时间窗: 1.On baseline Day 1, and after usage of the test product on Day 45 and on Day 90 evaluated by the physician. | 2.On Day 1, and on Day 90. | 3.On Day 1, Day 45 and on Day 90.
3. Frequency of sensation of defecation, bloating, nausea, altered bowel habit, digestion issues, aching joints, chronic fatigue, constipation, diarrhoea.
时间窗: 1.On baseline Day 1, and after usage of the test product on Day 45 and on Day 90 evaluated by the physician. | 2.On Day 1, and on Day 90. | 3.On Day 1, Day 45 and on Day 90.
次要结局
- 1.To assess the effectiveness of the test product in terms of change in Biomarkers such as CRP and IL-6 from baseline and after usage of the test product.(After usage of test products on Day 01 and on Day 90.)
- To assess the effectiveness of the test product in terms of subject perception questionnaire from baseline before and after usage of the test product.(Before usage of test product on Day 01 and after usage of test product on Day 45 and Day 90.)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited