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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Comparison of efficacy of two probiotic formulations with placebo using GI symptoms rating score (Pain score and Discomfort score),the scores of the Pain Intensity, Non-Pain Symptoms and Satisfaction with Dyspepsia related will be assessed using SODA Scale. Pain Intensity scores and non-Pain Symptoms will be assessed using VAS scale and Overall Quality of Life by SF 36 questionnaire.
研究概览
简要总结
| Study Title |
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.
|Study Rationale
The study is designed to study two formulations of probiotics on gastro intestinal gas symptoms.
|Investigational Product
1) Formulation of Bacillus coagulans manufactured by Sanzyme Biologics
Arm 1: SNZ-1969 [Each capsule contains NLT 2 Billion CFU of Bacillus coagulans].
2) Formulation of a probiotic
Arm 2: SNZ-TRIBAC [Each capsule contains NLT 2 Billion CFU of Bacillus coagulans (SNZ-1969), Bacillus clausii (SNZ-1971), Bacillus subtilis (SNZ-1972)].
3) Placebo
Arm 3: Placebo capsule of Calcium carbonate.
One capsule of investigational probiotic formulations or placebo will be self-administered by the subject once daily (OD) after a major meal at roughly the same time of the day for a period of 30 days.
|Study Objective(s)
Primary Objective
Efficacy- To compare the efficacy of two probiotic formulations with placebo as therapy in subject with complaints of abdominal distress symptoms, in the absence of specific pathologies.
Secondary Objective
**Safety-**The secondary objective of the study is to identify and evaluate adverse events occurring during the use of the formulations, and compare the same with the use of placebo.
|Approximate Duration of Study
The entire study duration will be approximately 12 months. This includes the enrollment period.
|Sample size
It was determined that 25 analyzable subjects per treatment arm would provide 80% power to obtain a significant result for a 0.8- sigma effect size. A 15% drop out rate was considered possible based on experience at the chosen sites and hence a total of 30 subjects were recruited in each group. An alpha level of 0.05 was assumed (p ≤ 0.05 considered significant).
|Study Design
The subject will be given a detailed description of the nature and purpose of the study. Only that subjects who are willing to participate in the study and have signed the Informed consent would be considered for the trial.
At screening visit/visit 1 (-7 days), Informed consent will be obtained from the subject. Thereafter, the subject will be evaluated for demographics, medical history, prior medication, physical examination, vital signs, height, body weight, haemogram, liver function tests (ALT, AST and total bilirubin), renal function tests (BUN, Sr. Creatinine) GSRS, SODA Scale, VAS Scale and QoL questionnaire (QoLSF-36 v2). Eligible subject will be requested to visit site on visit 2.
On visit 2/ randomization visit (Day 0±2 Days), subject will be randomized on the basis of their OPD (or PRN) using a fixed randomization table. IP will be dispensed to the subject. One capsule of investigational probiotic formulations or placebo will be self-administered by the subject once daily after a major meal at roughly the same time of the day for a period of 30 days
On visit 3 (Day 15****±2 Days), subject will visit site and evaluated for GSRS, SODA Scale, VAS scale and QoL questionnaire.
On visit 4 (Day 30±2 Days), subject will visit site and evaluated for GSRS, SODA Scale, VAS scale and QoL questionnaire
Follow up visit/visit 5/ EOS (Day 37±2 Days) subject will visit site and evaluated for haemogram, liver function tests (ALT, AST and total bilirubin), renal function tests (BUN, Sr Creatinine) GSRS, SODA Scale, VAS scale and QoL questionnaire.
|Statistical/Data Analysis
Statistical analyses will be performed using statistical software (SPSS/SAS). The change in severity of assessment will be compared intragroup using a paired student t-test and intergroup using ANOVA.
|Ethical Issues
The study will commence only after a written approval is obtained from ethics committee. Informed consent will be signed by patients with abdominal distress. The trial will be conducted as per the [Schedule Y of CDSCO (Central Drug Standards Control Organization), Ministry of Health and Family Welfare, Government of India], [Ethical guidelines for biomedical research on human participant, ICMR (Indian Council of Medical Research (2017)],
[ICH (International Conference on Harmonization) E6 (R2) “Guideline for Good Clinical Practiceâ€], Declaration of Helsinki (Ethical principles for Medical Research involving Human subjects, revised by WMA General Assembly, Fortaleza, Brazil October 2013) and JCDC’s standard operating procedures.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria: To be eligible for this trial, subjects must fulfill all inclusion criteria listed below:
- •Subjects of either gender between 18 to 60 years of age.(Both inclusive)
- •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.
- •Subjects willing to provide informed consent.
- •Willingness and ability to comply with protocol and protocol scheduled visits.
- •Healthy as determined by physical examination, medical history, hematological and hepatic function tests.
- •Agrees to maintain dietary and exercise habits for the duration of the trial.
- •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:
- •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.
- •Subjects using GI medications to control the function of the gut, such as anti-spasmodics, motility agents, pro-kinetic agents, or laxatives.
- •Subjects suffering from any other disorder that is likely to be the cause of abdominal symptoms
- •Subjects suffering from any disorder that is likely to interfere with their participation in the trial.
- •Subjects with psychological disorders, or using drugs or alcohol that might interfere with their compliance to trial requirements.
- •Participation in another investigational study within 30 days of the current study
- •Known hypersensitivity to any of the components of Investigational study treatments
- •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)
- •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.
- •Women who are pregnant, breastfeeding or planning to become pregnant during the duration of the trial.
- •Patients who have undergone abdominal surgery within the past 6 months.
结局指标
主要结局
Comparison of efficacy of two probiotic formulations with placebo using GI symptoms rating score (Pain score and Discomfort score),the scores of the Pain Intensity, Non-Pain Symptoms and Satisfaction with Dyspepsia related will be assessed using SODA Scale. Pain Intensity scores and non-Pain Symptoms will be assessed using VAS scale and Overall Quality of Life by SF 36 questionnaire.
时间窗: Visit 1 (Screening) | Visit 2 (Randomization Day 0) | Visit 3 (Day 15) | Visit 4 (Day 30) | Visit 5 (Day 37)
次要结局
- Identification and evaluation of adverse events occurring during the use of the formulations, and compare the same with the use of placebo throughout the study duration.(Visit 1 (Screening))