Probiotic Comparative Clinical Trial in patients with gas symptoms.
- Registration Number
- CTRI/2018/05/014071
- Lead Sponsor
- Sanzyme Biologics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: Visit 1 (Screening) <br/ ><br>Visit 2 (Randomization Day 0) <br/ ><br>Visit 3 (Day 15) <br/ ><br>Visit 4 (Day 30) <br/ ><br>Visit 5 (Day 37)
- Secondary Outcome Measures
Name Time Method 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.Timepoint: Visit 1 (Screening) <br/ ><br>Visit 2 (Randomization Day 0) <br/ ><br>Visit 3 (Day 15) <br/ ><br>Visit 4 (Day 30) <br/ ><br>Visit 5 (Day 37)