This is an open-label, two-arm, prospective, interventional, in-use safety and efficacy study of an oral probiotic supplementation in adult subjects having irritable bowel syndrome.
A total of the up to 18 adults aged between 18 and 60 years, with irritable bowel syndrome will be enrolled to ensure 16 subjects complete the study. Subjectsshall be instructed to visit the facility for the following scheduled visits: * Visit 01 \[Within 30 days\]: Screening, Blood Parameter Assessment. * Visit 02 \[Day 01\]: Enrolment, Evaluations, Treatment Dispensing. * Visit 03 \[Day 15 (±2 days)\]: Telephonic follow-up. * Visit 04 \[Day 30 (±2 days)\]: Treatment End, Final Evaluations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
18
Mode of Usage: Take one slow-release capsule twice a day, after meal Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day
NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, India
change in Albumin/Globulin ratio
Evaluate the effect of the test treatment in terms of change in Albumin/Globulin ratio
Time frame: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
change in total serum protein
Evaluate the effect of the test treatment in terms of change in total serum protein
Time frame: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
change in prealbumin levels
Evaluate the effect of the test treatment in terms of change in prealbumin levels.
Time frame: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
Change in the lifestyle using the Scoring and Gradation
Assessment of the effectiveness of the test treatment in terms of change in the lifestyle using the Scoring and Gradation. Severely disturbed lifestyle- 76%-100% Marked disturbed lifestyle-51%-75% Moderately disturbed lifestyle -25%-50% Mild disturbed lifestyle\<25
Time frame: Day 01 (before administration) for baseline, and post-dose on Day 30.
Scoring and Gradation of symptoms of irritable bowel syndrome
Evaluate of the effect of test treatment using Scoring and Gradation of symptoms of irritable bowel syndrome. Complete remission-76%-100% Marked improvement-51%-75% Mild improvement-25%-50% Unchanged\<25%
Time frame: Day 01 (before administration) for baseline, and post-dose on Day 30.
Performance of safety laboratory tests including Complete Blood Count (CBC)
Evaluate the safety of test treatment through the performance of safety laboratory tests including Complete Blood Count (CBC)
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Time frame: on Day 30
Performance of safety laboratory tests including Biochemical tests
Evaluate the safety of test treatment through the performance of safety laboratory tests including Biochemical tests
Time frame: on Day 30
Performance of safety laboratory tests including Urinalysis
Evaluate the safety of test treatment through the performance of safety laboratory tests including Urinalysis
Time frame: on Day 30
Assessment of the effectiveness of the test treatment in terms of change in CRP levels
CRP will be evaluated by Lab Parameters
Time frame: on Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).
Assessment of the effectiveness of the test treatment in terms of change in IL-6 levels
IL-6 will be evaluated by Lab Parameters
Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).