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.
The subject is an adult male or female aged between 18 to 60 years old.
The subject is having refrigerator at their home for storage of test treatment.
The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.
The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.
The subject has a history of diagnosis of either hypertension, diabetes, or liver disease.
The subject has any other significant medical condition that could interfere with the study or pose a risk to the participant.
The subject has used medications that could influence the study outcomes, such as antibiotics, immunosuppressive drugs, and probiotics or prebiotics supplements within the last 4 weeks.
The subject works in frequent night shifts (working night shifts at least 3 times per week), and refuses to change the lifestyle.
Parallel
MetBroma
Other interventionMode 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
change in Albumin/Globulin ratio
Evaluate the effect of the test treatment in terms of change in Albumin/Globulin ratio
change in total serum protein
Evaluate the effect of the test treatment in terms of change in total serum protein
change in prealbumin levels
Evaluate the effect of the test treatment in terms of change in prealbumin levels.
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
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)
Performance of safety laboratory tests including Biochemical tests
Evaluate the safety of test treatment through the performance of safety laboratory tests including Biochemical tests
Performance of safety laboratory tests including Urinalysis
Evaluate the safety of test treatment through the performance of safety laboratory tests including Urinalysis
Assessment of the effectiveness of the test treatment in terms of change in CRP levels
CRP will be evaluated by Lab Parameters
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NovoBliss Research Pvt Ltd
Lead sponsor
Meteoric Biopharmaceuticals Pvt. Ltd.
Collaborator
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