Randomized controlled clinical study has been proposed to evaluate the safety and efficacy of ES1 probiotic strain and heat-treated ES1 postbiotic strain in individuals suffering from IBS-D.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
200
Apex Gastro Clinic and Hospital
Ahmedabad, Gujarat, India
Gastroplus, Digestive disease centre
Ahmedabad, Gujarat, India
Aman Hospital and research centre
Vadodara, Gujarat, India
Shantaee Nursing Home
Mumbai, Maharashtra, India
Irritable Bowel Syndrome-Symptom Severity Scale
To determine the efficacy of investigational products on the participants global assessment of gastrointestinal symptoms, as assessed by change in Irritable Bowel Syndrome-Symptom Severity Scale total score at the end of study from baseline compared to placebo. Each of these 5 items is scored on a visual analogue scale from 0 to 100. Therefore, the total score on the ranges from 0 to 500. Participants are asked to respond to each question on a 100-point visual analogue scale. The higher the scores, the more will be the severity of symptoms. Participants, if required, can be categorized as having mild (75-175), moderate (175-300), Higher the score is the worst outcome and lower the score is the betterment.
Time frame: day 0, 28, 56, and 84
Bristol Stool Form Scale
At the end of days 28, 56, and 84, the percentage of participants transitioning to normal stool consistency (as demonstrated by weekly BSFS score reported as 3, 4, or 5) compared to baseline scores will be identified to evaluate the efficacy of IP in comparison to placebo.
Time frame: day 0, 28, 56, and 84
Irritable Bowel Syndrome-Quality of Life
Quality of life as assessed by change in Irritable Bowel Syndrome-Quality of Life. It is a 34-item questionnaire with each item rated on a 5-point scale (34-170), with increasing scores indicating the deteriorating quality of life (Appendix-III). However, to facilitate comparisons among various measures on a standardized scale, the summed scores will be transformed to a 0 - 100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).
Time frame: day 0, 28, 56, and 84
Abdominal Pain Severity-Numeric Rating Scale score.
Abdominal pain severity as assessed by change in Abdominal Pain Severity-Numeric Rating Scale (APS-NRS) score. score ratings include 0 - None, 1 to 3 - Mild, 4 to 6 - Moderate, 7 to 9 - Severe, and 10 = very severe.4
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Dr. Sanjeev Khanna clinic
Mumbai, Maharashtra, India
Stress test clinic
Mumbai, Maharashtra, India
Jaipur National University Institute for Medical Science & Research Centre
Jaipur, Rajasthan, India
Dr. Sudhir Maharshi clinic
Jaipur, Rajasthan, India
Time frame: day 0, 28, 56, and 84
State-Trait Anxiety Inventory-Adults score.
Mental health as assessed by change in State-Trait Anxiety Inventory-Adults (STAI-AD) score. The State-Trait Anxiety Inventory has 40 items, 20 allocated to each S-Anxiety and T-Anxiety sub-scales . The range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale
Time frame: day 0, 28, 56, and 84
Vitals - blood pressure
To evaluate the safety of IP consumption . Normal BP ranging Systolic120 - 129 mmHg and or diastolic 80 - 84 mm Hg
Time frame: day 0, 28, 56, and 84
Gut microbiome as assessed by 16S rRNA sequencing of faecal samples.
Time frame: day 0 and 84
Vitals - Pulse Rate
Normal Pulse rate 60 - 100 bpm
Time frame: day 0, 28, 56, and 84