Evaluating the Safety and Efficacy of the Probiotic Bifidobacterium Longum ES1 and the Post Biotic Heat-treated Bifidobacterium Longum ES1 (HT-ES1) on IBS Symptom Severity in Patients With Diarrhoea Predominant Irritable Bowel Syndrome

Exclusion Criteria

• •1. Participants diagnosed with anxiety as assessed by STAI-AD S- anxiety subscale score ≥ 40.
• •2. Gluten and/or lactose intolerant individuals.
• •3. Abnormal Thyroid Stimulating Hormone (TSH) value which is (\< 0.4 to \> 4.2 mIU/L).
• •4. Participants with uncontrolled type II diabetes mellitus defined as random blood glucose (RBG) \> 199 mg/dL or fasting blood glucose (FBG) \>125 mg/dL.
• •5. Participants with a body mass index (BMI) ≥ 30 kg/m2.
• •6. Presence of uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg.
• •7. Participants with a history of intake of antibiotics (Rifaximin, metronidazole, or any other), other probiotics, prebiotics, synbiotic, proton pump inhibitors, acid sequestrants (cholestyramine, Bile colestipol), FODMAP diet, and histamine H2- receptor antagonists/H2 blockers within six weeks prior to the screening day.
• •8. Participants with a history of daily intake of antidepressants (Tricyclic antidepressants, Selective serotonin reuptake inhibitors (SSRIs), and Selective serotonin-norepinephrine reuptake Inhibitors (SSNRIs)), clonidine, otilonium bromide, asimadoline, eluxadoline, diphenoxylate, antispasmodics including mebeverine and pinnaverium and anticholinergics within two weeks before the screening day.
• •9. Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.
• •10. Participants showing signs of bile acid malabsorption (BAM), as evident from the history of green colour or foul odour of the stool during the last month.
• •11. Participants with a history of or complications from malignant tumours.
• •12. Participation in other clinical trials in the last 90 days prior to screening
• •13. Active smokers or using any form of smokeless tobacco.
• •14. Participants with substance abuse problems (within two years) defined as:
• •15. Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
• •16. High-risk drinking as defined by the consumption of four or more alcohol-containing beverages on any day or eight or more alcohol- containing beverages per week for women and five or more alcohol-containing beverages on any day or 15 or more alcohol- containing beverages per week for men.
• •17. Participants having clinically significant illnesses of cardiovascular, endocrine, immune, respiratory, hepato-biliary, kidney and urinary, haematological, musculoskeletal system and/or any inflammatory disorder, tumour, and other gastrointestinal diseases.