A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of Two Different Mixes of HMO-2FL + Humiome® Post LB Postbiotic (Postbiotic-LB) on Gastrointestinal Symptoms in Irritable Bowel Syndrome (IBS) Subjects
A randomized, placebo-controlled, double-blind clinical study to evaluate the efficacy of two different mixes of HMO-2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on Gastrointestinal Symptoms in individuals with Irritable Bowel Syndrome (IBS)
• Written and signed informed consent (will be obtained before any study-related Assessments).
• Male or female aged ≥18 - 70 years at the time of consent.
• Female individuals of childbearing potential (Females who are peri or post-menopausal, i.e., when there has been no or irregular menstruation for a minimum of 12 months prior to screening, are considered not to be of child-bearing potential.), who are not surgically sterilized, must have a negative pregnancy test at screening and be willing to practice one of the following appropriate contraceptive methods until:
‣ Sexual abstinence.
⁃ Oral contraceptives.
⁃ Trans-dermal patches or depot
⁃ injection of a progestogen drug (starting at least 4 weeks prior to product administration).
⁃ Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent.
⁃ Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration/2 weeks prior screening).
⁃ Contraceptives must be effective before the randomization visit.
• Individuals with plasma FBG (fasting blood glucose) (less than equal to 125 mg/dl).
• Individuals with Hemoglobin (Hb%) (more than equal to 10 g/dl).
• Individuals with BP (blood pressure) (less than equal to 140/100 mm Hg)
• Individuals with normal haematology as assessed by CBC (complete blood counts)
• Individuals with TSH levels in between 0.4 mIU/L to 5.0 mIU/L
• Individuals with SGOT and SGPT within 2 X the Upper normal limit (ULN) and serum
• Individuals with creatinine within 1.5 X ULN
• Rome-IV diagnostic criteria: Individuals with more than 25% of bowel movements with Bristol stool types 1, 2 or 6,7 and have had recurrent abdominal pain, on average, at least 1 day/week in the last 3 months. And the pain is associated with two or more of the following criteria:
‣ Related to defecation
⁃ Associated with a change in frequency of stool
⁃ Associated with a change in form or appearance of stool as
⁃ assessed by Bristol stool types 1,2, 6 or 7.
⁃ Individuals meeting the above criteria for the last 3 months with
⁃ symptom onset at least 6 months before diagnosis
• Individuals with Abdominal pain severity (more than equal to 6 on a 11-point scale) at screening and during placebo run-in period.
• Individuals with IBS-SSS of at least 175 points at screening.
• Individuals who are mentally stable as assessed by Perceived Stress Scale (PSS) less than equal to 26 (Low to Moderate stress).
• Individuals who understand the nature and purpose of the study including the potential risks and side effects.
• Individuals who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
• Individuals who are capable of filling the app-based digital form/diary.