Overview

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)

Eligibility

• 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.

Exclusion Criteria:

• Individuals with IBS-M.
• Treatment with an investigational drug within 30 days/5 half-lives of the drug (whichever longest) prior to screening visit.
• Individuals with organic disease like infectious diseases, inflammatory diseases, metabolic disorders, neurological diseases, autoimmune disorders, cancer etc. (to be ruled out by physician based on prior history and physical examination).
• Individuals with a history of surgical resection of the stomach, small intestine or large intestine.
• Individuals with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis), colitis and enteritis.
• Individuals with a history of any diet-based intolerance (gluten or lactose intolerance).
• Individuals with a history of drug or alcohol abuse within the past 6 months.
• Individuals with severe depression or an anxiety disorder, which could potentially affect the efficacy evaluation (as determined by the qualified investigator).
• Individuals with uncontrolled hypertension or on antihypertensive medications.
• Individuals with serious cardiovascular diseases, respiratory diseases, renal diseases, hepatic diseases, gastrointestinal diseases (excluding IBS), blood diseases or neurological or psychiatric diseases.
• Individuals who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.
• Individuals with Type I or Type II diabetes mellitus.
• Individuals with a history of or current diagnosis of any cancer diagnosed less than 5 years prior to screening. Individuals with cancer in full remission more than 5 years after diagnosis are acceptable.
• Individuals who are immuno-compromised (HIV positive, on antirejection medication, rheumatoid arthritis and other autoimmune disorders).
• Individuals with a history of abdominal surgery.
• Individuals with diarrhoea of any other origin.
• Individuals currently or in future planning to fast for more than 24 hours.
• Individuals with an active eating disorder.
• Individuals who have used an over-the-counter or prescription laxative medication or any other herbal agents affecting GI motility within 2 weeks prior to screening.
• Individuals who have used pre/pro/post/synbiotic, Human Milk Oligosaccharides (HMOs), or fiber supplements (or probiotic/fiber enriched foods) or FODMAP diet or an antibiotic within 4 weeks prior to screening.
• Individuals who have used IBS specific treatments within 4 weeks prior to screening.
• Individuals who currently consume greater than 2 standard alcoholic drinks per day from past 3 months. ((One unit of alcohol is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer)
• Smokers (in any number and any format)
• Individuals with an allergy or sensitivity to the probiotic products.
• Individuals who are cognitively impaired and/or who are unable to give an informed consent.
• Individuals who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the qualified investigator, may adversely affect the Individuals' ability to complete the study or its measures or which may pose significant risk to the individual.