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.
Sexual abstinence.
Oral contraceptives.
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.
Parallel
MIX 1
Dietary supplementHumiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-Ofucosyllactose 300 mg 1 capsule per day Orally
MIX 2
Dietary supplementHumiome® Post LB postbiotic 100 mg Human Milk Oligosaccharides 2'-O-fucosyllactose 500 mg 1 capsule per day Orally
Placebo
Dietary supplementMicrocrystalline cellulose 1 capsule per day Orally
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS), when compared to placebo
The IBS Severity Scoring System (IBS-SSS) will be used to assess symptom severity. Participants will rate their symptoms over the last 10 days on day 0 and day 42. The change in the average IBS severity score will be calculated and compared to the placebo group.
To assess the efficacy of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on IBS symptoms as assessed by IBS Symptom Severity Scale , when compared to placebo in individuals
The IBS Severity Scoring System (IBS-SSS) will be used to assess symptom severity. Participants will rate their symptoms over the last 10 days on day 0 and day 21. The change in the average IBS severity score will be calculated and compared to the placebo group.
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on IBS symptoms as assessed by IBS-SSS, when compared to baseline in individuals with IBS
The IBS Severity Scoring System (IBS-SSS) will be used to assess symptom severity. Participants will rate their symptoms over the last 10 days on day 0 and day 42. The change in the average IBS severity score will be calculated and compared to baseline in individuals with IBS.
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on Abdominal Pain severity compared to baseline, each other and placebo in individuals with
Decrease in Abdominal pain severity as assessed by APS-NRS (Abdominal pain severity - Numeric rating scale)
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on participant by Stool consistency (Bristol Stool Form Scale types 3, 4 & 5)
In gastroenterology, stool consistency is commonly measured using the Bristol Stool Form Scale (BSFS), which categorizes stool into seven types, from type 1 (hard lumps) to type 7 (watery diarrhea). It is a simple, cost-effective tool used as a marker for intestinal transit time and bowel function. In this study, stool consistency will be assessed using the BSFS.
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on gut microbiome composition compared to baseline, each other and placebo
Improved Microbiome composition (i.e., increased in beneficial bifidobacteria) (on a selection of samples) will be analyzed using full shotgun sequencing (Illumina Hiseq 150 x2). This will be done on selection of samples
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on microbiome diversity compared to baseline, each other and placebo
Improved microbiome diversity (alpha and beta) will be analyzed (on a selection of samples) using full shotgun sequencing (Illumina Hiseq 150 x2) This will be done on selection of samples
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on fecal metabolomics profile compared to baseline, each other and placebo
Other fecal metabolites will be analysed for improvement (on a selection of samples) by an untargeted metabolomics approach using (semi-polar LC-MS/MS method. This will be done on selection of samples
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on Changes in organic acids in fecal samples compared to baseline, each other and placebo
Improvement in fecal organic acids (acetate, propionate, butyrate, valerate, lactate) as analyzed (on a selection of samples) by a targeted quantitative SCFA method (GC-MS). This will be done on selection of samples
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