This is a randomized, double-blind, placebo-controlled, parallel-group clinical study. The primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of healthy participants without any known gastrointestinal disorders from baseline to endpoint in response to the prebiotic intervention (FiberSmart). The study population are adults (n=30) who will ingest either the FiberSmart or a matched Placebo daily for 21 days. Both products will be referred to as the Investigational Product (IP) in the study procedures section. While prebiotics are widely used for gut health, their specific impact on the small intestinal ecosystem remains largely uncharacterized compared to the large intestine. Understanding their impact on the upper GI tract can lead to new insights into their mechanisms of action. Given the critical role of the small intestine in metabolism and immunity, the study utilizes the SIMBA capsule to measure novel changes in the small intestine along with traditional measurements from stool samples.
Aged 19-40 years old at the inclusion of the study, both female and male subjects.
Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit.
Willing to maintain their current lifestyle during the study.
Able to swallow a 25mm length and 9mm width sized capsule.
Use of any prescription medication within 14 days prior to the start of the study, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant (excluding oral contraceptives).
Any current acute or chronic medical condition, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant.
Known or suspected history of any gastrointestinal disease including, but not limited to, irritable bowel syndrome, celiac disease (treated or untreated), inflammatory bowel disease, persistent diarrhea, chronic constipation, gastrointestinal malignancy, or any condition known to affect gastrointestinal motility or absorption.
Less than 3 bowel movements a week
Parallel
FiberSmart
DrugAnderson Global's FiberSmart Formulation, branded as FiberSmart, which is a soluble tapioca fiber powder (resistant dextrin). Natural Product Number 80091222. The product is a prebiotic supplement intended for oral consumption.
Placebo
Other interventionPlacebo: Microcrystalline Cellulose, matches for appearance and taste, and is inert without prebiotic effects.
Primary
To evaluate changes in the small intestinal microbiome of healthy participants from baseline to the end of the 21#day FiberSmart intervention, as assessed by differential abundance testing of bacterial taxa across sampling timepoints using the SIMBA capsule. Shotgun metagenomic sequencing will be used to characterize taxonomic and functional shifts in the small intestinal microbiome.
Secondary 1
Assess the difference in metagenomic profile between the small intestine and stool within participants in response to the FiberSmart intervention from baseline, to the end of intervention using the SIMBA capsule.
Secondary 2
Assess the microbial composition (superimposability of PLS-DA mapping) of the SI from samples collected by the SIMBA capsule
Secondary 3
Explore the potential impact FiberSmart has on bowel movement frequency and texture correlation using daily questionnaires
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