The primary research question to be addressed is: Does a 2'-FL-containing dietary supplement impact stool microbiota composition in adults with IBS? The primary measure for determining potential impacts of the 2'-FL-containing dietary supplement on stool microbiota composition is stool abundance of Faecalibacterium prausnitzii, a commensal intestinal bacteria. Additional measures related to determining potential impacts of the 2'-FL-containing dietary supplement on gut microbiota composition are stool levels of additional commensal intestinal bacteria and measures of intestinal microbial diversity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Participants will be asked to take a commercially available dietary supplement containing 833 mg of 2'-FL, 220 mg of a blend of organic beet root and okra fruit, 100 mg of Collinsonia root, 37.5 mg organic rice hull concentrate, and 14 mg calcium stearate.
Participants will be asked to take a placebo supplement containing 510.9 mg organic sucanat, 385.4 mg calcium phosphate, 304.7 mg cellulose, 143.4 mg date powder, 39.4 mg rice bran powder, 9.0 mg gum arabic, and 7.2 mg calcium stearate.
National University of Natural Medicine
Portland, Oregon, United States
RECRUITINGF. Prausnitzii abundance
F. Prausnitzii abundance will be measured in stool via 16s RNA sequencing and quantified
Time frame: 6 weeks
F. Prausnitzii relative abundance
F. Prausnitzii abundance will be measured in stool via 16s RNA sequencing and the proportion to other organisms calculated
Time frame: 6 weeks
Bifidobacterium spp. relative abundance
Bifidobacterium spp. relative abundance in stool will be measured via 16s RNA sequencing and the proportion to other organisms calculated
Time frame: 6 weeks
Alpha diversity of the microbiota
Alpha diversity is a measure of overall diversity of organisms within in a stool sample
Time frame: 6 weeks
Beta diversity of the microbiota
Beta diversity is a measure of overall diversity of organisms between stool samples in the cohort of participants
Time frame: 6 weeks
IBS-Severity Scoring System
Validated instrument that quantified patient-reported IBS severity
Time frame: 6 weeks
IBS-Adequate Relief from Symptoms
Validated instrument that measures patient-reported relief from IBS symptoms
Time frame: 6 weeks
Bristol Stool Form Scale
7-point scale used qualitatively assessing form of stool
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 weeks