An interventional study of a supplement containing 2'-fucosyllactose (2'-FL) and Placebo Supplement in IBS - Irritable Bowel Syndrome, sponsored by National University of Natural Medicine. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by National University of Natural Medicine · Not applicable, Interventional, and Treatment
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.
1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →National University of Natural Medicine is the lead sponsor of 39 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Participants in this arm will take a supplement containing 2'-fucosyllactose (2'-FL)
Dietary Supplement: a supplement containing 2'-fucosyllactose (2'-FL)
Participants in this arm will take a placebo supplement
Dietary Supplement: Placebo Supplement
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.
F. 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
Time frame: 6 weeks
Started Apr 2022 (actual). Primary completion is estimated for Dec 2023, 20 months after the start.
Of 297 non-industry interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 20 months is close to that.
Counting every sponsor, half of 345 studies reached it within 19 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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National University of Natural Medicine