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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational supplement | Experimental | Participants in this arm will take a supplement containing 2'-fucosyllactose (2'-FL) |
|
| Placebo supplement | Placebo Comparator | Participants in this arm will take a placebo supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a supplement containing 2'-fucosyllactose (2'-FL) | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| F. Prausnitzii abundance | F. Prausnitzii abundance will be measured in stool via 16s RNA sequencing and quantified | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| F. Prausnitzii relative abundance | F. Prausnitzii abundance will be measured in stool via 16s RNA sequencing and the proportion to other organisms calculated | 6 weeks |
| Bifidobacterium spp. relative abundance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anders Gundersen, MS | Contact | 503-552-1752 | agundersen@nunm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ryan Bradley, ND, MPH | National University of Natural Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Natural Medicine | Recruiting | Portland | Oregon | 97201 | United States |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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|
| Placebo Supplement | Dietary Supplement | 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. |
|
Bifidobacterium spp. relative abundance in stool will be measured via 16s RNA sequencing and the proportion to other organisms calculated
| 6 weeks |
| Alpha diversity of the microbiota | Alpha diversity is a measure of overall diversity of organisms within in a stool sample | 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 | 6 weeks |
| IBS-Severity Scoring System | Validated instrument that quantified patient-reported IBS severity | 6 weeks |
| IBS-Adequate Relief from Symptoms | Validated instrument that measures patient-reported relief from IBS symptoms | 6 weeks |
| Bristol Stool Form Scale | 7-point scale used qualitatively assessing form of stool | 6 weeks |
| D004066 | Digestive System Diseases |