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To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index >=85th percentile.
The purpose of the current study: (1) examine whether a 7-11 week supplement of a single-strain probiotic (Lactobascillus Plantarum, Lp299v) reduces systemic inflammation; (2) determine whether reductions in systemic inflammation will correlate with reductions in pain, disability, mood impairment and changes in mechanical pain threshold and mechanical pain sensitization; (3) Explore whether reductions in systemic inflammation will correlate with reductions in other outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Participants will be given the probiotic supplement Lp299v. The supplement is taken by mouth in the form of capsules. Participants will undergo a screening visit. After 7-11 weeks of taking Lp299v, they will return for their final visit. Blood will be drawn before and after the 7- 11 week intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus Plantarum | Dietary Supplement | Dietary Supplement: Lp299v. Lp299v is a commercially available probiotic supplement manufactured and distributed by Next Foods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in systemic inflammation - CRP | Change in circulating C-Reactive Protein after 8 weeks of probiotic supplement. | 7-11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Worst Pain intensity | Change in worst pain intensity (based on a 0-10 numeric rating scale) over the past 2 weeks after 7-11 weeks of probiotic supplement. | 7-11 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Wisconsin | Milwaukee | Wisconsin | 53185 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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