Probiotics for Inflammation in Pediatric Chronic Pain

Study Overview
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Brief Summary
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To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index >=85th percentile.

Detailed Description
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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.

Official Title
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Probiotics for Inflammation in Pediatric Chronic Pain

Conditions
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Chronic Pain, Body Mass Index >=85th Percentile

Intervention / Treatment
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* Dietary Supplement: Lactobacillus Plantarum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female biological sex 13-17 years of age Body Mass Index ≥85th percentile for sex and age Exclusion Criteria: Probiotic (or prebiotic) supplement use or antibiotic use within the past month Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids Patients who have had a poor response to blood draw or immunizations in the past Chronic use of medications known to alter gastrointestinal function or inflammation (e.g. metformin, non-steroidal anti-inflammatory medications) Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results Use of illicit drugs Females who are pregnant or lactating

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>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. | Dietary Supplement: Lactobacillus Plantarum<br>* Dietary Supplement: Lp299v. Lp299v is a commercially available probiotic supplement manufactured and distributed by Next Foods.<br>* Other names: Lp299v;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systemic inflammation - CRP | Change in circulating C-Reactive Protein after 8 weeks of probiotic supplement. | 7-11 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |