Body Mass Index >=85th Percentile, Chronic Pain
Conditions
Brief summary
To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index \>=85th percentile.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus Plantarum
Dietary Supplement: Lp299v. Lp299v is a commercially available probiotic supplement manufactured and distributed by Next Foods.
Sponsors
Medical College of Wisconsin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female biological sex 2. 13-17 years of age 3. Body Mass Index ≥85th percentile for sex and age
Exclusion criteria
1. Probiotic (or prebiotic) supplement use or antibiotic use within the past month 2. 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 3. Patients who have had a poor response to blood draw or immunizations in the past 4. Chronic use of medications known to alter gastrointestinal function or inflammation (e.g. metformin, non-steroidal anti-inflammatory medications) 5. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results 6. Use of illicit drugs 7. Females who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systemic inflammation - CRP | 7-11 weeks | Change in circulating C-Reactive Protein after 8 weeks of probiotic supplement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Worst Pain intensity | 7-11 weeks | 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. |
Countries
United States
Outcome results
None listed