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Active, Not Recruiting

NCT Number: NCT05141890

Probiotics for Inflammation in Pediatric Chronic Pain

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Pain Body Mass Index >=85th Percentile Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Wisconsin

Milwaukee, Wisconsin, 53185, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus plantarum

Dietary Supplement

Dietary Supplement: Lp299v. Lp299v is a commercially available probiotic supplement manufactured and distributed by Next Foods.

Other names: Lp299v

Primary outcomes

  1. Change in systemic inflammation - CRP

    Time frame: 7-11 weeks

    Change in circulating C-Reactive Protein after 8 weeks of probiotic supplement.

Secondary outcomes

  1. Change in Worst Pain intensity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Dec 2, 2021
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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