Probiotics for Inflammation in Pediatric Chronic Pain

NCT05141890 | Active Not Recruiting

• 1 other identifier: 1679041
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain; Body Mass Index >=85th Percentile

Outcome Measures

Primary Outcomes (1)

• Change in systemic inflammation - CRP

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

  7-11 weeks

Secondary Outcomes (1)

• Change in Worst Pain intensity

  7-11 weeks

Study Arms (1)

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.

Dietary Supplement: Lactobacillus Plantarum

Interventions

Lactobacillus Plantarum DIETARY_SUPPLEMENT

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

Also known as: Lp299v

Probiotic

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female biological sex
• years of age
• Body Mass Index ≥85th percentile for sex and age

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Wisconsin

Milwaukee, Wisconsin, 53185, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 2, 2021
• Study Start: April 25, 2022
• Primary Completion: August 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)