Probiotics for Inflammation in Pediatric Chronic Pain

Not Applicable

Active, not recruiting

• Conditions: Chronic Pain; Body Mass Index >=85th Percentile
• Interventions: Dietary Supplement: Lactobacillus Plantarum

• Registration Number: NCT05141890
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-02
• Study Start: 2022-04-25
• Primary Completion: 2024-08-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probiotic	Lactobacillus Plantarum	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.

Primary Outcome Measures

Name	Time	Method
Change in systemic inflammation - CRP	7-11 weeks	Change in circulating C-Reactive Protein after 8 weeks of probiotic supplement.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Children's Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States