Probiotics for Inflammation in Pediatric Chronic Pain

NCT ID: NCT05141890

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2026-06-01

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.

Conditions

Chronic Pain; Body Mass Index >=85th Percentile

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Probiotic

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.

Group Type: EXPERIMENTAL

Lactobacillus Plantarum

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Lactobacillus Plantarum

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Lp299v

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Keri Hainsworth

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

1679041

Identifier Type: -

Identifier Source: org_study_id