Probiotics for Inflammation in Pediatric Chronic Pain

Chronic Pain Clinical Trial

Official title:

Probiotics for Inflammation in Pediatric Chronic Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05141890
• Other study ID #: 1679041
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: June 1, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Inflammation

Intervention

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

Locations

Country	Name	City	State
United States	Children's Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systemic inflammation - CRP	Change in circulating C-Reactive Protein after 8 weeks of probiotic supplement.	7-11 weeks
Secondary	Change in Worst Pain intensity	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.	7-11 weeks