Probiotics for Inflammation in Pediatric Chronic Pain

Medical College of Wisconsin

Status: Active, not recruiting

Conditions: Body Mass Index >=85th Percentile; Chronic Pain

Treatments: Dietary Supplement: Lactobacillus Plantarum

Study type: Interventional

Funder types: Other

Identifiers

NCT05141890

1679041

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Probiotic

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lactobacillus Plantarum