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Probiotics for Inflammation in Pediatric Chronic Pain

Primary Purpose

Chronic Pain, Body Mass Index >=85th Percentile

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lactobacillus Plantarum

About this trial

This is an interventional other trial for Chronic Pain

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female biological sex
13-17 years of age
Body Mass Index ≥85th percentile for sex and age

Exclusion Criteria:

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

Sites / Locations

Children's Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotic

Arm 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.

Outcomes

Primary Outcome Measures

Change in systemic inflammation - CRP

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05141890

First Posted

November 17, 2021

Last Updated

August 25, 2023

Sponsor

Medical College of Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT05141890

Brief Title

Probiotics for Inflammation in Pediatric Chronic Pain

Official Title

Probiotics for Inflammation in Pediatric Chronic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 25, 2022 (Actual)

Primary Completion Date

July 31, 2023 (Actual)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Body Mass Index >=85th Percentile

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactobacillus Plantarum

Other Intervention Name(s)

Lp299v

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in systemic inflammation - CRP

Description

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

Time Frame

7-11 weeks

Secondary Outcome Measure Information:

Title

Change in Worst Pain intensity

Description

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.

Time Frame

7-11 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female biological sex 13-17 years of age Body Mass Index ≥85th percentile for sex and age Exclusion Criteria: 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

Facility Information:

Facility Name

Children's Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53185

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Probiotics for Inflammation in Pediatric Chronic Pain

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