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Active Not Recruiting
NCT05141890
Probiotics for Inflammation in Pediatric Chronic Pain
Conditions: Chronic Pain, Body Mass Index >=85th Percentile
Sex: All
Ages: 13 Years – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 39
Sponsor: Medical College of Wisconsin
Location: Children's Wisconsin Milwaukee Wisconsin
Summary
To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index \>=85th percentile.
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
Source: ClinicalTrials.gov (NCT05141890). StuddyBuddy aggregates publicly available trial information.