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Probiotic
Probiotics for Chronic Pain
N/A
Waitlist Available
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
13-17 years of age
Body Mass Index ≥85th percentile for sex and age
Must not have
Females who are pregnant or lactating
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-11 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a probiotic can help reduce pain in obese teens.
Who is the study for?
This trial is for young people aged 13-17 who are experiencing chronic pain, have a BMI in the 85th percentile or higher, and do not use drugs that affect gut function or inflammation. It's not for those on recent antibiotics/probiotics, with severe inflammatory diseases (except certain thyroid/asthma conditions), poor reactions to needles, pregnant/lactating females, or any condition that could interfere with the study.
What is being tested?
The trial is testing if Lactobacillus Plantarum, a type of probiotic, can help reduce inflammation and manage chronic pain in overweight adolescents. Participants will be given this probiotic to see if it has beneficial effects.
What are the potential side effects?
Probiotics like Lactobacillus Plantarum are generally considered safe but may cause digestive discomfort such as gas or bloating initially. Rarely they might lead to infection in individuals with underlying health issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 13 and 17 years old.
Select...
My BMI is in the top 15% for my age and sex.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7-11 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-11 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in systemic inflammation - CRP
Secondary study objectives
Change in Worst Pain intensity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ProbioticExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,181,663 Total Patients Enrolled
1 Trials studying Chronic Pain
1,188 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.You have had a bad reaction to getting blood drawn or getting vaccinations before.I am either biologically male or female.I regularly take medications that affect my stomach or inflammation.I am between 13 and 17 years old.I have taken probiotics, prebiotics, or antibiotics in the last month.My BMI is in the top 15% for my age and sex.I have well-controlled hypothyroidism or mild asthma not needing daily steroids.You are not allowed to use illegal drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Probiotic
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.