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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-11 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in systemic inflammation - CRP
Secondary outcome measures
Change in Worst Pain intensity
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
609 Previous Clinical Trials
1,162,562 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant capacity of this research exercise?
"Affirmative. Clinicaltrials.gov attests that this study, initially made public on April 25th 2022, is actively seeking patients. As of now they are searching for 30 people to join the trials at one site."
Answered by AI
Is it feasible for me to become involved in this research?
"This clinical trial is presently admitting 30 adolescent individuals who present with obesity. The fundamental qualifiers for enrolment are: biological sex (male or female), age range of 13-17 years, and a BMI above the 85th percentile for their respective gender and age bracket."
Answered by AI
Is this experiment restricted to those who are below a certain age?
"According to this trial's eligibility requirements, only those between the ages of 13 and 17 are allowed to participate."
Answered by AI
Are there any open slots for participation in this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this research endeavour is actively seeking participants and opened recruitment on April 25th 2022. 30 patients need to be recruited from 1 medical site before the last edit date of June 20th 2022."
Answered by AI
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