Chronic PainNCT05141890
Probiotics for Inflammation in Pediatric Chronic Pain
A study testing Lactobacillus Plantarum in people with Chronic Pain and Body Mass Index >=85th Percentile, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index >=85th percentile. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Chronic Pain, Body Mass Index >=85th Percentile
- What is being tested?
- Lactobacillus Plantarum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female biological sex
- 13-17 years of age
- Body Mass Index ≥85th percentile for sex and age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index >=85th percentile.
Read the 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.
- Conditions
- Chronic Pain, Body Mass Index >=85th Percentile
- Being tested
- Lactobacillus Plantarum
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus PlantarumDietary supplement
Also called Lp299v
Dietary Supplement: Lp299v. Lp299v is a commercially available probiotic supplement manufactured and distributed by Next Foods.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 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. Receives: Dietary Supplement: Lactobacillus Plantarum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systemic inflammation - CRP
Change in circulating C-Reactive Protein after 8 weeks of probiotic supplement.
Measured: 7-11 weeks
Secondary outcomes (1)
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.
Measured: 7-11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start25 Apr 2022
- Primary completion1 Aug 2024
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keri Hainsworth, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141890
- Sponsor's protocol ID
- 1679041
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2021
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Inflammation in Pediatric Chronic Pain
- ClinicalTrials.gov ID
- NCT05141890
- Acronym / sponsor ID
- 1679041
- Conditions
- Chronic Pain, Body Mass Index >=85th Percentile
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Lactobacillus PlantarumParticipants 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female biological sex
- 13-17 years of age
- Body Mass Index ≥85th percentile for sex and age
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus PlantarumAlso: Lp299vDietary Supplement: Lp299v. Lp299v is a commercially available probiotic supplement manufactured and distributed by Next Foods. | Dietary supplement | Probiotic |
Primary outcome
Change in systemic inflammation - CRP
Time frame: 7-11 weeks
Change in circulating C-Reactive Protein after 8 weeks of probiotic supplement.
1 secondary outcome
Change in Worst Pain intensity
Time frame: 7-11 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus Plantarum in people with Chronic Pain and Body Mass Index >=85th Percentile, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systemic inflammation - CRP (time frame: 7-11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.