Probiotics for Chronic Pain

Overseen By Brynn LiaBraaten, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must not be taking: Probiotics, Antibiotics, NSAIDs, Metformin

Disqualifiers: Chronic inflammatory, Autoimmune, Illicit drugs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 7-11 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the probiotic Lactobacillus Plantarum can help teens with chronic pain who have a higher body weight. The goal is to determine if this supplement provides relief from ongoing pain. Participants will take probiotic capsules for 7 to 11 weeks, with blood samples collected before and after the trial. Teens aged 13-17 with a body weight in the top 15% for their age may qualify to join. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new pain relief options for teens.

Do I need to stop my current medications to join the trial?

The trial requires that you do not use probiotics, prebiotics, antibiotics, or certain medications that affect gut function or inflammation, like metformin or non-steroidal anti-inflammatory drugs, for at least a month before joining. If you're on these, you may need to stop them to participate.

Is there any evidence suggesting that Lactobacillus Plantarum is likely to be safe for humans?

A previous study found Lactobacillus plantarum 299v safe for oral use, even over extended periods. Research shows that people have safely used it with other probiotics for up to nine months. Some individuals might experience minor side effects like gas, but serious issues are rare. This probiotic has also been safely added to foods, indicating it is generally well-tolerated. However, it may not be suitable for individuals with weakened immune systems or certain health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for chronic pain, which often involve medications like opioids or NSAIDs that can have significant side effects, the probiotic Lactobacillus Plantarum (specifically the strain Lp299v) offers a natural alternative. Researchers are excited about this treatment because it harnesses beneficial bacteria to potentially reduce pain by improving gut health and reducing inflammation. This approach not only targets pain differently but also minimizes the risk of side effects associated with long-term use of traditional pain medications.

What evidence suggests that Lactobacillus Plantarum might be an effective treatment for chronic pain?

Research has shown that Lactobacillus plantarum, a type of helpful bacteria, can reduce pain. Studies have found it eases stomach pain and bloating. Evidence also indicates it can lessen nerve pain, which arises from damaged nerves. This probiotic appears to work by balancing gut bacteria, linked to pain relief. In this trial, participants will receive Lactobacillus plantarum as the probiotic supplement Lp299v. These findings suggest Lactobacillus plantarum may be a promising option for managing long-term pain. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am either biologically male or female.

I am between 13 and 17 years old.

My BMI is in the top 15% for my age and sex.

Exclusion Criteria

You have had a bad reaction to getting blood drawn or getting vaccinations before.

I am not pregnant or breastfeeding.

Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit (in-person)

Treatment

Participants receive a single-strain probiotic (Lactobascillus Plantarum, Lp299v) for 7-11 weeks

7-11 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lactobacillus Plantarum

Trial Overview

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.

How Is the Trial Designed?

Group I: Probiotic Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Two Lactobacillus plantarum strains, S2-5 and S4-1, showed strong probiotic properties, including survival in acidic conditions, tolerance to digestive enzymes, and antimicrobial activity against harmful bacteria.

In an in vivo study, the strain S4-1 significantly reduced serum cholesterol levels in mice when fed fermented milk, highlighting its potential as a beneficial probiotic for cholesterol management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of probiotic properties of Lactobacillus plantarum strains isolated from Chinese sauerkraut. Yu, Z., Zhang, X., Li, S., et al.[2021]

In a non-interventional study involving 221 patients with IBS over 12 weeks, the probiotic Lactobacillus plantarum 299v (LP299V) significantly reduced overall IBS symptoms, including abdominal pain and flatulence, with a notable improvement in quality of life.

94% of patients reported good tolerability of LP299V, suggesting that long-term use of this probiotic is safe and effective for managing IBS symptoms in everyday conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of IBS with Lactobacillus plantarum 299v: Therapeutic success increases with length of treatment - real-life data of a non-interventional study in Germany]. Krammer, H., Storr, M., Madisch, A., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3419998/

Clinical trial: Lactobacillus plantarum 299v (DSM 9843) ...

CONCLUSION: A 4-wk treatment with L. plantarum 299v (DSM 9843) provided effective symptom relief, particularly of abdominal pain and bloating, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10415969/

Efficacy and dose response of Lactiplantibacillus plantarum in ...

A reduction in sub-scores related to abdominal pain, abdominal distension, bowel habits, and quality of life was observed in both L. plantarum groups compared ...

3.

link.springer.com

link.springer.com/article/10.1007/s12602-024-10287-3

The Health Benefits of Probiotic Lactiplantibacillus plantarum

This systematic review demonstrated that probiotic supplementation with L. plantarum, either alone or in combination, can significantly improve outcomes for ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S258953702100434X

Strain-specific and outcome-specific efficacy of probiotics ...

Four probiotics demonstrated significant reduction in abdominal pain relief: B. coagulans MTCC5260, L. plantarum 299v, S. boulardii CNCMI-745 and S. cerevisiae ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S075333222400653X

Lactobacillus Plantarum intake mitigates neuropathic pain ...

L. plantarum administration effectively reduced neuropathic pain behavior and the Firmicutes to Bacteroidetes ratio after CCI. Moreover, L. plantarum treatment ...

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fda.gov

fda.gov/files/food/published/GRAS-Notice-000685---Lactobacillus-plantarum-strain-299v.pdf

GRAS Notice 685, Lactobacillus plantarum strain 299v

All ofthese factors lead to the reasonable conclusion that most LAB strains are safe for use in conventional foods that may be consumed by all ...

7.

webmd.com

webmd.com/vitamins/ai/ingredientmono-1672/lactiplantibacillus-plantarum

Lactiplantibacillus Plantarum - Uses, Side Effects, and More

When taken by mouth: Live L. plantarum is likely safe. It's been used safely together with other probiotics for up to 9 months. Some people might experience gas ...

8.

downloads.regulations.gov

downloads.regulations.gov/FDA-2021-S-0023-0034/content.pdf

L. plantarum APsulloc 331261 1

cfu L. plantarum APsulloc 331261 in adults. In particular, the data support the safety of L. plantarum APsulloc 331261 at daily doses up to ...

9.

fda.gov

fda.gov/media/178866/download

GRAS Notice (GRN) 1127, Lactiplantibacillus plantarum ...

It is not intended to be used by certain individuals under medical supervision, including immune- compromised individuals, infants with marked ...