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

39 Participants Needed

Trial Summary

What is the purpose of this trial?

To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index \>=85th percentile.

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.

What data supports the effectiveness of the treatment Lactobacillus Plantarum for chronic pain?

Research suggests that probiotics, like Lactobacillus Plantarum, may help manage chronic pain by influencing the gut microbiome, which is linked to pain regulation. Studies have shown that probiotics can reduce pain and improve symptoms in conditions like fibromyalgia, indicating potential benefits for chronic pain management. ^{1 2 3 4 5}

Is Lactobacillus plantarum safe for human use?

Lactobacillus plantarum has been studied in humans for conditions like irritable bowel syndrome and is generally considered safe, with no serious side effects reported. In animal studies, it did not cause harmful effects in healthy or colitis-affected mice, suggesting it is safe for use. ^{6 7 8 9 10}

How does the treatment Lactobacillus Plantarum differ from other treatments for chronic pain?

Lactobacillus Plantarum is unique because it is a probiotic that can colonize the gut and potentially alter the immune response, which may help in managing chronic pain by reducing inflammation and improving gut health. Unlike traditional pain medications, it works by enhancing gut health and immune function rather than directly targeting pain pathways. ^{11 12 13 14 15}

Eligibility Criteria

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

I am not pregnant or breastfeeding.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Microbes, microglia, and pain. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Altered gut microbiota and endocannabinoid system tone in vitamin D deficiency-mediated chronic pain. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effect of prebiotic and probiotic supplementation on reduced pain in patients with fibromyalgia syndrome: a double-blind, placebo-controlled randomized clinical trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Orally Administered Bifidobacterium adolescentis Diminishes Serum Glutamate Concentration in Mice. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A role for gut microbiota in early-life stress-induced widespread muscle pain in the adult rat. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical trial: Lactobacillus plantarum 299v (DSM 9843) improves symptoms of irritable bowel syndrome. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Lactobacillus plantarum 299V in the treatment and prevention of spontaneous colitis in interleukin-10-deficient mice. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Use of mouse models to evaluate the persistence, safety, and immune modulation capacities of lactic acid bacteria. [2019]

9. Germany 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]. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2 improve quality-of-life and IBS symptoms: a double-blind, randomised, placebo-controlled study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Synergy between Lactobacillus paracasei and its bacterial products to counteract stress-induced gut permeability and sensitivity increase in rats. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Probiotic Lactobacillus rhamnosus GG (LGG) and prebiotic prevent neonatal inflammation-induced visceral hypersensitivity in adult rats. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Isolation of adhesive strains and evaluation of the colonization and immune response by Lactobacillus plantarum L2 in the rat gastrointestinal tract. [2009]

14. Brazil pubmed.ncbi.nlm.nih.gov

Probiotic features of two oral Lactobacillus isolates. [2021]

15. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of probiotic properties of Lactobacillus plantarum strains isolated from Chinese sauerkraut. [2021]