Evaluate the Use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ in Adults With Chronic Pain

Recruiting at 1 trial location

Overseen By Jevaneeh Rubio

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ethos Research & Development

Must be taking: Opioids

Must not be taking: Dietary supplements

Disqualifiers: Heart disease, Kidney disease, Hepatic impairment, others

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have been on a stable dosage of prescribed opioid medication for at least 3 months before joining the study.

What safety data exists for BioPlete™ Advanced Formula?

The research does not provide specific safety data for BioPlete™ Advanced Formula, but similar products like Biosprint® (Saccharomyces cerevisiae) are generally considered safe for animals and the environment, though they may cause skin and eye irritation and respiratory sensitization. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new pain measurement test and a nutritional supplement in adults with chronic pain. The test identifies markers related to pain, and the supplement aims to improve pain by addressing nutritional issues.

Research Team

Anthony Bier, MD

Principal Investigator

Nutrasource Pharmaceutical and Nutraceutical Services

Eligibility Criteria

Inclusion Criteria

Participant is willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Participant who is 30-65 years of age (inclusive).

Participant has been diagnosed with chronic pain (verbal confirmation from participant, physician records not needed) for more than 2 years at screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either BioPlete™ Advanced Formula or placebo for 6 weeks

6 weeks

3 visits (in-person) at baseline, 3 weeks, and 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BioPlete™ Advanced Formula
• Placebo

Participant Groups

Group I: BioPlete™ Advanced Formula Experimental Treatment 1 Intervention

BioPlete™ Advanced Formula in Capsule Intervention: Dietary Supplement: Multi-Vitamin

Group II: Placebo Placebo Group 1 Intervention

Rice Flour in a capsule Intervention: Other: Placebo

Who Is Running the Clinical Trial?

Ethos Research & Development

Lead Sponsor

Trials

3

Recruited

110+

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials

40

Recruited

2,400+

Findings from Research

In a study involving healthy subjects, cellobiose was found to be safe and well-tolerated, with a maximum tolerated dose identified as 20 g for single use and 15 g twice daily for repeated consumption.

Despite some mild gastrointestinal side effects like flatulence and transient diarrhea in sensitive individuals, the overall tolerability rating was high, indicating that cellobiose could be a beneficial low-caloric bulking agent in food products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Dose-Escalation Study Demonstrates the Safety and Tolerability of Cellobiose in Healthy Subjects. Moré, MI., Postrach, E., Bothe, G., et al.[2020]

References

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

Assessment of the application for renewal of authorisation of Biosprint® (Saccharomyces cerevisiae MUCL 39885) for dairy cows and horses. [2020]

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

Assessment of the application for renewal of authorisation of Biosprint® (Saccharomyces cerevisiae MUCL 39885) for sows. [2020]

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

Safety and efficacy of a feed additive consisting of Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866 (BIO-THREE®) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, all avian species for rearing/fattening to slaughter and all avian species reared for laying or breeding to point of lay (TOA BIOPHARMA Co., Ltd.). [2022]

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

Safety and efficacy of a feed additive consisting of Saccharomyces cerevisiaeMUCL 39885 (Biosprint®) for all pigs (other than sows and weaned piglets) and other minor porcine species (Prosol S.p.A.). [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Dose-Escalation Study Demonstrates the Safety and Tolerability of Cellobiose in Healthy Subjects. [2020]