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Probiotic for Gut Microbiome (ProCar Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by McGill University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week -2, 0, 5, and 10

Awards & highlights

ProCar Trial Summary

This trial is testing whether probiotic supplementation can improve carotenoid status (i.e., increase absorption and bioavailability) and related changes in blood and skin in pre-menopausal women.

Eligible Conditions

Gut Microbiome
Skin Health
Carotenoid Status

ProCar Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week -2, 0, 5, and 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week -2, 0, 5, and 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and week -2, 0, 5, and 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in skin yellow color saturation measured by a spectrophotometer

Secondary outcome measures

Changes in Vitamin A status

Changes in blood plasma carotenoid status

Changes in facial skin wrinkling

+20 more

ProCar Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Carotenoid + ProbioticExperimental Treatment2 Interventions

Carotenoid: 1 capsule daily of a mixed carotenoid (~ 20 mg total carotenoids) supplement Probiotic: 1 capsule daily containing 10 x 10^9 CFU of a proprietary strain Total duration: 10 weeks

Group II: Carotenoid + PlaceboPlacebo Group2 Interventions

Carotenoid: 1 capsule daily of a mixed carotenoid (~ 20 mg total carotenoids) supplement Placebo: 1 capsule daily containing the same carrier material of the probiotic, that is also similar in size, shape, and taste. Total duration: 10 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probiotic

2013

Completed Phase 4

~3570

Carotenoid supplement

2021

Completed Phase 2

~40

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

McGill UniversityLead Sponsor

392 Previous Clinical Trials

984,468 Total Patients Enrolled

Lallemand Health SolutionsIndustry Sponsor

39 Previous Clinical Trials

3,682 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How do I sign up for this opportunity to test a new treatment?

"This study is seeking 50 individuals that have gut microbiomes and are between 30-50 years old. Other requirements for participants include: being able to document visible wrinkles on the face, a willingness to maintain current physical activity and dietary habits, discontinuing probiotic supplements and food consumption upon screening, having access to a smartphone with camera capabilities and iOS 11.0 or Android 4.2 , being healthy non-menopausal or non-perimenopausal women, having a BMI of 18.5 - 29.9 kg/m2 , and finally agreeing to refrain from taking natural health products containing carotenoids ."

Answered by AI

Do you have an age limit for participants in this research?

"The age criteria for this study stipulate that individuals must be over 30 but under 50 years old."

Answered by AI

Are there any documented risks associated with taking Probiotic?

"While there is some data suggesting probiotics are safe, efficacy has not been demonstrated in any clinical trials. Our team gives it a 2."

Answered by AI

Can more people enroll in this trial?

"The clinical trial in question is not currently searching for patients, as seen on clinicaltrials.gov. This particular study was first posted on November 1st, 2021 and was last updated on October 19th, 2022; however, 14 other trials are still enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women

2021. "Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04511052.