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Probiotic
Prebiotic and Probiotic Supplement for General Health
Saint Petersburg, FL
N/A
Recruiting
Research Sponsored by Olly, PBC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject agrees not to take any dietary supplements or medications throughout the clinical study
Subject is a healthy male or female between the ages of 18 - 50 years, inclusive
Must not have
Subject has severe digestive issues (e.g., IBS, Crohn's Disease, Ulcers, Severe Constipation, etc.)
Subject has used antibiotics in the last 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to end of study at 10 weeks
Summary
This trial tested a new dietary supplement in a single-center study. Participants kept a food log, provided stool samples and blood draws, and completed questionnaires. The study was randomized, double-blind, and
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Who is the study for?
This trial is for healthy individuals who are willing to take a dietary supplement or placebo, keep a daily food log, provide stool samples and blood draws, and complete certain health questionnaires.Check my eligibility
What is being tested?
The study tests the effects of a prebiotic and probiotic supplement compared to a placebo. It's designed as a randomized, crossover trial where participants will switch between treatments.See study design
What are the potential side effects?
Since this study involves healthy subjects taking prebiotics and probiotics, side effects may include digestive discomfort such as bloating or gas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to take any supplements or medications during the study.
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I am between 18 and 50 years old and healthy.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe digestive problems like IBS or Crohn's.
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I have taken antibiotics in the past 3 months.
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I have had cancer in the last 5 years.
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I have planned surgeries or medical procedures during the study.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to end of study at 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to end of study at 10 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Gastrointestinal Symptoms (GSRS) Scores
Changes in Stool Consistency (Bristol Stool Chart)
Secondary study objectives
Changes in Gut Microbiome Composition (Stool Samples)
Changes in Immune Biomarkers (Blood Samples) Levels
Other study objectives
Changes During Initial Dose Effects (24-Hour Questionnaire)
Changes in Daily Diet and Symptoms (Daily Diary)
Changes in Daily Quality of Life (DQLQ) Scores
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Dietary Supplement with activesActive Control1 Intervention
Oral dietary supplement. Instructions: Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day.
Group II: PlaceboPlacebo Group1 Intervention
Oral dietary supplement. Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day.
Find a Location
Closest Location:Princeton Consumer Research· Saint Petersburg, FL
Who is running the clinical trial?
Olly, PBCLead Sponsor
3 Previous Clinical Trials
217 Total Patients Enrolled