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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be between 18-60 years inclusive
Be between 18 and 65 years old
Must not have
Participant who is on anxiolytics, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medication at the time of screening
Participant who is pregnant or wishes to become pregnant during the study or who is lactating and/or currently breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 8
Summary
"This trial aims to study the effects of two prebiotics on gut health and quality of life. Prebiotics are substances that are not fully digested in the upper gastrointestinal tract but instead reach the
Who is the study for?
This trial is for adults experiencing dysbiosis, which means their gut bacteria are out of balance. Participants should be interested in improving their quality of life through dietary changes. Specific eligibility criteria were not provided, so generally healthy adults looking to participate in nutritional studies may consider enrolling.
What is being tested?
The study tests the effects of two prebiotic combinations on gut health and overall well-being at different doses. One group will receive a placebo with no active ingredients, while the other will get the actual treatment to see if it positively alters gut microbiota and improves life quality.
What are the potential side effects?
Prebiotics are typically safe but can cause digestive side effects like gas, bloating, or discomfort as your body adjusts to increased fiber intake. These side effects usually lessen over time as your gut adapts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication for anxiety, psychosis, seizures, brain-related issues, pain, or sleep.
Select...
I am not pregnant, trying to get pregnant, or breastfeeding during the study.
Select...
I haven't changed my medications, supplements, or diet significantly in the last 90 days and don't plan to during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the effect of eight weeks consumption of two distinct Prebiotic supplements compared to respective Placebos on microbiota composition at the end of 8 week intervention
Secondary study objectives
To evaluate the effect of consumption of Prebiotic supplements compared to respective Placebos on Quality of Life at Week 4
To evaluate the effect of consumption of Prebiotic supplements compared to respective Placebos on Quality of Life at Week 8
To evaluate the effect of consumption of two distinct Prebiotic supplements compared to respective Placebos on microbiota composition at Week 4
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Prebiotic 2Experimental Treatment1 Intervention
Group II: Prebiotic 1Experimental Treatment1 Intervention
Group III: Placebo 2Placebo Group1 Intervention
Group IV: Placebo 1Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment
2013
Completed Phase 2
~10240
Find a Location
Who is running the clinical trial?
Atlantia Food Clinical Trials Ltd.UNKNOWN
2 Previous Clinical Trials
129 Total Patients Enrolled
Pharmavite LLCLead Sponsor
10 Previous Clinical Trials
26,734 Total Patients Enrolled
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