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Probiotic
30 Participants receiving Active product. for Gastrointestinal Dysfunction
N/A
Waitlist Available
Led By Alice Eggleston, PA-C, MPH
Research Sponsored by Coconut Goodness Food Products Inc.
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 8 weeks
Awards & highlights
Study Summary
This trial looked at whether drinking coconut milk kefir could help with gastrointestinal symptoms in adults. The study found that those who drank the coconut milk kefir had fewer symptoms than those who drank a placebo.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in proportion of Participants who report a change in the maximum severity of their bloating in a daily eDiary.
Secondary outcome measures
Change in mean daily severity of Abdominal Discomfort symptoms of Participants (as recorded in the daily e-diary Abdominal Pain question).
Abdominal Pain
Change in proportion of Participants experiencing Flatulence/Gas symptoms (selecting any option other than 'None' in response to the daily e-diary Flatulence/Gas question).
+1 moreOther outcome measures
Change in Hs-CRP
Change in daily performance (energy and mental clarity) assessed daily eDiary
Change in microbiome profile
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: 30 Participants receiving Active product.Active Control1 Intervention
Traditionally-fermented coconut milk kefir.
Group II: 30 Participants receiving Placebo product.Placebo Group1 Intervention
Solution of filtered water, Calcium Carbonate powder, and coconut extract.
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Who is running the clinical trial?
Coconut Goodness Food Products Inc.Lead Sponsor
Alice Eggleston, PA-C, MPHPrincipal InvestigatorAtlantia Clinical Trials Ltd.
1 Previous Clinical Trials
25 Total Patients Enrolled
Stacey Boetto, FNP-CPrincipal InvestigatorAtlantia Clinical Trials Ltd.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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