30 Participants receiving Active product. for Gastrointestinal Dysfunction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atlantia Clinical Trials Ltd., Chicago, IL
Gastrointestinal Dysfunction
Active - DietarySupplement
Eligibility
18 - 65
All Sexes
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Study Summary

A randomized, double-blinded, placebo-controlled, parallel study, to evaluate the effect of 8-week supplementation of a traditionally fermented organic coconut milk kefir compared to placebo on gastrointestinal symptoms in healthy adults.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Gastrointestinal Dysfunction

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 8 weeks

8 weeks
Change in Hs-CRP
Change in daily performance (energy and mental clarity) assessed daily eDiary
Change in mean daily severity of Abdominal Discomfort symptoms of Participants (as recorded in the daily e-diary Abdominal Pain question).
Change in mean daily severity of Abdominal Pain symptoms of Participants (as recorded in the daily e-diary Abdominal Pain question).
Change in microbiome profile
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).
Change in proportion of Participants who report a change in the maximum severity of their bloating in a daily eDiary.
Change in quality of life assessed by the Short Form-36 (SF-36)
Difference between product groups of self-reported symptom improvement from the Global Impression of Change Scale at end of intervention.
Incidence of AEs by MEDRA System Organ Classification (SOC) and preferred term (PT) [Safety]
Incidence of Adverse Events (AEs) [Safety]
Incidence of Serious Adverse Events (SAEs) [Safety]
Incidence of Vital Parameter AEs [Safety]
Incidence of mild, moderate, and severe AEs [Safety]
Overall product satisfaction questionnaire as measured by the Overall Product Satisfaction Questionnaire

Trial Safety

Safety Progress

1 of 3

Other trials for Gastrointestinal Dysfunction

Trial Design

2 Treatment Groups

30 Participants receiving Active product.
1 of 2
30 Participants receiving Placebo product.
1 of 2
Active Control
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: 30 Participants receiving Active product. · Has Placebo Group · N/A

30 Participants receiving Active product.
DietarySupplement
ActiveComparator Group · 1 Intervention: Active · Intervention Types: DietarySupplement
30 Participants receiving Placebo product.
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Trial Background

Alice Eggleston PA-C, Principal Investigator
Principal Investigator
Coconut Goodness Food Products Inc.
Closest Location: Atlantia Clinical Trials Ltd. · Chicago, IL
Photo of Chicago  1Photo of Chicago  2Photo of Chicago  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Gastrointestinal Dysfunction
0 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to participate in the study and comply with its procedures, including but not limited to consuming study product, adhering to visit schedule and e-diary/questionnaires, abstaining from products outlined in Section 5.
You are 25 to 54 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.