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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Atlantia Clinical Trials Ltd.
Chicago, Illinois, United States
Change in proportion of Participants who report a change in the maximum severity of their bloating in a daily eDiary.
To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on the severity of bloating from baseline to Week 8 (confirmed by selecting a lower category of severity of bloating during the 7-day period prior to end of intervention compared to the 7-day period prior to Baseline on the day with their worst symptom rating).
Time frame: 8 weeks
Change in mean daily severity of Abdominal Pain symptoms of Participants (as recorded in the daily e-diary Abdominal Pain question).
To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on the severity of abdominal pain (as recorded in the daily e-diary Abdominal Pain question) during the 7-day period prior Baseline compared to the 7-day period prior to end of intervention.
Time frame: 8 weeks
Change in mean daily severity of Abdominal Discomfort symptoms of Participants (as recorded in the daily e-diary Abdominal Pain question).
To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on the severity of abdominal discomfort (as recorded in the daily e-diary Abdominal Discomfort question) during the 7-day period prior Baseline compared to the 7-day period prior to end of intervention.
Time frame: 8 weeks
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).
To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on the severity of flatulence/gas (confirmed by selecting any option other than 'None' in response to the daily e-diary Flatulence/Gas question) during the 7-day period prior Baseline compared to the 7-day period prior to end of intervention.
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Time frame: 8 weeks
Difference between product groups of self-reported symptom improvement from the Global Impression of Change Scale at end of intervention.
To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on their overall perception of their bloating symptoms as reported in a product satisfaction questionnaire at week 8. Subjects rate perception of change in bloating using a visual analogue scale (VAS) rated from "There has been no change to my bloating" to "There has been a significant change to my bloating"
Time frame: 8 weeks