The purpose of the study is to evaluate the efficacy of a butyrate/polyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal discomfort.
This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a butyrate/polyphenol formulation on gut health and associated symptoms in healthy individuals. Participants will be asked to complete a laboratory assessment and questionnaires. A total of up to 124 subjects (62 subjects per arm) will be enrolled for the 14-day period. Laboratory testing will include an assessment of the Gut Microbiome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
Butyrate + Polyphenol Formulation
Placebo
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States
RECRUITINGThe Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS) version
Change in the Gastrointestinal Symptom Rating Scale-IBS from baseline. The responses to the questions range from no discomfort at all to very severe discomfort which would indicate a worse outcome
Time frame: 14 days
Gut Microbiome Stool Test
Change in the Gut Microbiome (strain level, functional metrics, taxonomy abundance and composition) from baseline
Time frame: 14 days
Digestion-Associated Quality of Life Questionnaire (DQLQ)
Change in the Digestion-Associated Quality of Life Questionnaire (DQLQ) from baseline. The lower score indicates an improved outcome.
Time frame: 14 days
Visual Analogue Scale (VAS) of abdominal pain
Change in the Visual Analogue Scale (VAS) of abdominal pain from baseline. The lower the value indicates an improved outcome.
Time frame: 14 days
Bristol Stool Form Scale (BSFS)
Change in the stool form from baseline. There are 7 various stool types to choose ranging from Type 1 to Type 7. Types 3 or 4 are the preferred types.
Time frame: 14 days
Gastrointestinal -Global Assessment of Improvement Scale (Gastrointestinal-GAI)
Change in the Gastrointestinal-Global Assessment of Improvement Scale (Gastrointestinal-GAI) from baseline. The responses range from substantially worse to substantially improved would indicate an improved outcome.
Time frame: 14 days
World Health Organization Quality of Life (WHOQOL-BREF)
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Change in the World Health Organization Quality of Life (WHOQOL-BREF) from baseline. The higher score indicates a better perceived quality of life for each domain.(physical health, psychological health, social relationship, environment)
Time frame: 14 days