The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms
This is a double-blind, randomized, placebo-controlled, remote design study to evaluate the effects of a Butyrate formulation and Butyrate + Polyphenol formulation on gut health, intestinal permeability and associated symptoms. Participants will be asked to complete laboratory assessments and questionnaires. A total of up to 105 subjects (35 subjects per arm) will be enrolled in a randomly assigned sequence for the 28-day period. There will be scheduled remote video calls during the study. The study subjects will complete assessment tools that include a Rating Scale for Gastrointestinal Symptoms, Quality of Life Questionnaire for Digestion, Visual Analogue Scale of Abdominal Pain, Stool Form Scale, Global Assessment of Improvement Scale-Gastrointestinal and the Short Form-36 Health Survey (SF-36). Laboratory testing will include an assessment of Gut Microbiome, analysis of Short Chain Fatty Acids, a panel for the Gut Barrier and Intestinal Permeability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
143
Butyrate Formulation capsule: Take daily
Butyrate + Polyphenol Formulation capsule: Take daily
Placebo: Take daily
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States
Assessment of Gut Microbiome
Assessment of the median change in the results of the Gut Microbiome from baseline.
Time frame: 28 days
The Gastrointestinal Symptom Rating Scale (GSRS) Irritable Bowel Syndrome (IBS) version
Assessment of the median change in the responses on the Gastrointestinal Symptom Rating Scale-IBS from baseline. This scale has questions about how you have been feeling and what it has been like in the past week. The responses to each question range from no discomfort at all to very severe discomfort which would indicate a worse outcome.
Time frame: 28 days
Gut Barrier Panel
Assessment of the median change in the results of the Panel for the Gut Barrier from baseline.
Time frame: 28 days
Short Chain Fatty Acids (SCFA)
Assessment of the median change in the results of the Short Chain Fatty Acid Analysis from baseline.
Time frame: 28 days
Intestinal Permeability Test
Assessment of the median change in the results of the Intestinal Permeability Test from baseline.
Time frame: 28 days
Digestion - Associated Quality of Life Questionnaire (DQLQ)
Assessment of the median change in the responses on the Digestion- Associated Quality of Life Questionnaire (DQLQ) from baseline. The questionnaire has questions related to digestive events and experiences in the last seven days evaluated on a scale from never (0%) to always (100%). The lower score indicates an improved outcome.
Time frame: 28 days
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Visual Analogue Scale (VAS) of abdominal pain
Assessment of the median change in the responses on the Visual Analogue Scale questionnaire of abdominal pain from baseline. This scale indicates the response to the intensity of abdominal pain at the time evaluated on a scale from 0 (no pain) to 10 (severe pain). The lower the value indicates an improved outcome.
Time frame: 28 days
Bristol Stool Form Scale (English for United States)
Assessment of the median change in the stool form from baseline. This is related to asking the subject what their stool looked like each time they had a bowel movement for the day. 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: 28 days
Gastrointestinal- Global Assessment of Improvement Scale (Gastrointestinal-GAI)
Assessment of the median change in the responses on the Gastrointestinal- Global Assessment of Improvement Scale from baseline. This scale indicates the status of the gastrointestinal symptoms over the past 7 days. The responses range from substantially worse to substantially improved which would indicate an improved outcome.
Time frame: 28 days
Short Form-36 Health Survey (SF-36 Health Survey)
Assessment of the median change in the responses to the SF-36 Health Survey from baseline. This is a 36-item questionnaire that covers eight domains including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. The scores from each domain can range from 0 to 100. The higher the scores for each domain indicates a better outcome.
Time frame: 28 days