Phase
Condition
Hyponatremia
Constipation
Colic
Treatment
Placebo
Butyrate + Polyphenol Formulation
Clinical Study ID
Ages 25-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, age 25-70 years
Body mass index 18.5-34.9 kg/m2
A GSRS-IBS score ≥ 21 (identification as having moderate or severe gastrointestinalsymptoms). If the GSRS-IBS score is < 20 (identification of minimal or mild), may beincluded at the discretion of the PI/Sub-I
Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, orconstipation)
Healthy based on medical history and without chronic disease (unless permitted inthe judgment of the PI/Sub-I)
Weight stable for the past six months (±6 lbs.)
Willing and able to give written informed consent
Ability to communicate and read in English
Ability to comply with study requirements
Exclusion
Exclusion Criteria:
Currently participating in another clinical research study
Pregnant, planning pregnancy, or breastfeeding
Unable to swallow capsules, tablets, or softgels
Male participants and females of childbearing potential who are unwilling to use anacceptable method of contraception from screening through 30 days after studycompletion.
Typically goes longer than 3 days without a bowel movement
Current diagnosis of cardiovascular disease, history of an abnormalelectrocardiogram (ECG), diabetes (Type 1 or Type 2), or cancer (except fornon-melanoma skin cancer) within the past 5 years
Having had a medical or surgical event in the past 5 years involvinghospitalization, outpatient, or emergency care that requires ongoing monitoring.
Planning to undergo a major medical procedure or surgical event within the next 30days
Currently being treated for any infectious disease
Currently consuming more than 6 standard alcoholic drinks per week for women and 10drinks per week for men (a standard alcoholic drink is defined as one bottle/can ofbeer, one glass of wine, or one ounce of hard liquor)
Smoking or use of nicotine products daily within 30 days prior to screening
Using substances of abuse or recreational drugs/substances, includingtetrahydrocannabinol (THC), within the past 14 days
History of intolerance or allergic reaction to product ingredients, includingbutyrate, tributyrin, polyphenols (Green tea extract, Grape Seed extract, Cinnamonextract, maltodextrin, silicon dioxide, magnesium stearate, or chlorophyllin)
Having donated blood or received a blood/plasma transfusion within 30 days beforebaseline
History of a major change in dietary habits within the past 1 month
Currently taking any supplements containing butyrate, tributyrin, or polyphenols andnot willing to stop for the duration of study participation
Currently taking any laxatives on a daily basis
Initiated (Glucagon-Like Peptide-1) GLP-1 medication within 3 months prior toscreening.
On a stable dose of a proton pump inhibitor (e.g., omeprazole, pantoprazole) within 3 months prior to screening.
History of oral or IV antibiotic use within the past 3 months prior to Baseline
Not willing to refrain from taking any over-the-counter medications or supplementsfor gastrointestinal concerns or discomfort (except if on a stable dose for > 3months before Screening and unlikely to change) unless in the judgment of thePI/Sub-I
Current or previous history of medically diagnosed and treated gastrointestinaldisease, including gallbladder problems, gallstones, biliary obstruction,inflammatory bowel disease (IBD), Crohn's disease, Ulcerative Colitis, Celiacdisease, or gastrointestinal cancer
Currently diagnosed with and/or being treated for Irritable Bowel Syndrome (IBS)
Currently experiencing or previously having a gastrointestinal infection (viral orbacterial) or food poisoning within the past month
Currently experiencing or previously having a parasitic infection within the past 3months
Currently experiencing or having a history of severe endometriosis
History of gastrointestinal surgery, which might influence gastrointestinal function
History or presence of a clinically significant diagnosis or circumstance that, inthe judgment of the Study Investigator/Sub-I, would interfere with theinterpretation of the study results and preclude participation in the study -
Study Design
Study Description
Connect with a study center
Life Extension Clinical Research, Inc.
Fort Lauderdale 4155966, Florida 4155751 33304
United StatesActive - Recruiting

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