NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Ritual Synbiotic+, a Dietary Supplement Designed to Impact Gastrointestinal Health, Mood, and Behavior in Women

CompletedNA

Sponsor: Colorado State University

Conditions: Gastrointestinal Disease Symptoms

Interventions: Prebiotic, probiotic, postbiotic combination, Placebo

Countries: United States

The aim of this study is to determine how regular consumption of Synbiotic+, a dietary supplement that contains prebiotics, probiotics, and postbiotics, impacts functional gastrointestinal health, markers of intestinal inflammation and immune health, and influences mood and behavior. The primary outcome will be to assess gastrointestinal health using bowel movement tracking, self-report and objective assessments of gastrointestinal symptom severity, stool levels of short chain fatty acids, changes in the gut microbiota, including recovery of LGG and BB-12, and functional measures of the microbiome. Secondary outcomes will include stool and blood markers of gut barrier function and intestinal inflammation, immune health, and self-assessments of stress, anxiety, sleep, and quality of life.

Eligibility overview

Sex: FEMALE

Age: 25 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Healthy adult women (age 25-65, with target average age of 50).
* BMI \<30.
* with moderate gastrointestinal symptoms.
* Participants should be willing to follow the study protocol and attend clinic visits.

Exclusion Criteria:

* less than 25 years of age or greater than 65 years of age.
* have a BMI \>30.
* taken antibiotics within two months or any probiotic supplements within the past 14 days prior to the start of treatment.
* current medications and dietary supplements will be assessed on a case-by- case basis and will result in exclusion if there is the possibility that the drugs or supplements used would influence the endpoints of the study. This would include statins, metformin, NSAIDs, MAO inhibitors, and hormone therapies.
* Individuals with current disease diagnosis, including diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and cardiometabolic disorders (cardiovascular disease, diabetes, etc.)
* pregnant and breastfeeding people.
* overuse of alcohol as determined on a case-by-case self-reported alcohol use.
* if the individual feels they are unable to adhere to the study requirements, which includes consuming capsules, providing stool or blood samples, tracking bowel movements and symptoms, and attending scheduled clinic visits.

Locations (1)

Fort Collins, Colorado, United States