Ritual Synbiotic+, a Dietary Supplement
Colorado State University
Summary
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.
Description
The trial will be a double-blinded, randomized, placebo-controlled parallel arm intervention study taking place at Colorado State University. In total, \~100 adult women (25-65 years old) with a BMI \<30, with moderate digestive discomfort (as evidenced by a moderate score on a functional gastrointestinal questionnaire will be enrolled into the study. With an estimated 20% attrition rate, this will allow approximately 80 individuals to complete the study. Exclusion criteria include a BMI\>30, any significant systemic diseases (including Crohn's, Ulcerative Colitis, but not including diagnosis…
Eligibility
- Age range
- 25–65 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- Dietary SupplementPrebiotic, probiotic, postbiotic combination
The product consists of two probiotics, Lactobacillus rhamnosus LGG and Bifidibacterium animalis subsp. lactis BB-12, supplied at a total concentration of 11B CFU's, a prebiotic consisting of 1 × 106 Plaque Forming Units (PFU) LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae bacteriophages, marketed as PreforPro, and tributyrin- a stale form of butyrate
- Dietary SupplementPlacebo
Placebo pill containing stomach acid-resistant outer vegan capsule (hypromellose, gellan gum), hi oleic safflower oil, inner vegan capsule (hypromellose, gellan gum) microcrystalline cellulose, ascorbyl palmitate, silica
Location
- Colorado State University Food and Nutrition Clinical Research LaboratoryFort Collins, Colorado