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RECRUITING
NCT06834984
NA

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

Sponsor: Colorado State University

View on ClinicalTrials.gov

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.

Official title: Ritual Synbiotic+, a Dietary Supplement

Key Details

Gender

FEMALE

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-05-01

Completion Date

2025-12-31

Last Updated

2025-11-14

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Prebiotic, 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_SUPPLEMENT

Placebo

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

Locations (1)

Colorado State University Food and Nutrition Clinical Research Laboratory

Fort Collins, Colorado, United States