RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-05-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06834984

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy adult women (age 25-65, with target average age of 50).
  2. * BMI \<30.
  3. * with moderate gastrointestinal symptoms.
  4. * Participants should be willing to follow the study protocol and attend clinic visits.
  1. * less than 25 years of age or greater than 65 years of age.
  2. * have a BMI \>30.
  3. * taken antibiotics within two months or any probiotic supplements within the past 14 days prior to the start of treatment.
  4. * 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.
  5. * Individuals with current disease diagnosis, including diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and cardiometabolic disorders (cardiovascular disease, diabetes, etc.)
  6. * pregnant and breastfeeding people.
  7. * overuse of alcohol as determined on a case-by-case self-reported alcohol use.
  8. * 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.

Contacts and Locations

Study Contact

Dr. Tiffany Weir, PhD
CONTACT
(970) 491-4631
tiffany.weir@colostate.edu
Jenny Whittington, MS
CONTACT
970-310-6843
ijwhitt@rams.colostate.edu

Study Locations (Sites)

Colorado State University Food and Nutrition Clinical Research Laboratory
Fort Collins, Colorado, 80523
United States

Collaborators and Investigators

Sponsor: Colorado State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Women with gastrointestinal symptoms
  • Probiotic
  • Prebiotic

Additional Relevant MeSH Terms

  • Gastrointestinal Disease Symptoms