Ritual Synbiotic+, a Dietary Supplement Designed to Impact Gastrointestinal Health, Mood, and Beh… (NCT06834984) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Ritual Synbiotic+, a Dietary Supplement Designed to Impact Gastrointestinal Health, Mood, and Behavior in Women
United States60 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range
25 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.