Actively Recruiting

Phase Not Applicable
Age: 25Years - 65Years
FEMALE
NCT06834984

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

Led by Colorado State University · Updated on 2025-11-14

60

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

Sponsors

C

Colorado State University

Lead Sponsor

R

Ritual

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 25Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adult women aged 25 to 65 years
  • BMI less than 30
  • Moderate gastrointestinal symptoms
  • Willingness to follow the study protocol and attend clinic visits
Not Eligible

You will not qualify if you...

  • Age younger than 25 years or older than 65 years
  • BMI greater than 30
  • Antibiotic use within two months or probiotic use within 14 days before treatment
  • Use of medications or supplements that may affect study results, including statins, metformin, NSAIDs, MAO inhibitors, and hormone therapies
  • Current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, or cardiometabolic disorders
  • Pregnant or breastfeeding
  • Excessive alcohol use based on self-report
  • Inability to adhere to study requirements including capsule intake, sample collection, symptom tracking, and clinic visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Colorado State University Food and Nutrition Clinical Research Laboratory

Fort Collins, Colorado, United States, 80523

Actively Recruiting

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Research Team

D

Dr. Tiffany Weir, PhD

CONTACT

J

Jenny Whittington, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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