Terraflora Daily Care for gastrointestinal health
A Randomized, Placebo-Controlled Trial Evaluating the Impact of a Synbiotic Dietary Supplement on Markers of Gastrointestinal Health
NA · OvationLab · NCT07355634
We will test whether taking Terraflora Daily Care, a synbiotic supplement, for 12 weeks helps adults with dysbiosis improve gut function and symptoms compared with a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | OvationLab (network) |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT07355634 on ClinicalTrials.gov |
What this trial studies
This is a 12-week randomized, double-blind, placebo-controlled trial comparing Terraflora Daily Care, a synbiotic dietary supplement, to a placebo. Adults aged 25 and older with dysbiosis confirmed by a GA-Map stool test (score ≥3) will be enrolled at a single site in Richmond, Virginia. Participants who recently used probiotics or who have inflammatory bowel disease, other clinically significant chronic conditions, ongoing use of NSAIDs, PPIs, or antibiotics, or who are pregnant, breastfeeding, or daily smokers will be excluded. The study will track changes in objective markers of gastrointestinal function from stool testing and self-reported GI symptoms over the treatment period.
Who should consider this trial
Good fit: Adults aged 25 or older who read and speak English and have dysbiosis (GA-Map dysbiosis score ≥3) on a qualifying stool test, and who are not taking excluded medications or supplements, are ideal candidates.
Not a fit: People with inflammatory bowel disease, other clinically significant chronic health conditions, daily smokers, pregnant or breastfeeding women, those on daily NSAIDs/PPIs/antibiotics, or recent probiotic users may not benefit or be eligible.
Why it matters
Potential benefit: If successful, Terraflora Daily Care could offer a non-prescription synbiotic option to reduce GI symptoms and improve objective markers of gut function for adults with dysbiosis.
How similar studies have performed: Previous studies of probiotics and synbiotics have shown mixed results with some modest symptom and microbiome marker improvements but no definitive, broadly accepted benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult males or females age ≥ 25 years 2. Ability to read and speak English 3. Dysbiosis (≥3 on GA-Map Dysbiosis Score) on a stool test (GI360 Profile, Doctor's Data, St. Charles, Illinois) Exclusion Criteria: 1. Daily use within the past month of any probiotic or prebiotic supplement 2. Current diagnosis of inflammatory bowel disease, including Crohn's or ulcerative colitis 3. Current daily usage of non-steroidal anti-inflammatory drugs (NSAID), proton pump inhibitors (PPI), or antibiotic medications 4. Current daily tobacco smoker 5. Known allergies to any substance in the study products 6. Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks 7. Current diagnosis of any other chronic health condition (e.g., cancer, chronic kidney disease) deemed clinically contraindicated for the study protocol 8. Current participation in another clinical trial 9. Participants unable to provide consent
Where this trial is running
Richmond, Virginia
- OvationLab — Richmond, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Chris D'Adamo, Ph.D.
- Email: chris@ovationlab.com
- Phone: 240-232-2103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrointestinal