Terraflora Daily Care and Gastrointestinal Health
A Randomized, Placebo-Controlled Trial Evaluating the Impact of a Synbiotic Dietary Supplement on Markers of Gastrointestinal Health
1 other identifier
interventional
40
1 country
1
Brief Summary
A 12-week, randomized, double-blind, placebo-controlled clinical trial will be conducted evaluating the effectiveness of Enviromedica - Terraflora Daily Care on markers of gastrointestinal function and symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2026
CompletedStudy Start
First participant enrolled
January 12, 2026
CompletedFirst Posted
Study publicly available on registry
January 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
April 22, 2026
April 1, 2026
5 months
January 2, 2026
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
GA-Map Dysbiosis Test
4 weeks, 12 weeks
Secondary Outcomes (3)
Percentage of participants with dysfunction on GI360 Profile
4 weeks, 12 weeks
Percentage of participants with dysfunction on Thorne Gut Health Test
4 weeks, 12 weeks
Gastrointestinal Symptom Rating Scale
4 weeks, 12 weeks
Study Arms (2)
Terraflora - Daily Care
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
12 weeks of supplementation with Enviromedica - Terraflora Daily Care
Eligibility Criteria
You may qualify if:
- Adult males or females age ≥ 25 years
- Ability to read and speak English
- Dysbiosis (≥3 on GA-Map Dysbiosis Score) on a stool test (GI360 Profile, Doctor's Data, St. Charles, Illinois)
You may not qualify if:
- Daily use within the past month of any probiotic or prebiotic supplement
- Current diagnosis of inflammatory bowel disease, including Crohn's or ulcerative colitis
- Current daily usage of non-steroidal anti-inflammatory drugs (NSAID), proton pump inhibitors (PPI), or antibiotic medications
- Current daily tobacco smoker
- Known allergies to any substance in the study products
- Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks
- Current diagnosis of any other chronic health condition (e.g., cancer, chronic kidney disease) deemed clinically contraindicated for the study protocol
- Current participation in another clinical trial
- Participants unable to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OvationLablead
Study Sites (1)
OvationLab
Richmond, Virginia, 23220, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2026
First Posted
January 21, 2026
Study Start
January 12, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share