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Clinical Trials/NCT07355634
NCT07355634RecruitingNot Applicable

A Randomized, Placebo-Controlled Trial Evaluating the Impact of a Synbiotic Dietary Supplement on Markers of Gastrointestinal Health

OvationLab1 site in 1 country40 target enrollmentStarted: January 12, 2026Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
GA-Map Dysbiosis Test
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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)

Exclusion Criteria

  • •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

Arms & Interventions

Terraflora - Daily Care

Experimental

Intervention: Synbiotic Dietary Supplement (Dietary Supplement)

Placebo

Placebo Comparator

Intervention: Placebo (Dietary Supplement)

Outcomes

Primary Outcomes

GA-Map Dysbiosis Test

Time Frame: 4 weeks, 12 weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor
OvationLab
Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (1)

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