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Recruiting NCT07355634

Terraflora Daily Care and Gastrointestinal Health

No phase Interventional Gastrointestinal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Synbiotic Dietary Supplement, Placebo.
Who it may be relevant to
Registry conditions: Gastrointestinal. Basic parameters: from 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Dietary supplement Synbiotic Dietary Supplement
    12 weeks of supplementation with Enviromedica - Terraflora Daily Care
  • Dietary supplement Placebo
    Placebo capsule

Primary outcome measures

  • GA-Map Dysbiosis on GI360 Profile [Time frame: 4 weeks, 12 weeks]
Secondary outcome measures (2)
  • Percentage of participants with dysfunction on GI360 Profile [Time frame: 4 weeks, 12 weeks]
  • Gastrointestinal Symptom Rating Scale [Time frame: 4 weeks, 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • OvationLab — Richmond

Identifiers

NCT: NCT07355634 · ENV-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗