Terraflora Daily Care and Gastrointestinal Health
ConditionGastrointestinal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorOvationLab
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Synbiotic Dietary Supplement
Dietary supplement12 weeks of supplementation with Enviromedica - Terraflora Daily Care
Placebo
Dietary supplementPlacebo capsule
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Terraflora - Daily CareExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
GA-Map Dysbiosis on GI360 Profile
Time frame
4 weeks, 12 weeksSecondary outcomes
1
Percentage of participants with dysfunction on GI360 Profile
Time frame
4 weeks, 12 weeks2
Gastrointestinal Symptom Rating Scale
Minimum value: 1, Maximum value: 7, Higher scores represent more severe/troublesome symptoms.
Time frame
4 weeks, 12 weeks Source ClinicalTrials.gov