Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

Sprim Advanced Life Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Recurrent Gastrointestinal Symptoms

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Trenev Trio®/Healthy Trinity®

Study type: Interventional

Funder types: Other

Identifiers

NCT01444859

110725-SUS-NIP-GIS-RA

Details and patient eligibility

About

Clinical trial to compare safety and effectiveness of 10-week supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms.

Full description

This study is a double-blind, randomized, placebo-controlled, parallel group trial comparing the safety and effectiveness of supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms. Subjects will be recruited and, following successful completion of a 2-week run-in period, will be randomized to Trenev Trio®/Healthy Trinity® or placebo and will consume their assigned study product daily for 10 weeks. The study endpoints of this trial include relief of overall gastrointestinal symptoms, acid indigestion, abdominal cramping, constipation, diarrhea, gas, and bloating as well as product safety over the 10-week supplementation period.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥18 years
2. Body mass index between 18.5 through 39.9 kg/m2
3. At least three symptoms rated between 4 to 6 in severity (moderate to severe discomfort) on a 1 to 7 scale, one of which must be acid indigestion as determined by the "Reflux Syndrome" score
4. Self-reported "acid indigestion" symptoms (including pain/discomfort beneath the breastbone, bitter fluid in the mouth, or bloating/nausea after eating) at least 3 times per week over the previous 4 weeks
5. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
6. Able to understand and voluntarily consent to the study and understand it's nature and purpose including potential risks, and side effects

Exclusion criteria

1. Any GSRS symptom rated a 7 in severity (very severe discomfort) on a 1 to 7 scale
2. Diagnosed gastrointestinal disease/complication or functional bowel disorder (e.g. IBS, functional constipation, IBD, ulcer, etc.) based on physical examination or documented medical history that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints
3. Any non-gastrointestinal disease/complication that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints
4. Regular (>3 days per week) prescription medication use for any gastrointestinal disease/condition
5. Recent (<6 months) abdominal surgery for any reason
6. Immunodeficiency
7. Recent change in anti-psychotic medication within the previous 3 months
8. Systemic steroid use within the prior month, excluding regular use of asthma medication
9. Pregnant female or breastfeeding
10. Eating disorder
11. Recent (within 2 weeks) antibiotic administration
12. History of alcohol, drug, or medication abuse
13. Daily consumption of probiotics, fermented milk, and/or yogurt
14. Known allergies to any substance in the study product
15. Participation in another study with any investigational product within 30 days of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Placebo capsule

Placebo Comparator group

Description:

40 subjects allocated to daily placebo capsule for 10 weeks

Treatment:

Dietary Supplement: Placebo

Trenev Trio®/Healthy Trinity®

Experimental group

Description:

80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks

Treatment:

Dietary Supplement: Trenev Trio®/Healthy Trinity®