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Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

Primary Purpose

Recurrent Gastrointestinal Symptoms

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Trenev Trio®/Healthy Trinity®

Placebo

About this trial

This is an interventional treatment trial for Recurrent Gastrointestinal Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age ≥18 years
Body mass index between 18.5 through 39.9 kg/m2
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
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
Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
Able to understand and voluntarily consent to the study and understand it's nature and purpose including potential risks, and side effects

Exclusion Criteria:

Any GSRS symptom rated a 7 in severity (very severe discomfort) on a 1 to 7 scale
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
Any non-gastrointestinal disease/complication that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints
Regular (>3 days per week) prescription medication use for any gastrointestinal disease/condition
Recent (<6 months) abdominal surgery for any reason
Immunodeficiency
Recent change in anti-psychotic medication within the previous 3 months
Systemic steroid use within the prior month, excluding regular use of asthma medication
Pregnant female or breastfeeding
Eating disorder
Recent (within 2 weeks) antibiotic administration
History of alcohol, drug, or medication abuse
Daily consumption of probiotics, fermented milk, and/or yogurt
Known allergies to any substance in the study product
Participation in another study with any investigational product within 30 days of screening

Sites / Locations

Axis Clinical Trials
Sprim ALS
Research Across America
Research Across America
Clinical Research Associates of Tidewater

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo capsule

Trenev Trio®/Healthy Trinity®

Arm Description

40 subjects allocated to daily placebo capsule for 10 weeks

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

Outcomes

Primary Outcome Measures

Mean total Gastrointestinal Symptom Rating Scale (GSRS) score

Gastrointestinal Quality of Life Index (GIQLI) total score

Secondary Outcome Measures

Gastrointestinal Symptom Rating Scale subscores

Gas severity

Bloating severity

Acid indigestion severity

Abdominal cramping severity

Stool consistency (measured with Bristol Stool Form Scale)

Stool frequency

Concomitant medication use

Adverse event frequency

Adverse event severity

Full Information

NCT ID

NCT01444859

First Posted

September 28, 2011

Last Updated

October 23, 2012

Sponsor

Sprim Advanced Life Sciences

Collaborators

The National Institute of Probiotics

1. Study Identification

Unique Protocol Identification Number

NCT01444859

Brief Title

Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

Official Title

Effect of Trenev Trio®/Healthy Trinity® in Otherwise Healthy Adults With Recurrent Gastrointestinal Symptoms: a Double-blind, Randomized, Placebo-controlled, Parallel Group Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sprim Advanced Life Sciences

Collaborators

The National Institute of Probiotics

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Gastrointestinal Symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo capsule

Arm Type

Placebo Comparator

Arm Description

40 subjects allocated to daily placebo capsule for 10 weeks

Arm Title

Trenev Trio®/Healthy Trinity®

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Trenev Trio®/Healthy Trinity®

Other Intervention Name(s)

Probiotic, Active

Intervention Description

Trenev Trio®/Healthy Trinity® (1 capsule, 2x/day for 10 weeks), which offers a daily dose of: a) Lactobacillus acidophilus NAS strain (10 billion CFU), b) Bifidobacterium bifidum Malyoth strain (40 billion CFU), and c) Lactobacillus delbrueckii subspecies bulgaricus LB-51 strain (10 billion CFU)

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Other Intervention Name(s)

Inactive, Control

Intervention Description

Daily placebo for 10 weeks

Primary Outcome Measure Information:

Title

Mean total Gastrointestinal Symptom Rating Scale (GSRS) score

Time Frame

10 weeks

Title

Gastrointestinal Quality of Life Index (GIQLI) total score

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Gastrointestinal Symptom Rating Scale subscores

Time Frame

10 weeks

Title

Gas severity

Time Frame

10 weeks

Title

Bloating severity

Time Frame

10 weeks

Title

Acid indigestion severity

Time Frame

10 weeks

Title

Abdominal cramping severity

Time Frame

10 weeks

Title

Stool consistency (measured with Bristol Stool Form Scale)

Time Frame

10 weeks

Title

Stool frequency

Time Frame

10 weeks

Title

Concomitant medication use

Time Frame

10 weeks

Title

Adverse event frequency

Time Frame

10 weeks

Title

Adverse event severity

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years Body mass index between 18.5 through 39.9 kg/m2 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 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 Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only) Able to understand and voluntarily consent to the study and understand it's nature and purpose including potential risks, and side effects Exclusion Criteria: Any GSRS symptom rated a 7 in severity (very severe discomfort) on a 1 to 7 scale 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 Any non-gastrointestinal disease/complication that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints Regular (>3 days per week) prescription medication use for any gastrointestinal disease/condition Recent (<6 months) abdominal surgery for any reason Immunodeficiency Recent change in anti-psychotic medication within the previous 3 months Systemic steroid use within the prior month, excluding regular use of asthma medication Pregnant female or breastfeeding Eating disorder Recent (within 2 weeks) antibiotic administration History of alcohol, drug, or medication abuse Daily consumption of probiotics, fermented milk, and/or yogurt Known allergies to any substance in the study product Participation in another study with any investigational product within 30 days of screening

Overall Study Officials: