Recurrent Gastrointestinal SymptomsPhase 2/3NCT01444859
Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms
A Phase 2/3 study testing Trenev Trio®/Healthy Trinity® in people with Recurrent Gastrointestinal Symptoms, run by Sprim Advanced Life Sciences at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recurrent Gastrointestinal Symptoms
- What is being tested?
- Trenev Trio®/Healthy Trinity®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2012to Nov 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Across America
Carrollton, Texas, 75010
Axis Clinical Trials
Los Angeles, California, 90036
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
Sprim ALS
San Francisco, California, 94109
Research Across America
West Lawn, Pennsylvania, 19609
About this study
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
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.
Read the 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.
- Conditions
- Recurrent Gastrointestinal Symptoms
- Being tested
- Trenev Trio®/Healthy Trinity®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trenev Trio®/Healthy Trinity®Dietary supplement
Also called Probiotic, Active
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)
PlaceboDietary supplement
Also called Inactive, Control
Daily placebo for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo capsule | Placebo comparator | 40 subjects allocated to daily placebo capsule for 10 weeks Receives: Dietary Supplement: Placebo |
| Trenev Trio®/Healthy Trinity® | Experimental | 80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks Receives: Dietary Supplement: Trenev Trio®/Healthy Trinity® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean total Gastrointestinal Symptom Rating Scale (GSRS) score
Measured: 10 weeks
Gastrointestinal Quality of Life Index (GIQLI) total score
Measured: 10 weeks
Secondary outcomes (10)
Gastrointestinal Symptom Rating Scale subscores
Measured: 10 weeks
Gas severity
Measured: 10 weeks
Bloating severity
Measured: 10 weeks
Acid indigestion severity
Measured: 10 weeks
Abdominal cramping severity
Measured: 10 weeks
Stool consistency (measured with Bristol Stool Form Scale)
Measured: 10 weeks
Stool frequency
Measured: 10 weeks
Concomitant medication use
Measured: 10 weeks
Adverse event frequency
Measured: 10 weeks
Adverse event severity
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Gastrointestinal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sprim Advanced Life Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The National Institute of Probiotics
- Responsible party
- Sponsor
- Investigators
- Duane Wombolt, MD, Principal investigator, Clinical Research Associates of TidewaterJeffrey Stewart, MD, Principal investigator, Research Across AmericaMichael Sinitsa, MD, Principal investigator, Research Across AmericaHelen Stacey, MD, Principal investigator, Diablo Clinical ResearchLydie Hazan, MD, Principal investigator, Axis Clinical TrialsJoAnn Hattner, MPH, RD, Principal investigator, Sprim ALS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444859
- Sponsor's protocol ID
- 110725-SUS-NIP-GIS-RA
- Status last verified
- Dec 2011
- First submitted
- 28 Sep 2011
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01444859
- Acronym / sponsor ID
- 110725-SUS-NIP-GIS-RA
- Conditions
- Recurrent Gastrointestinal Symptoms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sprim Advanced Life SciencesUniversity, hospital or other
- Collaborators
- The National Institute of Probiotics
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (estimated)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo capsule | Placebo comparator | Dietary Supplement: Placebo40 subjects allocated to daily placebo capsule for 10 weeks |
| Trenev Trio®/Healthy Trinity® | Experimental | Dietary Supplement: Trenev Trio®/Healthy Trinity®80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trenev Trio®/Healthy Trinity®Also: Probiotic, ActiveTrenev 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) | Dietary supplement | Trenev Trio®/Healthy Trinity® |
| PlaceboAlso: Inactive, ControlDaily placebo for 10 weeks | Dietary supplement | Placebo capsule |
Primary outcome
Mean total Gastrointestinal Symptom Rating Scale (GSRS) score
Time frame: 10 weeks
Gastrointestinal Quality of Life Index (GIQLI) total score
Time frame: 10 weeks
10 secondary outcomes
Gastrointestinal Symptom Rating Scale subscores
Time frame: 10 weeks
Gas severity
Time frame: 10 weeks
Bloating severity
Time frame: 10 weeks
Acid indigestion severity
Time frame: 10 weeks
Abdominal cramping severity
Time frame: 10 weeks
Stool consistency (measured with Bristol Stool Form Scale)
Time frame: 10 weeks
Stool frequency
Time frame: 10 weeks
Concomitant medication use
Time frame: 10 weeks
Adverse event frequency
Time frame: 10 weeks
Adverse event severity
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
Related trials for Recurrent Gastrointestinal Symptoms
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 1/2
A Study of MDSY-1240, a STAT3 Degrader, for the Treatment of Hematologic Malignancies and Advanced Solid Tumors
Triple-Negative Breast Cancer (TNBC), Gastric Cancer (GC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duane Wombolt, MD principal investigator
Clinical Research Associates of Tidewater
Jeffrey Stewart, MD principal investigator
Research Across America
Michael Sinitsa, MD principal investigator
Research Across America
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Trenev Trio®/Healthy Trinity® in people with Recurrent Gastrointestinal Symptoms, run by Sprim Advanced Life Sciences at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean total Gastrointestinal Symptom Rating Scale (GSRS) score (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.