Gastrointestinal SymptomsPhase 2/3NCT02277431
Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms
A Phase 2/3 study testing Probiotic dietary supplement (Trenev Trio®) in people with Gastrointestinal Symptoms and Bloating, run by University of Maryland, Baltimore.
Trial summary
Participants experiencing recurrent gastrointestinal symptoms in this double-blind, randomized, controlled trial will receive either a commercially-available probiotic dietary supplement or placebo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Symptoms, Bloating, Gas
- What is being tested?
- Probiotic dietary supplement (Trenev Trio®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Oct 2015
- 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
- Self-reported response of "moderate discomfort" or worse (3 or greater on 1-5 Likert Scale) and "frequent discomfort" or more often (3 or greater on 1-5 Likert scale) from at least 2 of the following gastrointestinal symptoms: gas, indigestion, bloating, abdominal pain, or defecation irregularity as expressed on Likert scale (1=very minor or no discomfort, 2=minor discomfort, 3=moderate discomfort, 4=high discomfort, 5=very high discomfort) over the previous 3 weeks
- Agree to continue with typical diet and exercise habits during study
- Agree to use contraception or abstinence throughout study period, unless postmenopausal or surgically sterile (females only)
- Able to understand and voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
Who cannot join
- Current and documented diagnosis of Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis), Celiac disease, active peptic ulcer, active diverticulitis, and other active cases of gastrointestinal diseases that, in the investigators' opinions, may affect participant safety.
- Current and documented diagnosis of any other non-gastrointestinal disease that, in the investigators' opinions, may affect participant safety or confound the evaluation of the study outcomes. Excluded conditions include congestive heart failure, malignancy, uncontrolled diabetes mellitus, uncontrolled autoimmune disease (lupus, rheumatoid arthritis, eczema), eating disorders, and any other active health condition or disease that the investigators feel contradict the intended study population of participants in good health.
- Daily consumption of another probiotic supplement or new consumption of fermented dairy products (yogurt, kefir, etc.)
- Usage of systemic steroids during the past 2 months
- Usage of antipsychotic medications during the past 2 months
- Usage of prednisone, 6-mercaptopurine, adalimumab, etanercept, infliximab, leflunomide, golimumab, or mycophenolate mofetil during the past 2 months
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- Uncontrolled anxiety or current medication for anxiety disorder
- Pregnant or breastfeeding females
- History of alcohol, drug, or medication abuse
- Known allergies to any substance in the study product
- Previous major gastrointestinal tract surgery (colon resection, gastric bypass, etc.)
- Participation in another clinical trial within 30 days of screening
About this study
Official title: A Randomized Controlled Trial of a Commercially-Available Probiotic Supplement (Trenev Trio®/Healthy Trinity®) and the Promotion of Normal Gastrointestinal Function Among Adults With Recurrent Gastrointestinal Symptoms
Participants experiencing recurrent gastrointestinal symptoms in this double-blind, randomized, controlled trial will receive either a commercially-available probiotic dietary supplement or placebo. The investigators hypothesize that participants in the probiotic dietary supplement group will experience greater improvement in their gastrointestinal symptoms than participants in the placebo group.
- Conditions
- Gastrointestinal Symptoms, Bloating, Gas, Indigestion, Abdominal Pain, Defecation Irregularity
- Being tested
- Probiotic dietary supplement (Trenev Trio®), placebo
- Medical subject headings
- Mucopolysaccharidosis IV, Dyspepsia, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic dietary supplement (Trenev Trio®)Dietary supplement
Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am \& pm) offering a total daily serving of:
- Lactobacillus acidophilus NAS super strain (10 billion Colony Forming Units [CFU])
- Bifidobacterium bifidum Malyoth super strain (40 billion CFU)
- Lactobacillus delbrueckii subspecies bulgaricus LB-51 super strain (10 billion CFU)
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotic dietary supplement | Experimental | Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am \& pm) offering a total daily serving of:
* Lactobacillus acidophilus NAS super strain (10 billion Colony Forming Units [CFU])
* Bifidobacterium bifidum Malyoth super strain (40 billion CFU)
* Lactobacillus delbrueckii subspecies bulgaricus LB-51 super strain (10 billion CFU) Receives: Dietary Supplement: Probiotic dietary supplement (Trenev Trio®) |
| Placebo | Placebo comparator | The placebo capsules utilized in this study will be indistinguishable from the probiotic dietary supplement capsules as they will be identical in appearance, odor, weight, and taste. Furthermore, the same sunflower oil matrix will be in both the probiotic dietary supplement and placebo. The only difference between the dietary supplement and placebo capsules will be the probiotic bacteria. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of self-reported bloating
Likert scale
Measured: Study end (6 weeks from baseline)
Severity of self-reported gas
Likert scale
Measured: Study end (6 weeks from baseline)
Severity of self-reported indigestion
Likert scale
Measured: Study end (6 weeks from baseline)
Severity of self-reported abdominal pain
Likert scale
Measured: Study end (6 weeks from baseline)
Severity of self-reported defecation irregularity
Likert scale
Measured: Study end (6 weeks from baseline)
Secondary outcomes (5)
Frequency of self-reported bloating
Likert scale
Measured: Study end (6 weeks from baseline)
Frequency of self-reported gas
Likert scale
Measured: Study end (6 weeks from baseline)
Frequency of self-reported indigestion
Likert scale
Measured: Study end (6 weeks from baseline)
Frequency of self-reported abdominal pain
Likert scale
Measured: Study end (6 weeks from baseline)
Frequency of self-reported defecation irregularity
Likert scale
Measured: Study end (6 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SymptomsStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris D'Adamo, University of Maryland, Baltimore
- Investigators
- Chris D'Adamo, PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277431
- Sponsor's protocol ID
- 00007145
- Status last verified
- Sep 2021
- First submitted
- 24 Oct 2014
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Commercially-Available Probiotic Supplement (Trenev Trio®/Healthy Trinity®) and the Promotion of Normal Gastrointestinal Function Among Adults With Recurrent Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT02277431
- Acronym / sponsor ID
- 00007145
- Conditions
- Gastrointestinal Symptoms, Bloating, Gas, Indigestion, Abdominal Pain, Defecation Irregularity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Oct 2014 (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.
Participants experiencing recurrent gastrointestinal symptoms in this double-blind, randomized, controlled trial will receive either a commercially-available probiotic dietary supplement or placebo. The investigators hypothesize that participants in the probiotic dietary supplement group will experience greater improvement in their gastrointestinal symptoms than participants in the placebo group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic dietary supplement | Experimental | Dietary Supplement: Probiotic dietary supplement (Trenev Trio®)Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am \& pm) offering a total daily serving of: * Lactobacillus acidophilus NAS super strain (10 billion Colony Forming Units [CFU]) * Bifidobacterium bifidum Malyoth super strain (40 billion CFU) * Lactobacillus delbrueckii subspecies bulgaricus LB-51 super strain (10 billion CFU) |
| Placebo | Placebo comparator | Dietary Supplement: placeboThe placebo capsules utilized in this study will be indistinguishable from the probiotic dietary supplement capsules as they will be identical in appearance, odor, weight, and taste. Furthermore, the same sunflower oil matrix will be in both the probiotic dietary supplement and placebo. The only difference between the dietary supplement and placebo capsules will be the probiotic bacteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-reported response of "moderate discomfort" or worse (3 or greater on 1-5 Likert Scale) and "frequent discomfort" or more often (3 or greater on 1-5 Likert scale) from at least 2 of the following gastrointestinal symptoms: gas, indigestion, bloating, abdominal pain, or defecation irregularity as expressed on Likert scale (1=very minor or no discomfort, 2=minor discomfort, 3=moderate discomfort, 4=high discomfort, 5=very high discomfort) over the previous 3 weeks
- Agree to continue with typical diet and exercise habits during study
- Agree to use contraception or abstinence throughout study period, unless postmenopausal or surgically sterile (females only)
- Able to understand and voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
Key exclusion criteria (12 listed)
- Current and documented diagnosis of Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis), Celiac disease, active peptic ulcer, active diverticulitis, and other active cases of gastrointestinal diseases that, in the investigators' opinions, may affect participant safety.
- Current and documented diagnosis of any other non-gastrointestinal disease that, in the investigators' opinions, may affect participant safety or confound the evaluation of the study outcomes. Excluded conditions include congestive heart failure, malignancy, uncontrolled diabetes mellitus, uncontrolled autoimmune disease (lupus, rheumatoid arthritis, eczema), eating disorders, and any other active health condition or disease that the investigators feel contradict the intended study population of participants in good health.
- Daily consumption of another probiotic supplement or new consumption of fermented dairy products (yogurt, kefir, etc.)
- Usage of systemic steroids during the past 2 months
- Usage of antipsychotic medications during the past 2 months
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 |
|---|---|---|
| Probiotic dietary supplement (Trenev Trio®)Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am \& pm) offering a total daily serving of: * Lactobacillus acidophilus NAS super strain (10 billion Colony Forming Units [CFU]) * Bifidobacterium bifidum Malyoth super strain (40 billion CFU) * Lactobacillus delbrueckii subspecies bulgaricus LB-51 super strain (10 billion CFU) | Dietary supplement | Probiotic dietary supplement |
| placebo | Dietary supplement | Placebo |
Primary outcome
Severity of self-reported bloating
Time frame: Study end (6 weeks from baseline)
Likert scale
Severity of self-reported gas
Time frame: Study end (6 weeks from baseline)
Likert scale
Severity of self-reported indigestion
Time frame: Study end (6 weeks from baseline)
Likert scale
Severity of self-reported abdominal pain
Time frame: Study end (6 weeks from baseline)
Likert scale
Severity of self-reported defecation irregularity
Time frame: Study end (6 weeks from baseline)
Likert scale
5 secondary outcomes
Frequency of self-reported bloating
Time frame: Study end (6 weeks from baseline)
Frequency of self-reported gas
Time frame: Study end (6 weeks from baseline)
Frequency of self-reported indigestion
Time frame: Study end (6 weeks from baseline)
Frequency of self-reported abdominal pain
Time frame: Study end (6 weeks from baseline)
Frequency of self-reported defecation irregularity
Time frame: Study end (6 weeks from baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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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.
Chris D'Adamo, PhD principal investigator
University of Maryland, College Park
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Probiotic dietary supplement (Trenev Trio®) in people with Gastrointestinal Symptoms and Bloating, run by University of Maryland, Baltimore.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Severity of self-reported bloating (time frame: Study end (6 weeks from baseline)). The study lists 5 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 14 Sep 2021.