IBS-D and Functional DyspepsiaPhase 2/3NCT01268618
Trenev Trio/Healthy Trinity for Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS) and Functional Dyspepsia
A Phase 2/3 study testing Probiotic in people with IBS-D and Functional Dyspepsia, run by Sprim Advanced Life Sciences at 2 sites in United States.
Trial summary
Primary Objective: To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia Secondary Objective: To confirm the safety of the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS-D and Functional Dyspepsia
- What is being tested?
- Probiotic
- 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
- 2 sitesUnited States
- Study dates
- Jan 2011to Aug 2011
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years
- Diagnosed with IBS-D including: a) weekly average of worst abdominal pain in the last 24 hours of ≥3 on a 0-10 scale, and b) weekly average of Bristol Stool form of ≥6 on a 1-7 scale
- Diagnosed with functional dyspepsia defined as presence of at least one of the following symptoms: bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning AND no evidence of structural disease that is likely to explain the symptoms
- History of IBS-D and dyspepsia symptoms for at least 12 weeks
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- Able to understand the nature and purpose of the study including potential risks and side effects
- Willing to consent to study participation and to comply with study requirements
- Successful completion of 2-week placebo-only run-in period, defined as ≥90% product compliance and completion of required questionnaires
Who cannot join
- Major gastrointestinal complication, e.g. Crohn's disease or ulcer
- Prior abdominal surgery with the exception of hernia repair and appendectomy
- Subjects over 60 years who have not had a sigmoidoscopy or colonoscopy in the past 10 years
- Clinically significant systemic disease
- Life expectancy < 6 months
- Pregnant female or breastfeeding
Show all 18Show fewer
- Lactose intolerance
- Immunodeficient subjects
- Anti-psychotic medication within the prior 3 months or major psychiatric disorder within the past 2 years
- Systemic steroids within the prior month
- Current treatment with nasogastric tube, ostomy, or parenteral nutrition
- Use of proton pump inhibitors
- Eating disorder
- Recent (< 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 3 months of screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
In-Quest Medical Research, LLC
Duluth, Georgia, 30096
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Dual-center Study on the Effect of Healthy Trinity (Retail Label)/Trenev Trio (Professional Label) on Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) and Functional Dyspepsia
Primary Objective:
- To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia
Secondary Objective:
- To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in adult patients with IBS-D and functional dyspepsia
- Conditions
- IBS-D and Functional Dyspepsia
- Being tested
- Probiotic, Placebo
- Keywords
- IBS, Diarrhea, Dyspepsia
- Medical subject headings
- Diarrhea, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
2 capsules, 3x/day capsules of Healthy Trinity (retail label)/Trenev Trio (professional label), for a total daily dose of:
- Lactobacillus acidophilus NAS, 30 billion CFU
- Bifidobacterium bifidum Malyoth, 120 billion CFU
- Lactobacillus delbrueckii subspecies bulgaricus LB-51, 30 billion CFU
PlaceboDietary supplement
2 capsules, 3x/day placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Not described Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain severity
Measured: 8 weeks
Stool consistency (Bristol Stool Chart)
Measured: 8 weeks
Dyspepsia Symptom Severity Index (DSSI)
Measured: 8 weeks
Secondary outcomes (1)
Proportion of subjects with 1 or more adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS-D and Functional DyspepsiaStudies 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
- Investigators
- Duane Wombolt, MD, Principal investigator, Clinical Research Associates of TidewaterDavid Wyatt, MD, Principal investigator, In-Quest Medical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268618
- Sponsor's protocol ID
- 10-SUS-05-NAT-01
- Status last verified
- Jul 2011
- First submitted
- 28 Dec 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Dual-center Study on the Effect of Healthy Trinity (Retail Label)/Trenev Trio (Professional Label) on Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) and Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT01268618
- Acronym / sponsor ID
- 10-SUS-05-NAT-01
- Conditions
- IBS-D and Functional Dyspepsia
- Keywords
- IBS, Diarrhea, Dyspepsia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sprim Advanced Life SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 31 Dec 2010 (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.
Primary Objective:
- To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia
Secondary Objective:
- To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in adult patients with IBS-D and functional dyspepsia
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 |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 75 years
- Diagnosed with IBS-D including: a) weekly average of worst abdominal pain in the last 24 hours of ≥3 on a 0-10 scale, and b) weekly average of Bristol Stool form of ≥6 on a 1-7 scale
- Diagnosed with functional dyspepsia defined as presence of at least one of the following symptoms: bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning AND no evidence of structural disease that is likely to explain the symptoms
- History of IBS-D and dyspepsia symptoms for at least 12 weeks
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
Key exclusion criteria (18 listed)
- Major gastrointestinal complication, e.g. Crohn's disease or ulcer
- Prior abdominal surgery with the exception of hernia repair and appendectomy
- Subjects over 60 years who have not had a sigmoidoscopy or colonoscopy in the past 10 years
- Clinically significant systemic disease
- Life expectancy < 6 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 |
|---|---|---|
| Probiotic2 capsules, 3x/day capsules of Healthy Trinity (retail label)/Trenev Trio (professional label), for a total daily dose of: 1. Lactobacillus acidophilus NAS, 30 billion CFU 2. Bifidobacterium bifidum Malyoth, 120 billion CFU 3. Lactobacillus delbrueckii subspecies bulgaricus LB-51, 30 billion CFU | Dietary supplement | Probiotic |
| Placebo2 capsules, 3x/day placebo capsules | Dietary supplement | Placebo |
Primary outcome
Abdominal pain severity
Time frame: 8 weeks
Stool consistency (Bristol Stool Chart)
Time frame: 8 weeks
Dyspepsia Symptom Severity Index (DSSI)
Time frame: 8 weeks
1 secondary outcome
Proportion of subjects with 1 or more adverse events
Time frame: 8 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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
David Wyatt, MD principal investigator
In-Quest Medical Research, LLC
2 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 Probiotic in people with IBS-D and Functional Dyspepsia, run by Sprim Advanced Life Sciences at 2 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 8 inclusion and 18 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: stopped early, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was stopped early. 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?
Abdominal pain severity (time frame: 8 weeks). The study lists 3 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 21 Jul 2011.