Back to resultsTrenev Trio/Healthy Trinity for Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS) and Functional Dyspepsia
Primary Purpose
IBS-D and Functional Dyspepsia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for IBS-D and Functional Dyspepsia focused on measuring IBS, Diarrhea, Dyspepsia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- In-Quest Medical Research, LLC
- Clinical Research Associates of Tidewater
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Abdominal pain severity
Stool consistency (Bristol Stool Chart)
Dyspepsia Symptom Severity Index (DSSI)
Secondary Outcome Measures
Proportion of subjects with 1 or more adverse events
Full Information
NCT ID
NCT01268618
First Posted
December 28, 2010
Last Updated
July 20, 2011
Sponsor
Sprim Advanced Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01268618
Brief Title
Trenev Trio/Healthy Trinity for Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS) and Functional Dyspepsia
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sprim Advanced Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in adult patients with IBS-D and functional dyspepsia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS-D and Functional Dyspepsia
Keywords
IBS, Diarrhea, Dyspepsia
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
Probiotic
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
2 capsules, 3x/day placebo capsules
Primary Outcome Measure Information:
Title
Abdominal pain severity
Time Frame
8 weeks
Title
Stool consistency (Bristol Stool Chart)
Time Frame
8 weeks
Title
Dyspepsia Symptom Severity Index (DSSI)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects with 1 or more adverse events
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duane Wombolt, MD
Organizational Affiliation
Clinical Research Associates of Tidewater
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Wyatt, MD
Organizational Affiliation
In-Quest Medical Research, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
In-Quest Medical Research, LLC
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trenev Trio/Healthy Trinity for Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS) and Functional Dyspepsia
We'll reach out to this number within 24 hrs