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Trenev Trio/Healthy Trinity for Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS) and Functional Dyspepsia

This study has been terminated.
Sponsor:
Information provided by:
Sprim Advanced Life Sciences
ClinicalTrials.gov Identifier:
NCT01268618
First received: December 28, 2010
Last updated: July 20, 2011
Last verified: July 2011

December 28, 2010
July 20, 2011
January 2011
August 2011   (final data collection date for primary outcome measure)
  • Abdominal pain severity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Stool consistency (Bristol Stool Chart) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Dyspepsia Symptom Severity Index (DSSI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01268618 on ClinicalTrials.gov Archive Site
Proportion of subjects with 1 or more adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Trenev Trio/Healthy Trinity for Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS) and Functional Dyspepsia
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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
IBS-D and Functional Dyspepsia
  • Dietary Supplement: Probiotic

    2 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: Placebo
    2 capsules, 3x/day placebo capsules
  • Experimental: Probiotic
    Intervention: Dietary Supplement: Probiotic
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18 to 75 years
  2. 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
  3. 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
  4. History of IBS-D and dyspepsia symptoms for at least 12 weeks
  5. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
  6. Able to understand the nature and purpose of the study including potential risks and side effects
  7. Willing to consent to study participation and to comply with study requirements
  8. Successful completion of 2-week placebo-only run-in period, defined as ≥90% product compliance and completion of required questionnaires

Exclusion Criteria:

  1. Major gastrointestinal complication, e.g. Crohn's disease or ulcer
  2. Prior abdominal surgery with the exception of hernia repair and appendectomy
  3. Subjects over 60 years who have not had a sigmoidoscopy or colonoscopy in the past 10 years
  4. Clinically significant systemic disease
  5. Life expectancy < 6 months
  6. Pregnant female or breastfeeding
  7. Lactose intolerance
  8. Immunodeficient subjects
  9. Anti-psychotic medication within the prior 3 months or major psychiatric disorder within the past 2 years
  10. Systemic steroids within the prior month
  11. Current treatment with nasogastric tube, ostomy, or parenteral nutrition
  12. Use of proton pump inhibitors
  13. Eating disorder
  14. Recent (< 2 weeks) antibiotic administration
  15. History of alcohol, drug, or medication abuse
  16. Daily consumption of probiotics, fermented milk, and/or yogurt
  17. Known allergies to any substance in the study product
  18. Participation in another study with any investigational product within 3 months of screening
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01268618
10-SUS-05-NAT-01
No
Larry Miller, PhD, Sprim Advanced Life Sciences
Sprim Advanced Life Sciences
Not Provided
Principal Investigator: Duane Wombolt, MD Clinical Research Associates of Tidewater
Principal Investigator: David Wyatt, MD In-Quest Medical Research, LLC
Sprim Advanced Life Sciences
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP