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
  Purpose

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


Condition Intervention Phase
IBS-D and Functional Dyspepsia
Dietary Supplement: Probiotic
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sprim Advanced Life Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Proportion of subjects with 1 or more adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic 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
Placebo Comparator: Placebo Dietary Supplement: Placebo
2 capsules, 3x/day placebo capsules

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268618

Locations
United States, Georgia
In-Quest Medical Research, LLC
Duluth, Georgia, United States, 30096
United States, Virginia
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Sprim Advanced Life Sciences
Investigators
Principal Investigator: Duane Wombolt, MD Clinical Research Associates of Tidewater
Principal Investigator: David Wyatt, MD In-Quest Medical Research, LLC
  More Information

No publications provided

Responsible Party: Larry Miller, PhD, Sprim Advanced Life Sciences
ClinicalTrials.gov Identifier: NCT01268618     History of Changes
Other Study ID Numbers: 10-SUS-05-NAT-01
Study First Received: December 28, 2010
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sprim Advanced Life Sciences:
IBS
Diarrhea
Dyspepsia

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Stomach Diseases

ClinicalTrials.gov processed this record on September 18, 2014