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

Last updated: July 20, 2011
Sponsor: Sprim Advanced Life Sciences
Overall Status: Terminated

Phase

2/3

Condition

Heartburn

Stomach Discomfort

Colic

Treatment

N/A

Clinical Study ID

NCT01268618
10-SUS-05-NAT-01
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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 thefollowing symptoms: bothersome postprandial fullness, early satiation, epigastricpain, or epigastric burning AND no evidence of structural disease that is likely toexplain 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 orsurgically sterile (females only)

  6. Able to understand the nature and purpose of the study including potential risks andside 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% productcompliance and completion of required questionnaires

Exclusion

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 10years

  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 disorderwithin 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 ofscreening

Study Design

Total Participants: 120
Study Start date:
January 01, 2011
Estimated Completion Date:
August 31, 2011

Connect with a study center

  • In-Quest Medical Research, LLC

    Duluth, Georgia 30096
    United States

    Site Not Available

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia 23507
    United States

    Site Not Available

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