Trial | NCT01268618  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    120
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 Started
Jan 31
2011
Primary Completion
Aug 31
2011
Anticipated
Study Completion
Aug 31
2011
Anticipated
Last Update
Jul 21
2011
Estimate

Dietary Supplement Probiotic

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

Dietary Supplement Placebo

2 capsules, 3x/day placebo capsules

Probiotic Experimental

Placebo Placebo Comparator

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
No Results Posted