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

Study Overview

• Status: Terminated
• Conditions: IBS-D and Functional Dyspepsia
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Duluth, Georgia, United States, 30096
      • In-Quest Medical Research, LLC
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Associates of Tidewater

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; 2 capsules, 3x/day placebo capsules
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: Lactobacillus acidophilus NAS, 30 billion CFU; Bifidobacterium bifidum Malyoth, 120 billion CFU; Lactobacillus delbrueckii subspecies bulgaricus LB-51, 30 billion CFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Abdominal pain severity	8 weeks
Stool consistency (Bristol Stool Chart)	8 weeks
Dyspepsia Symptom Severity Index (DSSI)	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with 1 or more adverse events	8 weeks

Collaborators and Investigators

• Sponsor: Sprim Advanced Life Sciences
• Investigators: Principal Investigator: David Wyatt, MD, In-Quest Medical Research, LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ANTICIPATED): August 1, 2011
• Study Completion (ANTICIPATED): August 1, 2011

Study Registration Dates

• First Submitted: December 28, 2010
• First Submitted That Met QC Criteria: December 30, 2010
• First Posted (ESTIMATE): December 31, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 21, 2011
• Last Update Submitted That Met QC Criteria: July 20, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Diarrhea; IBS; Dyspepsia
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Dyspepsia; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: 10-SUS-05-NAT-01