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

Phase 2

Terminated

• Conditions: IBS-D and Functional Dyspepsia

• Registration Number: NCT01268618
• Lead Sponsor: Sprim Advanced Life Sciences

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-28
• Study First Submitted QC: 2010-12-30
• Study First Posted: 2010-12-31
• Study Start: 2011-01
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Abdominal pain severity	8 weeks
Stool consistency (Bristol Stool Chart)	8 weeks
Dyspepsia Symptom Severity Index (DSSI)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with 1 or more adverse events	8 weeks

Trial Locations

Locations (2)

In-Quest Medical Research, LLC; 🇺🇸 Duluth, Georgia, United States

Clinical Research Associates of Tidewater; 🇺🇸 Norfolk, Virginia, United States