IBS-D and Functional Dyspepsia Clinical Trial
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
| Verified date | July 2011 |
| Source | Sprim Advanced Life Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 120 |
| Est. completion date | August 2011 |
| Est. primary completion date | August 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | In-Quest Medical Research, LLC | Duluth | Georgia |
| United States | Clinical Research Associates of Tidewater | Norfolk | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Sprim Advanced Life Sciences |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Abdominal pain severity | 8 weeks | No | |
| Primary | Stool consistency (Bristol Stool Chart) | 8 weeks | No | |
| Primary | Dyspepsia Symptom Severity Index (DSSI) | 8 weeks | No | |
| Secondary | Proportion of subjects with 1 or more adverse events | 8 weeks | Yes |