IBS-D and Functional Dyspepsia
Conditions
Keywords
IBS, Diarrhea, Dyspepsia
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
Interventions
DIETARY_SUPPLEMENTProbiotic
2 capsules, 3x/day capsules of Healthy Trinity (retail label)/Trenev Trio (professional label), for a total daily dose of: 1. Lactobacillus acidophilus NAS, 30 billion CFU 2. Bifidobacterium bifidum Malyoth, 120 billion CFU 3. Lactobacillus delbrueckii subspecies bulgaricus LB-51, 30 billion CFU
DIETARY_SUPPLEMENTPlacebo
2 capsules, 3x/day placebo capsules
Sponsors
Sprim Advanced Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal pain severity | 8 weeks |
| Stool consistency (Bristol Stool Chart) | 8 weeks |
| Dyspepsia Symptom Severity Index (DSSI) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with 1 or more adverse events | 8 weeks |
Countries
United States
Outcome results
None listed