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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: IBS-D and Functional Dyspepsia

In brief

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

Key facts

Study ID

NCT01268618

Run by

Sprim Advanced Life Sciences

People needed

120

Starts

2011-01-01

Expected to finish

2011-08-01

Last updated by the study team

2011-07-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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