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

Purpose

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

Condition	Intervention	Phase
IBS-D and Functional Dyspepsia	Dietary Supplement: Probiotic Dietary Supplement: Placebo	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Indigestion

U.S. FDA Resources

Further study details as provided by Sprim Advanced Life Sciences:

Primary Outcome Measures:

Abdominal pain severity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Stool consistency (Bristol Stool Chart) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Dyspepsia Symptom Severity Index (DSSI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with 1 or more adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	January 2011
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
Placebo Comparator: Placebo	Dietary Supplement: Placebo 2 capsules, 3x/day placebo capsules

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268618

Locations

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

Sponsors and Collaborators

Sprim Advanced Life Sciences

Investigators

Principal Investigator:	Duane Wombolt, MD	Clinical Research Associates of Tidewater
Principal Investigator:	David Wyatt, MD	In-Quest Medical Research, LLC

More Information

No publications provided

Responsible Party:	Larry Miller, PhD, Sprim Advanced Life Sciences
ClinicalTrials.gov Identifier:	NCT01268618 History of Changes
Other Study ID Numbers:	10-SUS-05-NAT-01
Study First Received:	December 28, 2010
Last Updated:	July 20, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Sprim Advanced Life Sciences:

IBS
Diarrhea
Dyspepsia

Additional relevant MeSH terms:

Diarrhea
Dyspepsia
Irritable Bowel Syndrome
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional

Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Stomach Diseases

ClinicalTrials.gov processed this record on June 13, 2013