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

NCT01268618 | Terminated Phase 2

• 1 other identifier: 10-SUS-05-NAT-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Conditions

IBS-D and Functional Dyspepsia

Keywords

IBS; Diarrhea; Dyspepsia

Outcome Measures

Primary Outcomes (3)

• Abdominal pain severity

  8 weeks

• Stool consistency (Bristol Stool Chart)

  8 weeks

• Dyspepsia Symptom Severity Index (DSSI)

  8 weeks

Secondary Outcomes (1)

• Proportion of subjects with 1 or more adverse events

  8 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Probiotic

Placebo DIETARY_SUPPLEMENT

2 capsules, 3x/day placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sprim Advanced Life Sciences: lead

Study Sites (2)

In-Quest Medical Research, LLC

Duluth, Georgia, 30096, United States

Location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Diarrhea; Dyspepsia

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Duane Wombolt, MD

  Clinical Research Associates of Tidewater

  PRINCIPAL INVESTIGATOR

• David Wyatt, MD

  In-Quest Medical Research, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 31, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

US (2)