Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

NCT01641341 | Completed Phase 4

• 1 other identifier: 10-108
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 9

Brief Summary

Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced randomization and a cross-over to active treatment for placebo treated individuals who do not respond to the placebo treatment. Data collected will help determine the feasibility of the study design in primary care offices. Patient outcome data will provide a more precise estimate of power for a larger, classic randomized trial to determine if such a study can be reasonably undertaken within primary care practices. Aims: The aims of this pilot study are to: 1) Evaluate how well Genova Diagnostics (GDx) IBS tests can be integrated into primary care, 2) examine the effects of the Genova Diagnostics (GDx) test on treatment, and 3) observe and track patients' health, quality of life and clinical outcomes related to IBS during the study period.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Genova Diagnostics kit; Stool test; Rome III; Practice-based research; treatable parasite; Pancreatic insufficiency; Bowel dysbiosis; High levels of inflammation, C. difficile, or H. pylori

Outcome Measures

Primary Outcomes (1)

• A reduction in IBS symptoms

  20 to 40% of the control/placebo patients and approximately 70-75% of the treatment patients will experience a positive outcome as determined by both the daily log sheets and the modified Rome criteria administered at baseline, 8 and 16 weeks.

  16 weeks

Study Arms (2)

Placebo capsule

PLACEBO COMPARATOR

Placebo capsule (sugar pill with no active medication)

Drug: Placebo

Active treatment

ACTIVE COMPARATOR

Active treatment will consist of the following interventions: 1. Bowel Dysbiosis - probiotics Bifidobacterium infantis, 2. Maldigestion/Malabsorption - Pancrelipase 3. Parasitic infection/presence - Nitazoxanide

Drug: Bifidobacterium infantis; Drug: Pancrelipase; Drug: Nitazoxanide

Interventions

Bifidobacterium infantis DRUG

once a day for seven to eight weeks

Also known as: B. Bifidum, B. Breve, B. Infantis, Bifidobacterias, Bifidobacterium bifidum, Bifidum, Bifidus, Probiotic

Active treatment

Pancrelipase DRUG

Pancrelipase (one capsule prior to meals or snacks)

Also known as: Lipancreatin

Active treatment

Nitazoxanide DRUG

Nitazoxanide (500mg twice a day for 7 days)

Also known as: Alinia

Active treatment

Placebo DRUG

Placebo capsule will not contain active treatment ingredients.

Also known as: Sugar pill

Placebo capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the ages of 18 and 65 years of age
• meet Rome III criteria for IBS
• willing to complete surveys and daily symptom logs for three to four 14-day periods
• have positive symptoms for at least 3 days out of the 14 days of the baseline daily log records

You may not qualify if:

• have HIV or AIDs
• have gall stones with a gall bladder present

Sponsors & Collaborators

• American Academy of Family Physicians: lead
• Genova Diagnostics: collaborator

Study Sites (9)

Torrance Clinical Research

Lomita, California, 90717, United States

Location

Overland Park Family Health Partners

Leawood, Kansas, 66209, United States

Location

American Academy of Family Physicians-National Research Network

Leawood, Kansas, 66211, United States

Location

Baton Rouge Family Practice

Baton Rouge, Louisiana, 70806, United States

Location

Family Medicine of SE Missouri

Sikeston, Missouri, 63801, United States

Location

Missouri Delta Physician Services

Sikeston, Missouri, 63801, United States

Location

Silver Sage Center for Family Medicine

Reno, Nevada, 89521, United States

Location

Raj Kachoria

Macedon, New York, 14502, United States

Location

Southwest Family Medicine Associates

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Exocrine Pancreatic Insufficiency

Interventions

bifidus factor; Probiotics; Pancrelipase; nitazoxanide; Sugars

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pancreatic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures; Carbohydrates

Study Officials

• Evelyn Lewis & Clark, MD, MA

  National Research Network

  PRINCIPAL INVESTIGATOR

• Wilson Pace, MD

  National Research Network

  STUDY CHAIR

• Gerard Mullin, MD

  Johns Hopkins School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: July 16, 2012
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)