Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance
NCT ID: NCT03597516
Last Updated: 2019-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
557 participants
INTERVENTIONAL
2018-06-26
2019-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RP-G28
galacto-oligosaccharide, spray-dried powder for reconstitution for oral administration, 7.5 grams 2 times per day
RP-G28
powder for reconstitution for oral administration
Placebos
maltodextrin, powder for reconstitution for oral administration, 7.5 grams 2 times per day
Placebos
powder for reconstitution for oral administration
Interventions
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RP-G28
powder for reconstitution for oral administration
Placebos
powder for reconstitution for oral administration
Eligibility Criteria
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Inclusion Criteria
* Intolerance to milk and other dairy products;
* Patient agrees to refrain from all other treatments and products used for lactose intolerance, to follow diet modifications required during periods of the study that include abstinence from all dairy in some periods and consuming dairy in other periods;
* Patient meets the defined minimum lactose intolerance symptom composite score; and
* Patient has positive Hydrogen Breath Test (HBT) results for lactase deficiency.
Exclusion Criteria
* Patient has undergone bowel preparation for endoscopic or radiologic investigation within 4 weeks of Screening (example, colonoscopy preparation);
* Patient has a history of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: fundoplication, gastrointestinal bypass surgery, bariatric surgery, gastric banding, colostomy, vagotomy, pyloroplasty, colectomy or other surgery for Crohn's disease or ulcerative colitis; and
* Patient has received antibiotic treatment, or had a high colonic enema, colonic irrigation, colonic hydrotherapy, or colonic cleaning within 30 days prior to or during Screening.
18 Years
75 Years
ALL
No
Sponsors
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Ritter Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sharron Gargosky, PhD
Role: STUDY_DIRECTOR
Ritter Pharmceuticals, Inc.
Locations
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Research Facility
Birmingham, Alabama, United States
Research Site
Chula Vista, California, United States
Research Site
Huntington Park, California, United States
Research Site
Lincoln, California, United States
Research Site
Los Angeles, California, United States
Research Site
Panorama City, California, United States
Research Site
San Diego, California, United States
Research Site
San Diego, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Gainesville, Florida, United States
Research Facility
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Reseaarch Site
Pompano Beach, Florida, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Marrero, Louisiana, United States
Research Site
Oxon Hill, Maryland, United States
Research Site
Wyoming, Michigan, United States
Research Site
Omaha, Nebraska, United States
Research Site
Berlin, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Brooklyn, New York, United States
Research Site
Great Neck, New York, United States
Research Site
Hartsdale, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Charleston, South Carolina, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Lampasas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Waxahachie, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Bellevue, Washington, United States
Countries
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Other Identifiers
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G28-006
Identifier Type: -
Identifier Source: org_study_id
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