Phase
Condition
Heartburn
Stomach Discomfort
Colic
Treatment
N/AClinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 thefollowing symptoms: bothersome postprandial fullness, early satiation, epigastricpain, or epigastric burning AND no evidence of structural disease that is likely toexplain the symptoms
History of IBS-D and dyspepsia symptoms for at least 12 weeks
Agree to use contraception throughout study period, unless postmenopausal orsurgically sterile (females only)
Able to understand the nature and purpose of the study including potential risks andside 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% productcompliance and completion of required questionnaires
Exclusion
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 10years
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 disorderwithin 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 ofscreening
Study Design
Connect with a study center
In-Quest Medical Research, LLC
Duluth, Georgia 30096
United StatesSite Not Available
Clinical Research Associates of Tidewater
Norfolk, Virginia 23507
United StatesSite Not Available
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