Status:
COMPLETED
Mechanisms of Probiotics and Antibiotic-Associated Diarrhea
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
University of Maryland, Baltimore
Conditions:
Antibiotic-associated Diarrhea
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
The focus of the study is to better understand the mechanisms causing antibiotic-associated diarrhea (AAD) and how probiotics may prevent some of the iatrogenic effects of antibiotic medications. One ...
Detailed Description
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. One of the most common indications for probiotic treatment is the prevention of ant...
Eligibility Criteria
Inclusion
- Has the ability to read, speak, and write in English
- Has a refrigerator (for proper storage of the study yogurt)
- Has reliable telephone access
- Is between ages of 18-65 years
- Agree to refrain from eating yogurts, yogurt drinks, and other foods specified in the provided list
- Agree to collect stool samples and participate in follow-up calls as specified
Exclusion
- Diabetes or asthma that requires medication
- Allergy to strawberry
- Active diarrhea (three or more loose stools per day for two consecutive days)
- Any gastrointestinal (or digestive tract) medications, i.e. medicines for irritable bowel syndrome, gastroesophageal (acid) reflux disease, inflammatory bowel disease, etc.
- History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic
- History of gastrointestinal surgery or disease
- Lactose intolerance that prevents participant from eating yogurt
- Allergy to milk-protein
- Allergy to any component of the product or the yogurt vehicle
- Allergy to penicillin or cephalosporin class antibiotics
- Allergy to any of the following medications: a) Penicillin; b) Erythromycin; c) Tetracycline; d) Trimethoprim; e) Ciprofloxacin
- Women who are breastfeeding, pregnant, or planning to become pregnant during the study
- Was a participant in the "YOBIOTIC" study
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04414722
Start Date
January 1 2021
End Date
May 1 2023
Last Update
February 25 2025
Active Locations (1)
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1
Georgetown University Department of Family Medicine
Washington D.C., District of Columbia, United States, 20007