Overview

This trial aims to study the mechanisms behind how probiotics can prevent the effects of antibiotic-associated diarrhea (AAD). While probiotics are commonly used for preventing AAD, the mechanism has not been identified or backed up by sufficient research. Investigators hypothesize that probiotic yogurt will help protect against the development of AAD.

Study Information

In this study, investigators are looking for 60 participants who will be split into control and experimental arms. The experimental group will receive yogurt with BB-12 and Amoxicillin-Clavulanate while the control group will receive the same yogurt without the drugs. Participants will then be monitored for 30 days to see the effects.

Inclusion Criteria

• Has the ability to read, speak, and write in English
• Has 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 What Not to Eat list
• Agree to collect stool samples and participate in follow-up calls as specified

Exclusion Criteria

• 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

Location

Georgetown University Department of Family Medicine

Washington, District of Columbia, United States, 20007

Contact: Keisha A Herbin Smith, MA    202-687-6454    

Principal Investigator: Daniel J Merenstein, MD   

Sponsors/Collaborators

Georgetown University

National Center for Complementary and Integrative Health (NCCIH)

University of Maryland, Baltimore