Overview

Mechanisms of Probiotics and Antibiotic-Associated Diarrhea

Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
0
Participant gender:
All
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 of the most common indications for probiotics is for prevention of antibiotic-associated diarrhea. Clinically, different probiotic strains have demonstrated the ability to prevent AAD; however, the mechanism of action behind this effect has not been elucidated. Data from several studies suggest that antibiotic-induced disruption of commensal bacteria in the colon results in a significant (up to 50%) reduction in short chain fatty acid (SCFA) production and a concomitant reduction in Na-dependent fluid absorption resulting in AAD. Probiotics have been shown to ameliorate a variety of gastrointestinal disease states and thus, the study investigators hypothesize that administration of a probiotic yogurt will protect against the development of AAD.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Georgetown University
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Penn State University
University of Maryland, Baltimore
Treatments:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
Clavulanic Acids
Criteria
Inclusion Criteria:

- 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 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

- Was a participant in the "YOBIOTIC" study