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