Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics

• Status: Completed
• Trial end date: 2020-01-08
• 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); University of Maryland; University of Maryland, Baltimore
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

1. Has the ability to read, speak, and write in English

2. Has refrigerator (for proper storage of the study yogurt)

3. Has reliable telephone access

4. Is between ages of 18-65 years

5. Agree to refrain from eating yogurts, yogurt drinks, and other foods specified in the provided What Not to Eat list

6. Agree to collect stool samples and participate in follow-up calls as specified

Exclusion Criteria:

1. Diabetes or asthma that requires medication

2. Allergy to strawberry

3. Active diarrhea (three or more loose stools per day for two consecutive days)

4. Any gastrointestinal (or digestive tract) medications, i.e. medicines for irritable bowel syndrome, gastroesophageal (acid) reflux disease, inflammatory bowel disease, etc.

5. History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic

6. History of gastrointestinal surgery or disease

7. Lactose intolerance that prevents participant from eating yogurt

8. Allergy to milk-protein

9. Allergy to any component of the product or the yogurt vehicle

10. Allergy to penicillin or cephalosporin class antibiotics

11. Allergy to any of the following medications: a) Penicillin; b) Erythromycin; c) Tetracycline; d) Trimethoprim; e) Ciprofloxacin

12. Women who are breastfeeding, pregnant, or planning to become pregnant during the study