Early Phase 1
N=66
Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics
Antibiotic-associated Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT03755765 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Level of Fecal Short-chain Fatty Acid (SCFA) Acetate — 53.1; 45.2; 42.3; 38.1 micromolar (μM)
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet (Drug); BB-12 (Biological); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Georgetown University
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of Fecal Short-chain Fatty Acid (SCFA) Acetate |
53.1; 45.2; 42.3; 38.1; 36.8; 40.8 | — |
| SECONDARY Level of Fecal SCFA Propionate |
14.3; 13.0; 14.3; 12.5; 11.8; 12.0 | — |
| SECONDARY Level of Fecal SCFA Butyrate |
12.7; 12.7; 9.0; 8.3; 7.4; 8.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03755765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.