Antibiotic-Associated Diarrhea and the Role of Microorganisms in the Gut

This is an interventional basic science trial for Antibiotic-associated Diarrhea focused on measuring amoxicillin-clavulanate, diarrhea, Gut microbiome Read More

Inclusion Criteria:

1. Healthy adults, 21-40 years of age at time of screening
2. Satisfactory baseline medical assessment as assessed by physical examination and a stable health status. The laboratory values must be within the normal range of the assessing site or show abnormalities that are deemed not clinically significant as judged by the investigator. A stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event.
3. Accessible vein for blood collection.
4. Subjects who are willing to comply with the requirements of the study protocol and scheduled visits. (e.g., completion of the subject diary, return for follow-up visits) and who are willing to make themselves available for the duration of the study, with access to a consistent means of telephone contact, which may be either at home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device (i.e. a common-use phone serving multiple rooms or apartments).
5. Ability to provide informed consent
6. Female subjects of non-child bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Post-menopausal subjects must have had at least 12 months of natural (spontaneous) amenorrhea.
7. Female subjects of childbearing potential may be enrolled in the study if they have negative urine pregnancy tests on the day of screening and day of antibiotic administration.
8. Willing to abstain from the use of probiotics or prebiotics for the duration of the study.

Exclusion Criteria:

1. Underlying chronic medical illness
2. History of Clostridium difficile diarrhea
3. History of Inflammatory Bowel disease or any other chronic gastrointestinal tract illness
4. Known drug allergy to amoxicillin-clavulanate, its components, or any other beta-lactam antibiotics.
5. Presence of acute infection in the preceding 7 days or presence of a temperature ≥ 38.0°C (oral or tympanic temperature assessment), or acute symptoms greater than of "mild" severity on the scheduled date of first dose
6. Any condition that, in the opinion of the investigator, would complicate or compromise the study or wellbeing of the subject.
7. Woman who is pregnant or breast feeding.
8. Evidence of substance abuse, or previous substance abuse including alcohol
9. Participation in a study involving administration of an investigational compound within the past three months, or planned participation during the duration of this study.
10. Receipt of antibiotics in the past 3 months.
11. Receipt of probiotics or prebiotics in the past 7 days.
12. Previous history of Augmentin-associated jaundice and/or hepatic dysfunction.