NCT04156555

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

Completed Phase 4 Last updated 1 November 2022

What this trial tests

Phase 4 trial testing Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet in Antibiotic-associated Diarrhea in 30 participants. Completed in 26 October 2022.

Timeline

1 August 2019

Primary endpoint
26 October 2022

26 October 2022

Quick facts

Lead sponsor	Singapore General Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	30
Start date	1 August 2019
Primary completion	26 October 2022
Estimated completion	26 October 2022
Sites	1 location across Singapore

Drugs / interventions tested

• Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet — full drug profile →

Conditions studied

• Antibiotic-associated Diarrhea — all drugs for Antibiotic-associated Diarrhea →

Sponsor

Singapore General Hospital

Who can join

Adults 21 to 40, any sex, with Antibiotic-associated Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Amoxicillin-clavulanate is an antibiotic commonly prescribed to treat a myriad of community-acquired infections. One of the most common adverse effects of amoxicillin-clavulanate is antibiotic-associated diarrhea (AAD). Studies have shown that administration of antibiotics can cause disruption and changes in the diversity of microorganisms within the gut (gut microbiome), with overgrowth of "harmful" bacteria as a possible driver for AAD. How antibiotics specifically affect the gut microbiome to cause AAD in humans, however, remains unknown. The overall goal of the study is to characterize the changes in the gut microbiome over time, in subjects who develop AAD after antibiotic ingestion, and to further demonstrate that resolution of AAD is due to return of "friendly, anti-diarrhea bacteria". The study investigators will also measure the proteins produced by the gut bacteria, as a potential tool to help predict which individuals are at risk of AAD.

The investigators plan to recruit 30 healthy adult volunteers who will receive 3 days of oral amoxicillin-clavulanate, a very commonly prescribed antibiotic. Stool and blood samples will be collected throughout the study up to 28 days after antibiotic administration. The study investigators will measure and compare the changes in the gut microbiome and metabolic responses in order to identify the relationship between these changes and the onset of AAD. The results from this study will not only yield important scientific knowledge about the pathogenesis of AAD, but will also provide new leads to understand the interplay between the gut microbiome, immune-metabolism and AAD. These findings also have the potential to identify clinically important biomarkers to allow pre-identification of individuals at risk of AAD. If successful, this study could pave the way for personalized medicine for management of bacterial infections. This will help to prevent premature stoppage of antibiotic therapy due to diarrhea side effects, and reduce the risk of bacterial resistance from suboptimal treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.