NCT05367479

Brief Summary

This study randomizes patients to two commonly used peri-procedural antibiotics after gastric bypass with the pre and post-operative collection of stool samples, to identify significant differences in relative abundances of gut microbiota phyla, genera and species between the two antibiotic groups used. Gastric bypass may beneficially affect hypertension by altering the post-operative microbiome and specific antibiotics can further enhance the resolution rate by improving microbial diversity and richness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

May 5, 2022

Last Update Submit

May 5, 2022

Conditions

Obesity, MorbidHypertensionBariatric Surgery Candidate

Keywords

gut microbiome

Outcome Measures

Primary Outcomes (1)

  • operational taxonomic units

    a distinct bacterial community

    3 months postoperatively

Study Arms (2)

Cefazolin

ACTIVE COMPARATOR

standard of care as a pre-operative antibiotic given with 60 minutes of incision before gastric bypass surgery. given intravenous as a single dose, weight based.

Drug: Antibiotic

Clindamycin

ACTIVE COMPARATOR

also standard of care alternative as a pre-operative antibiotic given with 60 minutes of incision before gastric bypass surgery. given intravenous as a single dose, weight based.

Drug: Antibiotic

Interventions

AntibioticDRUG

Peri-operative, intravenous antibiotic for surgical site infection

CefazolinClindamycin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Obesity, MorbidHypertension

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 10, 2022

Study Start

July 18, 2018

Primary Completion

January 9, 2020

Study Completion

January 9, 2020

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)