NCT04682522

Brief Summary

This study will compare the types of bacteria in the colon before and after colon resection surgery. The investigator will also compare standard post-operative antibiotic treatment to flagyl (metronidazole) treatment post-operatively to see if giving the antibiotic, decreases the incidence of return of Crohn's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2021

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 21, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2.4 years

First QC Date

December 9, 2020

Last Update Submit

October 18, 2023

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • Change in bacteria in the gut

    Any change in the types of bacteria in the gut during the study period. This will be done by doing genetic analysis of differences in stool over time.

    six months

Study Arms (2)

Metronidazole

ACTIVE COMPARATOR

Metronidazole 250 mg three times a day

Drug: Metronidazole Oral

Standard care

NO INTERVENTION

Standard post-operative care, which may or may not include post-operative antibiotics

Interventions

Metronidazole OralDRUG

250 mg Three times a day

Also known as: Flagyl
Metronidazole

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old who is deemed an acceptable surgical candidate for ileocolic resection.

You may not qualify if:

  • any patients that are dependent on total parenteral nutrition and unable to tolerate oral intake
  • patients who will undergo resection but will have an ileostomy created
  • patients on maintenance antibiotics for their disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Surgical Associates

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sandra Kavalukas, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized 1:1 study groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 23, 2020

Study Start

March 21, 2021

Primary Completion

August 15, 2023

Study Completion

August 15, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

US(1)