NCT01630096

Brief Summary

Once the lab test is positive for c. diff, the investigators will order the patient to have PEG 3350 solution, one 8oz glass every ten minutes until 6 liters are gone, but if still not clear 2 more liters may be ordered. At enrollment, the treatment arm will have an order for 500 cc Normal saline to be given I.V. The patient will continue with antibiotic treatment as well. The investigators will plan to check c. diff tests daily to see when they become negative. The investigators will perform chart audit/review to track mortality, the length of stay, ICU days, surgical intervention, and APACHE scores (assessment of disease severity). Chart audit will be used to collect data on their diet and how they feel using a visual analog scale (collected by nursing staff daily as a standard procedure; see attached pain scale). Using chart audit, the investigators will record whether the patient is immunocompromised or not.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

August 17, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

June 21, 2012

Last Update Submit

August 16, 2012

Conditions

Clostridium Difficile Colitis

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    Days

    30 days

Secondary Outcomes (1)

  • Need for surgery

    30 days

Study Arms (2)

Nu-Lytely

ACTIVE COMPARATOR

Bowel prep solution.

Drug: Nu-Lytely

Control

NO INTERVENTION

Standard of care.

Interventions

Nu-LytelyDRUG

Bowl prep solution.

Also known as: Polyethylene Glycol 3350, PEG 3350
Nu-Lytely

Eligibility Criteria

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

You may qualify if:

  • years old or older male or female testing positive for c. diff

You may not qualify if:

  • Pregnancy Less than 18 yrs of age Those sick enough to require surgery at diagnosis Severe ileus or small bowel obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous

Interventions

polyethylene glycol 3350

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Mark B. Vance, DO

    GRMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DO, Attending Surgeon

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 28, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Last Updated

August 17, 2012

Record last verified: 2012-08

Locations

US(1)