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Clostridial Infection and Oral Lavage -Improving Treatment Before Illness Becomes Severe (COLITIS)

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ClinicalTrials.gov Identifier: NCT01630096
Recruitment Status : Unknown
Verified August 2012 by Mark Vance, Genesys Regional Medical Center.
Recruitment status was:  Recruiting
First Posted : June 28, 2012
Last Update Posted : August 17, 2012
Sponsor:
Information provided by (Responsible Party):
Mark Vance, Genesys Regional Medical Center

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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Colitis Drug: Nu-Lytely Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: COLITIS: Clostridial Infection and Oral Lavage -Improving Treatment Before Illness Becomes Severe
Study Start Date : June 2012
Estimated Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Nu-Lytely
Bowel prep solution.
Drug: Nu-Lytely
Bowl prep solution.
Other Names:
  • Polyethylene Glycol 3350
  • PEG 3350
No Intervention: Control
Standard of care.



Primary Outcome Measures :
  1. Length of stay [ Time Frame: 30 days ]
    Days


Secondary Outcome Measures :
  1. Need for surgery [ Time Frame: 30 days ]
    Did the subject have an operation, if so what was it (colectomy/illeostomy&lavage).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630096


Locations
United States, Michigan
Genesys Regional Medical Center Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Kimberly Barber, PhD    810-606-7724      
Sponsors and Collaborators
Genesys Regional Medical Center
Investigators
Principal Investigator: Mark B. Vance, DO GRMC

Responsible Party: Mark Vance, DO, Attending Surgeon, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT01630096     History of Changes
Other Study ID Numbers: GRMC 12 0008
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: August 17, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Colitis
Clostridium Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents