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Oral Lavage with Nu-Lytely for Clostridium Difficile Colitis (COLITIS Trial)
COLITIS Trial Summary
This trial is testing a possible new treatment for c. diff infection. If you have c. diff, you may be given an 8oz glass of PEG 3350 solution to drink every ten minutes until you have had 6 liters. If the infection is still not gone, you may be given 2 more liters. You will also receive 500 cc of Normal saline I.V. and continue with antibiotic treatment. The investigators will check your c. diff tests daily and track mortality, length of stay, ICU days, surgical intervention, and APACHE scores. They will also record whether you are immunocompromised or not.
COLITIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOLITIS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COLITIS Trial Design
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Who is running the clinical trial?
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- I needed surgery when my condition was first diagnosed.I am 18 or older and have tested positive for C. diff.I have a severe blockage in my intestines.I am under 18 years old.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Group 1: Control
- Group 2: Nu-Lytely
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is Nu-Lytely a secure medication for users?
"Based on the Phase 4 status of this medication, there is ample evidence to support Nu-Lytely's safety; therefore Power has awarded it a rating of 3."
To what common medical ailments is Nu-Lytely typically administered?
"Nu-Lytely is a medication utilized to treat dyschezia and additional disorders like exophthalmos, constipation, and colonoscopy."
Is this investigation currently accepting new participants?
"Unfortunately, this investigation is no longer recruiting. Initially posted on June 1st 2012 and last edited August 16th 2012, it has since concluded. If searching for alternate studies, there are 247 medical trials currently enrolling participants with colitis and an additional 16 investigations actively admitting patients to Nu-Lytely treatments."
Are there any other investigations which have focused on the efficacy of Nu-Lytely?
"Currently, 16 clinical trials are running to explore Nu-Lytely's efficacy; none of these studies is in the late phase 3 stage. This investigation is based primarily out of Tempe, Arizona but has 25 other sites conducting research as well."
What is the cap on enrollees for this clinical investigation?
"This clinical trial is not currently seeking new enrollees. As the study was last amended on August 16th, 2012 and initially posted June 1st of that same year, it appears to be inactive at this time. However, 247 trials for colitis and a further 16 studies related to Nu-Lytely are actively recruiting patients."
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