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Oral Lavage with Nu-Lytely for Clostridium Difficile Colitis (COLITIS Trial)

Phase 4
Waitlist Available
Led By Mark B. Vance, DO
Research Sponsored by Ascension Genesys Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years old or older male or female testing positive for c. diff
Be older than 18 years old
Must not have
Severe ileus or small bowel obstruction
Less than 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

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.

Who is the study for?
Adults over 18 who have tested positive for C. diff infection can participate, except pregnant individuals, those needing surgery at diagnosis, or with severe ileus/small bowel obstruction.
What is being tested?
The trial tests if drinking Nu-Lytely solution improves outcomes in patients with C. diff before the illness worsens. Participants will also receive IV fluids and continue antibiotic treatment while being monitored daily.
What are the potential side effects?
Nu-Lytely may cause nausea, bloating, stomach cramps, and diarrhea due to increased bowel movements as it cleanses the colon.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and have tested positive for C. diff.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a severe blockage in my intestines.
Select...
I am under 18 years old.
Select...
I needed surgery when my condition was first diagnosed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Length of stay
Secondary study objectives
Need for surgery

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Standard of care.
Group II: Nu-LytelyActive Control1 Intervention
Bowel prep solution.

Find a Location

Who is running the clinical trial?

Ascension Genesys HospitalLead Sponsor
18 Previous Clinical Trials
1,863 Total Patients Enrolled
Ascension HealthLead Sponsor
26 Previous Clinical Trials
2,650 Total Patients Enrolled
Mark B. Vance, DOPrincipal InvestigatorGRMC

Media Library

Nu-Lytely (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01630096 — Phase 4
Clostridium Difficile Colitis Clinical Trial 2023: Nu-Lytely Highlights & Side Effects. Trial Name: NCT01630096 — Phase 4
Clostridium Difficile Colitis Research Study Groups: Control, Nu-Lytely
Nu-Lytely (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01630096 — Phase 4
~15 spots leftby Dec 2025
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