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NCT03778606 · ClinicalTrials.gov registry record · NA

Oligosaccharide for Cdiff(+) Heme-onc Patients

A NA study, sponsored by Medical College of Wisconsin.

Completed
Registry status
NA
Development phase
8
Enrollment target

NCT03778606 is a NA study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 8 participants.

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The verdict

NCT03778606, a NA study, has completed, sponsored by Medical College of Wisconsin.

COMPLETED
Registry status
NA
Development phase
8 participants
Enrollment target

Study Summary

Clostridium difficile causes \~453,000 infections and \~29,300 deaths per year in the US, making it the most common hospital acquired infection in the country. C. difficile is an anaerobic bacterium that has the capacity to inhabit the colon of humans and other mammals. Initially thought to be a commensal, it was later found to be associated with antibiotic induced enterocolitis. Since then, it has gradually become one of the most important healthcare associated pathogens. C. difficile infection (CDI) causes colitis, which is inflammation of the colonic mucosa with a spectrum of severity from mild to more protracted diarrhea, abdominal pain, fever, toxic megacolon, sepsis, and in some instances death. Mortality occurs despite the existence of three antibiotic options. CDI is also associated with higher hospital readmission rates, and associated healthcare costs in the US are estimated at 4.8 billion dollars annually. Due to the significance of C. difficile in healthcare, hospital level C. difficile rates are publically reported and closely scrutinized by the Centers for Medicare and Medicaid. Standard infection control bundles are proving to be insufficient for controlling the national C. difficile problem. Better understanding of the biological steps preceding clinical infection and reversal of the underlying gut dysbiosis will allow us to curtail our C. difficile epidemic. The present study aims to manipulate the gut microbiota to halt the biological progression of C. difficile. CDI is a serious problem in hematology-oncology patients. The incidence of CDI in the hematology-oncology population is much higher than in other populations and hematology-oncology inpatient units frequently have the highest incidence of CDI cases within an institution. Additionally, hematology-oncology patients have high rates of C. difficile colonization upon hospitalization and more than 50% of patients detected with C. difficile colonization before bone marrow transplantation end up

Interventions

  • DIETARY_SUPPLEMENT Potato starch

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2019-06-01
Est. Completion 2021-08-01
Phase NA

Sponsor

Medical College of Wisconsin

447 total trials

What the Registry Record Tells You About NCT03778606

The ClinicalTrials.gov registry entry for NCT03778606 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Potato starch is the first listed.

NCT03778606 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03778606 about?

NCT03778606 is a clinical study titled "Oligosaccharide for Cdiff(+) Heme-onc Patients". Clostridium difficile causes \~453,000 infections and \~29,300 deaths per year in the US, making it the most common hospital acquired infection in the country. C. difficile is an anaerobic bacterium that has the capacity to inhabit the colon of humans and other mammals. Initially thought to be a com...

What is the current status of trial NCT03778606?

This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2019-06-01. Estimated completion is 2021-08-01.

What interventions are being tested in trial NCT03778606?

The interventions under investigation include: Potato starch (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT03778606?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.