Oligosaccharide for Cdiff(+) Heme-onc Patients

NCT03778606 | Completed

• 1 other identifier: PRO00033794
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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 diagnosed with hospital associated CDI. This finding is not trivial as CDI treatment with oral vancomycin causes major and prolonged perturbations of their intestinal microbiota, which has been associated with higher mortality. In addition to the usual complications of CDI, a higher incidence of graft-versus-host-disease has been described in patients with CDI.

Conditions

Clostridium Difficile; Hematologic Diseases

Keywords

Clostridium difficile; Asymptomatic carrier; Potato starch; Non digestable oligosaccharide

Outcome Measures

Primary Outcomes (3)

• Stool samples will be collected twice a week while on potato starch supplementation and 1 time at 7-days post- starch supplementation to assess any changes in the frequency of collection during the 21-day period.

  Samples will be collected twice a week (4-5 times during supplementation) and one time at day 21 or discharge, whichever happens first.

  Day 1- Day 21

• Oligosaccharide intake assessed by a patient diary to measure supplementation feasibility

  Patients will be provided with a diary in which they will document compliance with oligosaccharide intake. It is anticipated ≥70% of intended doses to be fully administered by the patient.

  Day 1-Day 14

• The feasibility of collecting all available stool samples stool will be assessed. A rate ≥50% of correctly collected and processed samples will be considered feasible.

  It is expected ≥50% of stool samples to be correctly collected and processed.

  Day 1-Day 14

Secondary Outcomes (2)

• Changes in C. difficile loads will be assessed using C. difficile quantitative polymerase chain reaction (qPCR).

  Day 1-Day 14

• Changes in Firmicutes' relative abundance due to oligosaccharide supplementation measured by 16S rRNA gene sequencing

  Day 1-Day 14

Study Arms (1)

Potato starch supplementation

EXPERIMENTAL

Twelve patients found to be colonized with C. difficile will undergo twice a day potato starch supplementation.

Dietary Supplement: Potato starch

Interventions

Potato starch DIETARY_SUPPLEMENT

Potato starch will be given twice a day for up to 14 days, discharge, or death, whichever occurs first.

Potato starch supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be at least 18 years of age at time of consent.
• Positive C. difficile surveillance test.
• Absence of diarrhea or abdominal pain within the past 48 hours.
• Patient admitted in a hematology-oncology unit which for the purposes of this study will be defined as 7-CFAC and 8-CFAC.

You may not qualify if:

• Presence of \>= grade I nausea/vomiting.
• Inability to take oral medications or food.
• Expected length of hospitalization or survival less than 5 days
• Patient is only boarding in hematology-oncology units and would have not otherwise been admitted to these units.
• Unwillingness or inability to provide written informed consent.
• Women known to be pregnant or lactating during the study.
• History of inflammatory bowel disease.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 19, 2018
• Study Start: June 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: August 1, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

US (1)