Clinical trial · Interventional
Oligosaccharide for Cdiff(+) Heme-onc Patients
Oligosaccharide Supplementation Among Hematology-Oncology Clostridium Difficile Colonized Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clostridium Difficile | — | UNRESOLVED | — |
| Hematologic Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Potato starch | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Potato starch supplementation
- description
- Twelve patients found to be colonized with C. difficile will undergo twice a day potato starch supplementation.
- interventionNames
- Dietary Supplement: Potato starch
Primary outcomes (3)
- measure
- 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.
- timeFrame
- Day 1- Day 21
- description
- Samples will be collected twice a week (4-5 times during supplementation) and one time at day 21 or discharge, whichever happens first.
- measure
- Oligosaccharide intake assessed by a patient diary to measure supplementation feasibility
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients must meet all inclusion criteria to be eligible to participate in the study. * 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. Exclusion Criteria: Patients must NOT meet any exclusion criteria to be eligible to participate in the study. * 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.
References
Publications (0)
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