Infections

All Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Communicable Diseases

Hematologic Diseases

Clostridium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Pharmaceutical Solutions

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Dermatologic Agents

Iron

Vancomycin

Titanium dioxide

Anti-Bacterial Agents

This group will be given vancomycin oral capsules, 125 mg, every 6 hours, for 14 days.

This group will be given placebo oral capsules every 6 hours for 14 days.

We have chosen oral vancomycin capsules as it is currently a standard of care for Clostridium difficile infections, is poorly absorbed by the intestines, and is easier to blind compared to oral vancomycin solution.

Vancomycin Oral Capsule

A capsule containing gelatin, polyethylene glycol, titanium dioxide, iron oxide, and FD\&C blue No. 2. Contains the inactive ingredients of the vancomycin oral capsule, as mixed by the Froedtert Health Research Pharmacy.

Placebo Oral Capsule

Silvia Munoz-Price, M.D., Ph.D.

This study will randomized hematology oncology patients with active diarrhea and a NAAT positive/toxin EIA negative to either 14 days of oral vancomycin capsules or placebo. The study is designed to include 30 patients (15 per arm).

Outcomes will include C. difficile load using qPCR, VRE loads, structural and functional microbiome changes and frequency of bowel movements. All endpoints will be measured at several time points including days 0, 14, 21 and 90.

The adverse health consequences resulting from antibiotic overtreatment of NAAT(+), toxin(-) patients may be particularly important in transplant recipients. The usual treatment prescribed for CDI at the Froedtert Memorial Lutheran Hospital is oral vancomycin. While this drug has excellent activity against C. difficile and commonly suppresses its growth to non-detection, it does not eradicate carriage and its use results in marked and prolonged disruption of the lower intestinal microbiota. Meanwhile, the degree of lower intestinal microbiota disruption at the time of HSCT engraftment has been demonstrated to be an independent predictor (controlling for other markers of underlying disease) of overall and transplant-related 3-year mortality.14 In addition, recent findings suggest that bone marrow suppressive effects of antibiotics, in this case potentially unnecessary oral vancomycin (which is not appreciably absorbed), may be solely mediated via microbiota disruption. All these data supports the notion that antibiotic treatment of NAAT(+), toxin(-) C. difficile patients might have significant negative repercussions without a clear clinical benefit.

Patients will be divided into two groups, one receiving oral vancomycin capsules, the other receiving oral placebo capsules.

The allocation status of patients within this study will be held in sealed envelopes by the unblinded research pharmacist on the team. Neither the main care provider, study physicians, or the patient will know of their group, until either the end of the study (after data analysis). We will also have a blinded pharmacist.

Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients

Randomized Double Blind Controlled Trial for the Treatment of Nucleic Acid Amplification Test (NAAT)+/Toxin Enzyme Immunoassay (EIA)- Clostridium Difficile in the Hematology Oncology Population

Participant data to be shared would consist of age categories, genders, treatment groups, Clostridium difficile status, microbiome profile and metabolic profile. The data will be anonymized to prevent the identification of individual patients from the data provided. The data would be made available through contacting the principal investigator directly.

Changes in Clostridium difficile bacterial counts from stool as determined by quantitative polymerase chain reaction (PCR)

Medical College of Wisconsin

Professor

Neoplasms

Immune System Diseases

Rare Diseases

Lymphoma

Recurrence

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphoid

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Disease Attributes

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Acute Graft Versus Host Disease

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided.

No diet changes will be made for participants

The dietary fiber intake target will be 19 g/d for ages 9-18 and females age 19 and older and 23g/d for males age 19 and older.

Diet Intervention

Catherine Lozupone

The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile infection recurrence in a cohort of oncology patients.

This is a randomized study. A total of 124 individuals with either acute leukemia or lymphoma and a first or second occurrence of C. difficile infection will be enrolled. Participants will be randomized to Arm 1 (Diet intervention) or Arm 2 (No diet intervention). Participants in Arm 1 will be assessed for food preferences and will be provided lists of high fiber and high saturated fats. Participants will be able to choose foods from the high fiber food lists and groceries will be provided once per week to support each participant's meal plan. Participants will be asked to limit foods on the high saturated fats list. Food consumption with a 24 hour recall and weight will be monitored and stool samples will be collected one time per week for 6 weeks. In Arm 2, participants will be asked to provide 24 hour food recall and stool samples. Individuals in both arms will be monitored for stool consistency and any antibiotics or chemotherapy drugs taken. Participation will last 6 weeks.

High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology

Do Decreased Dietary Fat and Increased Fiber Reduce Recurrence of Clostridioides Difficile Infection in Oncology Patients?

Signs of active diarrhea using Bristol stool scale. The Bristol stool form scale includes seven types of stool which ranging from constipation (type 1) to diarrhea (type 7).

Quantify toxins in stool using "Separate detection of C. difficile toxins A and B" kit (tgc Biomics)

Characterize the microbiome in fecal samples as using 16S rRNA targeted and shotgun metagenomic sequencing

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients	NCT03030248	Clostridium Dif... Hematologic Dis... Bone Marrow Tra... Oncologic Disor...	Vancomycin Oral... Placebo Oral Ca...	18 Years -	Medical College of Wisconsin
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology	NCT04940468	Leukemia, Lymph... Leukemia, Myelo... Lymphoma Clostridium Dif...	Diet Interventi...	9 Years -	University of Colorado, Denver
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology	NCT04940468	Leukemia, Lymph... Leukemia, Myelo... Lymphoma Clostridium Dif...	Diet Interventi...	9 Years -	University of Colorado, Denver
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology	NCT04940468	Leukemia, Lymph... Leukemia, Myelo... Lymphoma Clostridium Dif...	Diet Interventi...	9 Years -	University of Colorado, Denver

Spots Global Cancer Trial Database for clostridium difficile infection