Clostridium Difficile Infection, Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Acute, Lymphoma, Solid Cancers
Conditions
Brief summary
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.
Detailed description
This is a randomized study. A total of 124 individuals with cancer 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 foods with 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.
Interventions
OTHERDiet Intervention
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.
Sponsors
University of Colorado, Denver
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of a malignant neoplasm at the at Children's Hospital Colorado or the University of Colorado Hospital * Diagnosis of first time or first recurrent CDI as defined by clinical criteria within the past 21 days * Informed consent obtained and signed. For minors, the consent will be completed by a guardian and the study participant will sign the assent form. Only the consent form is required of adults. * 9 years old or older * 40th to 100th percentiles of saturated fat intake and below the 50th percentile for fiber intake based on a food frequency questionnaire. * Ability to comply with study procedures for the entire length of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrent C Difficile Infection | 6 weeks | Clinical diagnosis of recurrent C. difficile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C. Difficile Toxins A and B | 6 weeks | Quantify toxins in stool using "Separate detection of C. difficile toxins A and B" kit (tgc Biomics) |
| Fecal Microbiome | 6 weeks | Characterize the microbiome in fecal samples as using 16S rRNA targeted and shotgun metagenomic sequencing |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCatherine Lozupone
University of Colorado, Denver
Participant flow
Recruitment details
Study patients were all oncology patients with a diagnosis of a malignant neoplasm at Children's Hospital Colorado and University of Colorado Hospital. A simple randomization procedure with stratification was used to assign study participants to the diet intervention or control arm. Study participants were recruited through clinical providers within inpatient and outpatient settings, including at the UCHealth Clinical Assessment and Rapid Evaluation (CARE) clinic at Anschutz.
Pre-assignment details
Enrollment was challenging and we did not meet our targets despite expanding efforts to engage with medical providers and use enhanced screening tools. Individuals with both cancer and C. difficile often had very complex medical profiles that made participation in diet intervention challenging. Almost half who did show interest and were confirmed as eligible by their medical provider did not meet the dietary entry criteria of currently consuming a relatively high fat and low fiber diet.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 16 years |
| Cancer type Hematologic | 4 number of participants |
| Cancer type Solid tumor | 0 number of participants |
| Disease Status Refractory | 4 Number of participants |
| Disease Status Remission | 1 Number of participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 5 |
| other Total, other adverse events | 3 / 3 | 5 / 5 |
| serious Total, serious adverse events | 2 / 3 | 2 / 5 |
Outcome results
None listed