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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA046934 | U.S. NIH Grant/Contract | View source | |
| U01AI150589-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Diet Intervention | Active Comparator | Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided. |
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| Arm 2: No Diet Intervention | No Intervention | No diet changes will be made for participants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet Intervention | Other | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| C. difficile infection recurrence (yes/no) | 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| C. difficile toxins A and B | Quantify toxins in stool using "Separate detection of C. difficile toxins A and B" kit (tgc Biomics) | 6 weeks |
| Fecal microbiome | Characterize the microbiome in fecal samples as using 16S rRNA targeted and shotgun metagenomic sequencing |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Lozupone | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| University of Colorado Hospital |
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| 6 weeks |
| Aurora |
| Colorado |
| 80045 |
| United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D008223 | Lymphoma |
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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