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

Primary Purpose

Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Acute, Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet Intervention
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Leukemia, Lymphocytic, Acute

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of acute lymphocytic or myelocytic leukemia or lymphoma 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 7 days
  • Informed consent and assent obtained and signed.
  • At least 9 years old.
  • 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.

Sites / Locations

  • Childrens Hospital ColoradoRecruiting
  • University of Colorado HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm 1: Diet Intervention

Arm 2: No Diet Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

C. difficile toxins A and B
Quantify toxins in stool using "Separate detection of C. difficile toxins A and B" kit (tgc Biomics)
Fecal microbiome
Characterize the microbiome in fecal samples as using 16S rRNA targeted and shotgun metagenomic sequencing

Full Information

First Posted
June 17, 2021
Last Updated
June 30, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT04940468
Brief Title
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology
Official Title
Do Decreased Dietary Fat and Increased Fiber Reduce Recurrence of Clostridioides Difficile Infection in Oncology Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2022 (Actual)
Primary Completion Date
December 18, 2024 (Anticipated)
Study Completion Date
December 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Acute, Lymphoma, Clostridium Difficile Infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Diet Intervention
Arm Type
Active Comparator
Arm Description
Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided.
Arm Title
Arm 2: No Diet Intervention
Arm Type
No Intervention
Arm Description
No diet changes will be made for participants
Intervention Type
Other
Intervention Name(s)
Diet Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
C. difficile infection recurrence (yes/no)
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
C. difficile toxins A and B
Description
Quantify toxins in stool using "Separate detection of C. difficile toxins A and B" kit (tgc Biomics)
Time Frame
6 weeks
Title
Fecal microbiome
Description
Characterize the microbiome in fecal samples as using 16S rRNA targeted and shotgun metagenomic sequencing
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of acute lymphocytic or myelocytic leukemia or lymphoma 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 7 days Informed consent and assent obtained and signed. At least 9 years old. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Lozupone
Phone
303-724-7942
Email
Catherine.Lozupone@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Lozupone
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Lozupone
Phone
303-724-7942
Email
catherine.lozupone@cuanschutz.edu
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Lozupone
Phone
303-724-7942
Email
catherine.lozupone@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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