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High-Fiber/Low-Fat Diet for C. diff Infection Prevention in Cancer Patients

N/A

Recruiting

Led By Catherine Lozupone

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 9 years or older

Diagnosis of a malignant neoplasm at the Children's Hospital Colorado or the University of Colorado Hospital

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will test whether eating more fiber and less fat can help prevent recurring C. diff infections in cancer patients.

Who is the study for?

This trial is for oncology patients aged 9 or older at Children's Hospital Colorado or the University of Colorado Hospital, diagnosed with acute leukemia or lymphoma and a first-time or recurrent C. difficile infection. Participants must be able to follow the study plan and have specific dietary habits based on a questionnaire.Check my eligibility

What is being tested?

The study aims to see if changing diet by increasing fiber intake and reducing fat can prevent the recurrence of C. difficile infections in cancer patients undergoing treatment.See study design

What are the potential side effects?

Since this is a dietary intervention, side effects may include changes in bowel habits, such as increased gas, bloating, or altered stool consistency due to higher fiber intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 9 years old or older.

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I was diagnosed with cancer at Children's Hospital Colorado or University of Colorado Hospital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

C. difficile infection recurrence (yes/no)

Secondary outcome measures

C. difficile toxins A and B

Fecal microbiome

Trial Design

2Treatment groups

Active Control

Group I: Arm 1: Diet InterventionActive Control1 Intervention

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

Group II: Arm 2: No Diet InterventionActive Control1 Intervention

No diet changes will be made for participants

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,459 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,517 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,269 Previous Clinical Trials

5,481,344 Total Patients Enrolled

Media Library

High-Fiber/Low-Fat Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04940468 — N/A

Clostridium Difficile Infection Research Study Groups: Arm 1: Diet Intervention, Arm 2: No Diet Intervention

Clostridium Difficile Infection Clinical Trial 2023: High-Fiber/Low-Fat Diet Highlights & Side Effects. Trial Name: NCT04940468 — N/A

High-Fiber/Low-Fat Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04940468 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have volunteered to partake in this trial?

"Affirmative. Clinicaltrials.gov reveals that this medical research, initially posted on the 10th of May 2022, is actively recruiting for participants. A total of 124 volunteers must be recruited from two distinct locations."

Answered by AI

Are there any available openings for participants in this study?

"Affirmatively, this research is still seeking enrolment. The trial was first posted on May 10th 2022 and its details were most recently adjusted on June 29th 2022 according to clinicaltrials.gov's records."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04940468.

All > Acute Myeloid Leukemia > Aml