Diet intervention
OtherThe 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.
NCT Number: NCT04940468
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.
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Notify Me9 year and older
All sexes
Interventional
Not applicable
Childrens Hospital Colorado, Aurora, Colorado, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Time frame: 6 months
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 weeks
Quantify toxins in stool using "Separate detection of C. difficile toxins A and B" kit (tgc Biomics)
Time frame: 6 weeks
Characterize the microbiome in fecal samples as using 16S rRNA targeted and shotgun metagenomic sequencing
University of Colorado, Denver
Other
Do Decreased Dietary Fat and Increased Fiber Reduce Recurrence of Clostridioides Difficile Infection in Oncology Patients?
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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