An interventional study of Soluble Corn Fiber and Maltodextrin in Rectal Cancer, sponsored by Ochsner Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by Ochsner Health System · Not applicable, Interventional, and Other
A significant racial disparity in the incidence and mortality of CRC exists in the U.S. with African Americans having CRC incidence and mortality rates that are 20% and 40% higher than the general U.S. population. It has been demonstrated that the gut microbiome impacts tumor development and progression through multiple mechanisms, including impacting the tumoral immune response. However, it is unknown if microbiome modulating treatment can have an impact on CRC outcomes.
A significant racial disparity in the incidence and mortality of CRC exists in the U.S. with African Americans having CRC incidence and mortality rates that are 20% and 40% higher than the general U.S. population. It has been demonstrated that the gut microbiome impacts tumor development and progression through multiple mechanisms, including impacting the tumoral immune response. However, it is unknown if microbiome modulating treatment can have an impact on CRC outcomes.
This is a pilot project to see if any changes are detected in stool and/or tissue samples in rectal cancer patients who receive a soluble corn fiber supplement during their neoadjuvant treatment.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 20 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Ochsner Health System is the lead sponsor of 54 studies on the registry; 7 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Soluble Corn Fiber
Dietary Supplement: Soluble Corn Fiber
Maltodextrin
Dietary Supplement: Maltodextrin
once daily additive to diet
once daily additive to diet
Gut Flora modulation
fiber supplements with prebiotic effects modulate the gut and tumor associated microbiome leading to improved outcomes in stage II and III rectal cancer patients
Time frame: 1 year
Microbiome changes
To characterize the changes in the gut and tumor associated microbiome
Time frame: 6 months
Immune Profile
To evaluate the impact of prebiotic fiber treatment and microbiome changes on the tumor immune profile known to be associated with favorable outcomes
Time frame: 6 months
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Ochsner Health System