Microbiota Clinical Trial
Official title:
Effect of a Mixture of Inulin and Fructo-oligosaccharide on Lactobacillus and Bifidobacterium Intestinal Microbiota of Patients Receiving Radiotherapy: a Randomised, Double-blind, Placebo-controlled Trial.
Abdominal and pelvic radiotherapy (RT) reduces the renewal capacity of the epithelium.
Rectal biopsies obtained from patients receiving pelvic RT have revealed atrophy of surface
epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal
inflammation. Modifications in intestinal microbiota, such as an increase in the number of
pathogens, may contribute to intestinal injury. The prebiotic effect of a carbohydrate is
assessed by its capacity to stimulate the proliferation of healthy bacteria
(Bifidobacterium, Lactobacillus) rather than pathogenic bacteria (Clostridium, E. coli).
The hypothesis of the study is that a mixture of inulin and fructooligosaccharide could
modulate Lactobacillus and Bifidobacterium and reduce the intestinal injury in patients
affected of gynaecological cancer and treated with abdominal radiotherapy.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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