Trial | NCT01549782  Report issue

Title

Mixture of Prebiotics on Intestinal Microbiota of Patients Receiving Abdominal Radiotherapy.
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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
Study Started
Jun 30
2005
Primary Completion
Dec 31
2007
Study Completion
Dec 31
2007
Last Update
Mar 09
2012
Estimate

Dietary Supplement Inulin and Fructo-oligosaccharide

6 gr daily of fibre (50% inulin and 50% FOS). Patients underwent a 1-week run-in period before starting RT and continued taking the same products throughout the treatment course, until three weeks after RT was finished.

Dietary Supplement Maltodextrine

6 gr daily of maltodextrine. Patients underwent a 1-week run-in period before starting RT and continued taking the same products throughout the treatment course, until three weeks after RT was finished.

Fiber supplement Active Comparator

6 gr daily of fibre (50% inulin and 50% FOS). Patients underwent a 1-week run-in period before starting RT and continued taking the same products throughout the treatment course, until three weeks after RT was finished.

Maltodextrine Placebo Comparator

6 gr daily of maltodextrine. Patients underwent a 1-week run-in period before starting RT and continued taking the same products throughout the treatment course, until three weeks after RT was finished.

Criteria 

Inclusion Criteria:

female gender, age ≥ 18 years, and a diagnosis of gynaecologic cancer requiring postoperative pelvic RT.

Exclusion Criteria:

previous RT, previous or adjuvant chemotherapy, other types of pelvic tumours or other gynaecologic malignancies, antibiotic or immunosuppressive treatment one week before inclusion or during treatment, and the presence of acute or chronic gastrointestinal disease contraindicating ingestion of the fibre
No Results Posted