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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01549782
First Posted: March 9, 2012
Last Update Posted: March 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pilar Garci-a Peris, Hospital General Universitario Gregorio Marañon
March 7, 2012
March 9, 2012
March 9, 2012
June 2005
December 2007   (Final data collection date for primary outcome measure)
Changes in Lactobacillus and Bifidobacterium populations [ Time Frame: 2 months ]
Same as current
No Changes Posted
Changes in calprotectin and DNA levels. [ Time Frame: 2 months ]
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
  • Prebiotics
  • Microbiota
  • Radiation Therapy Complication
  • Endometrial Neoplasms
  • 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.
  • Active Comparator: Fiber supplement
    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.
    Intervention: Dietary Supplement: Inulin and Fructo-oligosaccharide
  • Placebo Comparator: 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.
    Intervention: Dietary Supplement: Maltodextrine
García-Peris P, Velasco C, Lozano MA, Moreno Y, Paron L, de la Cuerda C, Bretón I, Camblor M, García-Hernández J, Guarner F, Hernández M. 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. Nutr Hosp. 2012 Nov-Dec;27(6):1908-15. doi: 10.3305/nh.2012.27.6.5992.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2007
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01549782
Prebiotic2005
No
Not Provided
Not Provided
Pilar Garci-a Peris, Hospital General Universitario Gregorio Marañon
Hospital General Universitario Gregorio Marañon
Not Provided
Principal Investigator: Pilar Garcia-Peris, PhD Nutrition Unit. HGU Gregorio Maranon
Hospital General Universitario Gregorio Marañon
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP