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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pilar Garci-a Peris, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:
NCT01549782
First received: March 7, 2012
Last updated: March 8, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Prebiotics
Microbiota
Radiation Therapy Complication
Endometrial Neoplasms
 Dietary Supplement: Inulin and Fructo-oligosaccharide
Dietary Supplement: Maltodextrine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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.

Resource links provided by NLM:

Drug Information available for: Inulin
U.S. FDA Resources

Further study details as provided by Hospital General Universitario Gregorio Marañon:

Primary Outcome Measures:
  • Changes in Lactobacillus and Bifidobacterium populations [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in calprotectin and DNA levels. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549782

Locations
Spain
Nutrition Unit. HGU Gregorio Marañón
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Investigators
Principal Investigator: Pilar Garcia-Peris, PhD Nutrition Unit. HGU Gregorio Maranon
  More Information

No publications provided by Hospital General Universitario Gregorio Marañon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pilar Garci-a Peris, Endocrinologist., Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT01549782     History of Changes
Other Study ID Numbers: Prebiotic2005
Study First Received: March 7, 2012
Last Updated: March 8, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Hospital General Universitario Gregorio Marañon:
Prebiotics
Microbiota
Radiotherapy
Gynaecological Cancer

Additional relevant MeSH terms:
Neoplasms
Endometrial Neoplasms
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on June 18, 2013