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.
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Prebiotics, Microbiota, Radiation Therapy Complication, Endometrial Neoplasms
Female
Prebiotics, Microbiota, Radiation Therapy Complication, Endometrial Neoplasms
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
Changes in Lactobacillus and Bifidobacterium populations
Outcome Time Frame:
2 months
Safety Issue:
No
Principal Investigator
Pilar Garcia-Peris, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Nutrition Unit. HGU Gregorio Maranon
Authority:
Spain: Ministry of Health
Study ID:
Prebiotic2005
NCT ID:
NCT01549782
Start Date:
June 2005
Completion Date:
December 2007
Related Keywords:
- Prebiotics
- Microbiota
- Radiation Therapy Complication
- Endometrial Neoplasms
- Prebiotics
- Microbiota
- Radiotherapy
- Gynaecological Cancer
- Neoplasms
- Endometrial Neoplasms
- Adenoma
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