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

Primary Purpose

Prebiotics, Microbiota, Radiation Therapy Complication

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inulin and Fructo-oligosaccharide
Maltodextrine
Sponsored by
Hospital General Universitario Gregorio Marañon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prebiotics focused on measuring Prebiotics, Microbiota, Radiotherapy, Gynaecological Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nutrition Unit. HGU Gregorio Marañón

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fiber supplement

Maltodextrine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in Lactobacillus and Bifidobacterium populations

Secondary Outcome Measures

Changes in calprotectin and DNA levels.

Full Information

First Posted
March 7, 2012
Last Updated
March 8, 2012
Sponsor
Hospital General Universitario Gregorio Marañon
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1. Study Identification

Unique Protocol Identification Number
NCT01549782
Brief Title
Mixture of Prebiotics on Intestinal Microbiota of Patients Receiving Abdominal Radiotherapy.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Gregorio Marañon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prebiotics, Microbiota, Radiation Therapy Complication, Endometrial Neoplasms
Keywords
Prebiotics, Microbiota, Radiotherapy, Gynaecological Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fiber supplement
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Maltodextrine
Arm Type
Placebo Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Inulin and Fructo-oligosaccharide
Intervention Description
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 Type
Dietary Supplement
Intervention Name(s)
Maltodextrine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Lactobacillus and Bifidobacterium populations
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Changes in calprotectin and DNA levels.
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Garcia-Peris, PhD
Organizational Affiliation
Nutrition Unit. HGU Gregorio Maranon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutrition Unit. HGU Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23588438
Citation
Garcia-Peris P, Velasco C, Lozano MA, Moreno Y, Paron L, de la Cuerda C, Breton I, Camblor M, Garcia-Hernandez J, Guarner F, Hernandez 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.
Results Reference
derived

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

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