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

March 8, 2012 updated by: Pilar Garci-a Peris, Hospital General Universitario Gregorio Marañon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Nutrition Unit. HGU Gregorio Marañón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Lactobacillus and Bifidobacterium populations
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in calprotectin and DNA levels.
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Investigators

  • Principal Investigator: Pilar Garcia-Peris, PhD, Nutrition Unit. HGU Gregorio Marañón

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prebiotic2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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