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Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.

NCT01414517 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2011-08-11

No results posted yet for this study

Summary

The study will consist of pair of double-blind placebo-controlled trials of dietary supplementation with 15g/day FructoOligoSaccharide (FOS) for 7.5 weeks in patients with prostate carcinoma or 5 weeks in patients with cervical or endometrial carcinoma who are to undergo pelvic radiotherapy with intent to cure.

Conditions

  • Radiation Enteritis
  • Radiation Proctitis

Interventions

DIETARY_SUPPLEMENT

FructoOligoSaccharide

A mixture of 70% oligofructose and 30% inulin.

DIETARY_SUPPLEMENT

Maltodextrin

a non-prebiotic carbohydrate

Sponsors & Collaborators

  • University College London Hospitals

    lead OTHER

Principal Investigators

  • Alastair Forbes, Bsc;MD;FRCP;FHEA · University College London Hospitals/University College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01414517 on ClinicalTrials.gov