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Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms

NCT01901042 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-07-17

No results posted yet for this study

Summary

Radiation proctitis is quite common in treatment of pelvic tumors. We investigated whether the use of symbiotic would prevent early symptoms of radiation proctitis and improve the quality of life in patients undergoing radiotherapy for prostate cancer treatment. We randomized patients to intake one sachet of either a symbiotic product containing 4.3 g of dietary fiber and Lactobacillus reuteri in a concentration greater than 10(8)colony forming units (CFU)(Fibermais Flora Nestlé Brazil) or sachets containing 5 g of maltodextrin. They were instructed to dilute one sachet in 200mL of water and drink once a day during the week before the beginning of radiotherapy sessions, and increase the dose to two sachets daily after the beginning of the sessions for four weeks. Every week a questionnaire named EORTC QLQ-PRT23 was applied to evaluate GI symptoms and quality of life.

Conditions

Interventions

DIETARY_SUPPLEMENT

Symbiotic

Sachets with a symbiotic product in powder form containing 4.3 g of dietary fiber and Lactobacillus reuteri in a concentration greater than 1.0 x 108 colony forming units (CFU), with five grams per sachet (Fibermais Flora Nestlé Brazil).

DIETARY_SUPPLEMENT

Maltodextrin

Control patients will receive sachets containing maltodextrin

Sponsors & Collaborators

  • Federal University of Mato Grosso

    lead OTHER

Principal Investigators

  • JOSE E AGUILAR-NASCIMENTO, MD, PhD · Federal University of Mato Grosso

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-11-30
Completion
2012-11-30

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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 NCT01901042 on ClinicalTrials.gov