Suspended

RTxIMprobioDouble Blind Placebo Controled Randomized Trial, Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Patients Who Get Pelvic/Abdominal Radiotherapy

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What is being tested

probiotics (six probiotic cultures)

+ Placebo

Dietary Supplement
Who is being recruted

Neoplasms

From 18 to 75 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorSeoul National University Hospital
Study ContactHak Jae Kim, MDMore contacts
Last updated: April 19, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

Pelvic/abdominal radiotherapy carries a risk of complications. Acute complications include diarrhea, abdominal pain, inflammatory change in the small intestine. Radiation creates changes in bacterial microbiome, the vascular permeability of the mucosal cells and in intestinal motility. Probiotics were known to improve gastrointestinal function. This is a randomized, double-blind, placebo-controlled study involving 26 patients designed to evaluate the effect of probiotics to change the intestinal microbiome in in patients undergoing concurrent pelvic/abdominal RT.

NCT01706393
Principal SponsorSeoul National University Hospital
Study ContactHak Jae Kim, MDMore contacts
Last updated: April 19, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

4 inclusion criteria required to participate
ECOG performance status (PS) of 0, 1, or 2
Patients who current diagnosis of gynecologic cancer or rectal cancer and never previously received radiation therapy and will use for the first time radiotherapy at department of radiation oncology, Seoul National University Hospital
Patients who get pelvic/abdominal radiotherapy
signed written informed consent
8 exclusion criteria prevent from participating
Acute enteritis symptoms (diarrhea, abdominal pain, nausea, vomiting) for the patient
Patients diagnosed with inflammatory bowel disease
Patients received neoadjuvant chemotherapy
Patients suspected gastrointestinal infections and other infectious diseases
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Probiotics supplementation group. Probiotics intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day. Probiotics is composed of Lactobacillus acidophilus, Streptococcus thermophilus, Bifidobacterium lactis, L. rhamnosus, B. longum and B. bifidum.

Group II

Placebo
Placebo group. Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day. Placebo is composed of starch.Probiotics and placebo were similar in appearance, taste.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Seoul National University Hospital

Seoul, South KoreaOpen Seoul National University Hospital in Google Maps
SuspendedOne Study Center