Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Pts(Get Pelvic/Abdominal Rtx)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to evaluate the effect of probiotics to improve the intestinal microbiome in malignancy patients who get pelvic/abdominal radiotherapy.

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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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probiotics

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 Type EXPERIMENTAL

probiotics (six probiotic cultures)

Intervention Type DIETARY_SUPPLEMENT

Effects of probiotics supplementation on intestinal microbiome; 2capsule bid orally for six weeks, 1capsule(500mg) Started eating probiotics one week prior of radiation therapy.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.

Interventions

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probiotics (six probiotic cultures)

Effects of probiotics supplementation on intestinal microbiome; 2capsule bid orally for six weeks, 1capsule(500mg) Started eating probiotics one week prior of radiation therapy.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.
* ECOG performance status (PS) of 0, 1, or 2.
* signed written informed consent.
* Patients who get pelvic/abdominal radiotherapy.

Exclusion Criteria

* People who use antibiotics that can affect intestinal microorganism growth within one month before the study.
* Patients who use probiotics within one month before the study.
* Patients received neoadjuvant chemotherapy.
* Acute enteritis symptoms (diarrhea, abdominal pain, nausea, vomiting) for the patient.
* Patients diagnosed with inflammatory bowel disease.
* Patients suspected gastrointestinal infections and other infectious diseases.
* Suspected infections from blood tests : Excessive rise in WBC, ESR, CRP
* Suspected renal insufficiency from blood tests

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No