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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Dietary supplement: probiotics (six probiotic cultures); Dietary supplement: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.
Placebo Comparator: 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.	Dietary supplement: Placebo; Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy.	Comparison of overall microbial communities in fecal samples between probiotics treated patients and control cancer patients receiving radiation therapy.; To determine preventing effect of probiotics against radiation enteropathy, all the bacterial species level taxon derived from fecal samples of cancer patients will be identified by massive sequencing analysis and relative abundance of each taxon between two groups will be statistically compared.; In addition, overall microbial composition, kind of species and their abundance, in two groups will be compared with clustering method such as UPGMA and PCoA and the variation values between two groups will be calculated.; In the current study, we will determine the effectiveness of probiotics for the prevention of radiation induced complications with these two comparative analysis methods.	42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of any grade of diarrhea and gastrointestinal symptoms	Gastrointestinal symptoms will be scored according the Gastrointestinal symptom rating scale before and after RTx.; Diarrhea will be graded weekly according the Common Toxicity Criteria system.	42 days

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hak Jae Kim, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: August 31, 2012
• First Submitted That Met QC Criteria: October 11, 2012
• First Posted (Estimate): October 15, 2012

Study Record Updates

• Last Update Posted (Estimate): April 19, 2013
• Last Update Submitted That Met QC Criteria: April 18, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: radiotherapy; probiotics; intestinal microbiome
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SNUH-Cell-01