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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01706393
First received: August 31, 2012
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Cancer
Dietary Supplement: probiotics (six probiotic cultures)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Double Blind Placebo Controled Randomized Trial, Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Patients Who Get Pelvic/Abdominal Radiotherapy

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy. [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    • 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.


Secondary Outcome Measures:
  • Prevention of any grade of diarrhea and gastrointestinal symptoms [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 26
Study Start Date: October 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706393

Contacts
Contact: Hak Jae Kim, MD +82-2-2072-2520 khjae@snu.ac.kr
Contact: Seung Wan Kang, MD,PhD +82-2-747-7422 drdemian@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hak Jae Kim, MD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01706393     History of Changes
Other Study ID Numbers: SNUH-Cell-01
Study First Received: August 31, 2012
Last Updated: April 18, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
probiotics
intestinal microbiome
radiotherapy

ClinicalTrials.gov processed this record on September 18, 2014