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

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ClinicalTrials.gov Identifier: NCT01706393
Recruitment Status : Unknown
Verified April 2013 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : October 15, 2012
Last Update Posted : April 19, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cancer 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013
Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy. [ Time Frame: 42 days ]
    • 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 :
  1. Prevention of any grade of diarrhea and gastrointestinal symptoms [ Time Frame: 42 days ]
    • 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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706393

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

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

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01706393     History of Changes
Other Study ID Numbers: SNUH-Cell-01
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013

Keywords provided by Seoul National University Hospital:
intestinal microbiome