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

18 Years
75 Years
Open (Enrolling)

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Outcome Measure:

Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy.

Outcome Description:

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.

Outcome Time Frame:

42 days

Safety Issue:


Principal Investigator

Hak Jae Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


South Korea: Institutional Review Board

Study ID:




Start Date:

October 2012

Completion Date:

July 2013

Related Keywords:

  • Cancer
  • probiotics
  • intestinal microbiome
  • radiotherapy