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

Cancer Clinical Trial

— RTxIMprobio  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01706393
• Other study ID #: SNUH-Cell-01
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2012
• Last updated: April 18, 2013
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2013
• Source: Seoul National University Hospital
• Contact: Hak Jae Kim, MD
• Phone: +82-2-2072-2520
• Email: khjae[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No