Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Pts(Get Pelvic/Abdominal Rtx) (RTxIMprobio)
This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 June 17, 2013