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

NCT01706393 | Unknown DMC

• 1 other identifier: SNUH-Cell-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

probiotics; intestinal microbiome; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Prevention of any grade of diarrhea and gastrointestinal symptoms

  42 days

Study Arms (2)

probiotics

EXPERIMENTAL

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)

placebo

PLACEBO COMPARATOR

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

Interventions

probiotics (six probiotic cultures) DIETARY_SUPPLEMENT

Effects of probiotics supplementation on intestinal microbiome; 2capsule bid orally for six weeks, 1capsule(500mg) Started eating probiotics one week prior of radiation therapy.

probiotics

Placebo DIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hak Jae Kim, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hak Jae Kim, MD

CONTACT

+82-2-2072-2520; khjae@snu.ac.kr

Seung Wan Kang, MD,PhD

CONTACT

+82-2-747-7422; drdemian@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

KR (1)