Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy

NCT02169388 | Unknown Phase 1 DMC

• 1 other identifier: 2014SDU-QILU-G03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Probiotics modulate the gut microflora and immune status in CRC,which can reduce the side effects of chemotherapy such as diarrhea,infection,neutropenia etc.

Conditions

Gastrointestinal Neoplasms; Colorectal Cancer; Effects of Chemotherapy; Tumor Immunity; Malnutrition

Keywords

Gut microflora; colorectal cancer; Chemotherapy; Immunity; Nutrition

Outcome Measures

Primary Outcomes (3)

• Composition of Microorganisms in stool after probiotic intervention

  Primary coordination of fecal samples' 16s rDNA (ribosomal DNA) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).

  5 months

• Short-chain fatty acids in feces of patients after chemotherapy

  The total concentration of Short-chain fatty acids in the in feces of patients after chemotherapy.

  5 months

• Frequency and severity of Adverse effects during Chemotherapy

  Adverse effects includes vomiting, nausea, diarrhea and abdominal pain.

  5 months

Secondary Outcomes (2)

• The observed changes in immune status after chemotherapy

  5 month

• The observed changes in nutritional status after chemotherapy

  5 months

Study Arms (2)

Probiotic

EXPERIMENTAL

Microbial composition using Probiotic，3 capsules / times, 2 times / day for 4 weeks

Drug: Probiotic

placebo

PLACEBO COMPARATOR

Microbiota modulation using placebo，3 capsules / times, 2 times / day for 4 weeks

Drug: placebo（for probiotic）

Interventions

Probiotic DRUG

Microbial composition using probiotic

Also known as: containing, （ clostridium butyricum）

Probiotic

placebo（for probiotic） DRUG

microbiota modulation using placebo

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for chemotherapy after radical resection of colorectal cancer

You may not qualify if:

• Palliative resection of colorectal cancer
• Antibiotic,probiotic or prebiotic usage within 1months
• Other malignancy
• History of other abdominal surgery
• Coagulopathy or bleeding disorders
• Pregnant or breast-feeding(for females)
• Impaired liver or renal function

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Colorectal Neoplasms; Malnutrition

Interventions

Probiotics; phosphatidyltransferase, Clostridium butyricum

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Yanqing Li, MD.PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li, MD.PhD.

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

CN (1)