Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy
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|ClinicalTrials.gov Identifier: NCT02169388|
Recruitment Status : Unknown
Verified June 2014 by Yanqing Li, Shandong University.
Recruitment status was: Recruiting
First Posted : June 23, 2014
Last Update Posted : June 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Neoplasms Colorectal Cancer Effects of Chemotherapy Tumor Immunity Malnutrition||Drug: Probiotic Drug: placebo（for probiotic）||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Gut Microflora on the Immune and Nutritional Status of CRC Patients After Chemotherapy|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||January 2015|
Microbial composition using Probiotic，3 capsules / times, 2 times / day for 4 weeks
Microbial composition using probiotic
Placebo Comparator: placebo
Microbiota modulation using placebo，3 capsules / times, 2 times / day for 4 weeks
Drug: placebo（for probiotic）
microbiota modulation using placebo
- Composition of Microorganisms in stool after probiotic intervention [ Time Frame: 5 months ]Primary coordination of fecal samples' 16s rDNA (ribosomal DNA) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).
- Short-chain fatty acids in feces of patients after chemotherapy [ Time Frame: 5 months ]The total concentration of Short-chain fatty acids in the in feces of patients after chemotherapy.
- Frequency and severity of Adverse effects during Chemotherapy [ Time Frame: 5 months ]Adverse effects includes vomiting, nausea, diarrhea and abdominal pain.
- The observed changes in immune status after chemotherapy [ Time Frame: 5 month ]Immune status indexes include percentage of Neutrophils, total lymphocytes, lymphocyte subgroups, plasma immunoglobulin level, CRP (C reactive protein).
- The observed changes in nutritional status after chemotherapy [ Time Frame: 5 months ]Nutritional status indexes include BMI, percentage of body weight changes, plasma albumin and prealbumin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169388
|Contact: Yanqing Li, MD.PhD.||86-531-82169236 ext firstname.lastname@example.org|
|Department of Gastroenterology,Qilu Hospital,Shandong University||Recruiting|
|Jinan, Shandong, China, 250012|
|Contact: Yanqing Li, MD.PhD. 86-531-82169236 ext 82169508 email@example.com|
|Principal Investigator: Yanqing Li, MD.PhD.|
|Sub-Investigator: Ming Li, MD|
|Sub-Investigator: Yang Tian, MD|
|Principal Investigator:||Yanqing Li, MD.PhD||Qilu Hospital，Shandong University|