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Probiotics modulate the gut microflora and immune status in CRC,which can reduce the side effects of chemotherapy such as diarrhea,infection,neutropenia etc.
Chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing bacterial translocation, infection and other complications; Probiotics may restore the intestinal immunity, mucosal barrier, and nutrient absorption.The adverse effects of chemotherapy and the malnutrition status may be relieved via probiotic administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Microbial composition using Probiotic，3 capsules / times, 2 times / day for 4 weeks |
|
| placebo | Placebo Comparator | Microbiota modulation using placebo，3 capsules / times, 2 times / day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Drug | Microbial composition using probiotic |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The observed changes in immune status after chemotherapy | Immune status indexes include percentage of Neutrophils, total lymphocytes, lymphocyte subgroups, plasma immunoglobulin level, CRP (C reactive protein). | 5 month |
| The observed changes in nutritional status after chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanqing Li, MD.PhD. | Contact | 86-531-82169236 | 82169508 | liyanqing@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanqing Li, MD.PhD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology,Qilu Hospital,Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| C064918 | phosphatidyltransferase, Clostridium butyricum |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| placebo（for probiotic） | Drug | microbiota modulation using placebo |
|
Nutritional status indexes include BMI, percentage of body weight changes, plasma albumin and prealbumin. |
| 5 months |
| D005767 |
| Gastrointestinal Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D019602 |
| Food and Beverages |