NCT02169388.

Trial name or title	Effects of gut microflora on the immune and nutritional status of CRC patients after chemotherapy
Methods	Allocation: randomised Endpoint classification: efficacy study Intervention model: parallel assignment Masking: double‐blind (subject, caregiver, investigator) Primary purpose: supportive care
Participants	Estimated enrolment: 30 Ages eligible for study: 18 to 80 years (adult, senior) Genders eligible for study: both Accepts healthy volunteers: no Inclusion criteria: Scheduled for chemotherapy after radical resection of colorectal cancer Exclusion criteria: Palliative resection of colorectal cancer Antibiotic, probiotic, or prebiotic usage within 1 month Other malignancy History of other abdominal surgery Coagulopathy or bleeding disorders Pregnant or breast‐feeding (for females) Impaired liver or renal function
Interventions	Experimental: probiotic (microbial composition using probiotic, 3 capsules/times, 2 times/d for 4 weeks) Placebo comparator: placebo (Microbiota modulation using placebo, 3 capsules/times, 2 times/d for 4 weeks)
Outcomes	Primary outcome measures: Composition of micro‐organisms in stool after probiotic intervention [Time Frame: 5 months] [Designated as safety issue: No] Primary coordination of faecal samples: 16s rDNA (ribosomal DNA) will be compared between 2 groups using Bray‐Curtis distance‐based primary co‐ordination analysis (PCoA) Short‐chain fatty acids in faeces of patients after chemotherapy [Time Frame: 5 months] [Designated as safety issue: No] The total concentration of short‐chain fatty acids in the faeces of patients after chemotherapy Frequency and severity of adverse effects during chemotherapy [Time Frame: 5 months] [Designated as safety issue: No] Adverse effects include vomiting, nausea, diarrhoea, and abdominal pain Secondary outcome measures: Observed changes in immune status after chemotherapy [Time Frame: 5 months] [Designated as safety issue: No] Immune status indexes include percentage of neutrophils, total lymphocytes, lymphocyte subgroups, plasma immunoglobulin level, CRP (C‐reactive protein) Observed changes in nutritional status after chemotherapy [Time Frame: 5 months] [Designated as safety issue: No] Nutritional status indexes include BMI, percentage of body weight changes, plasma albumin, and prealbumin
Starting date	ClinicalTrials.gov Identifier: NCT02169388 Study start date: June 2014 Estimated primary completion date: January 2015
Contact information	Contact: Yanqing Li, MD, PhD; 86‐531‐82169236 ext 82169508; liyanqing@sdu.edu.cn
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