Post-operative Ileus and Gut Microbiota

NCT04009954 | Unknown

• 1 other identifier: Yunwei Wei 2019-04-19
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative ileus (POI) is a common clinical condition after abdominal surgical procedure, leading to increased patient morbidity and prolonged hospitalisation.The mechanism of POI is not very clear until now. At the end of the 20th century, the inflammatory-mediated ileus hypothesis was introduced. But the initial trigger of the inflammatory cascade is unclear.Previous study demonstrate a clear association between colonic transit time, gut microbiota composition and urinary metabolic phenotype. Here the investigators suggest that the perioperative gut microbiota may contribute to POI.

Conditions

Post-operative Ileus

Keywords

Post-operative Ileus; Gut Microbiota; perioperative period

Outcome Measures

Primary Outcomes (2)

• Change in gut microbiome dynamics in colorectal cancer patients during the perioperative period between two groups

  The diversity, structure of fecal microbiota and relative abundance of special bacterial taxa 16S rRNA gene sequencing will be performed.

  The day before operation day, the first to the 10th day after operation (everyday the patient's faeces will be collected for microbiome analysis, if the patient has no faeces,we will skip that day to next day for fecal collection)

• The time ranging from operation day to the day of first defecation

  The recovery of gut transit can be indicated by the first defecation

  Up to 10 days

Secondary Outcomes (4)

• Concentration of plasma i-FABP(intestinal fatty acid-binding protein)

  The day before operation day, every day from first to fifth post-operative day

• Concentration of plasma LPS

  The day before operation day, every day from first to fifth post-operative day

• Concentration of fecal LPS

  The day before operation day, the first to the 10th day after operation (everyday the patient's faeces will be collected for microbiome analysis, if the patient has no faeces,we will skip that day to next day for fecal collection)

• Concentration of fecal calprotectin

  The day before operation day, the first to the 10th day after operation (everyday the patient's faeces will be collected for microbiome analysis, if the patient has no faeces,we will skip that day to next day for fecal collection)

Study Arms (2)

Delayed transit

CRC patients with delayed gut transit recovery( first time defecation \>3 day )

Other: Fecal and blood samples collection for analysis

Normal transit

CRC patients with normal gut transit recovery( first time defecation \<=3 day )

Other: Fecal and blood samples collection for analysis

Interventions

Fecal and blood samples collection for analysis OTHER

Fecal sample analysis will consist of the following procedure : Microbial DNA extraction, amplicon library construction, sequencing and analysis; Clustering "MiSeq" reads into operational taxonomic units (OTUs).

Delayed transit; Normal transit

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants are patients need undergo an exhaustive colorectal cancer surgical resection in the First Affiliated Hospital of Harbin Medical University from May 1, 2018 to Dec 31, 2019.

You may qualify if:

• Requirements of informed consent and assent of participant, parent or legal guardian as applicable
• Patients with colorectal cancer scheduled for radical coloproctectomy and between the age of 35 and 80 years old without considering sex.
• Patients with BMI= 18.5-23.9

You may not qualify if:

• Patients with colorectal cancer with distant metastasis
• Chronic renal diseases and hepatic cirrhosis
• Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months
• Individuals with a history of Chronic diarrhea
• Individuals with a history of Diabetes mellitus
• Individuals with a history of Hypertension
• Individuals with a history of autoimmune diseases
• Use of antibiotics and probiotics 3 mouth before samples collection
• Individuals with a history of abdominal operation due to any reason
• Individuals with any history of cancer other than colorectal cancer
• Individuals with Inflammatory bowel disease

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal sample analysis will consist of the following procedure : Microbial DNA extraction, amplicon library construction, sequencing and analysis; Clustering "MiSeq" reads into operational taxonomic units (OTUs).

MeSH Terms

Interventions

Defecation

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Yunwei Wei

  First Affiliated Hospital of Harbin Medical University

  STUDY DIRECTOR

Central Study Contacts

Yunwei Wei, professor

CONTACT

+86045185553099; hydwyw11@hotmail.com

Yang Liu, assistant research fellow

CONTACT

+8618345180169; lyang712@icloud.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: July 8, 2019
• Study Start: April 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: July 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)