Effect of Carbon Dioxide Insufflation and Appendix on the Restoration of Intestinal Microecology After Colonoscopy.

NCT05637021 | Unknown

• 1 other identifier: 2022-014
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about Influencing factors of intestinal microecological changes before and after colonoscopy. The main questions it aims to answer are:

• \[question 1\] The process of colonoscopic gas insufflation affects the intestinal microecology. Will the use of carbon dioxide gas insufflation can reduce the changes of intestinal microecology after colonoscopy?
• \[question 2\] Can the appendix act as a reservoir for microorganisms to accelerate the recovery of intestinal microecology after colonoscopy？ Participants will be asked to accept colonoscopy for once. Group 1(Control group) will be insufflated air during the colonoscopy; Group 2(Carbon dioxide group) will be insufflated carbon dioxide during the colonoscopy; Group 3(After appendectomy group) will be insufflated air during the colonoscopy. Since Group 1 is comparison group, the investigators will compare Group 2 to see if carbon dioxide gas insufflation can reduce the changes of intestinal microecology after colonoscopy. Meanwhile, compare Group 3 to see if the appendix can accelerate the recovery of intestinal microecology after colonoscopy.

Conditions

Colonoscopy; Gastrointestinal Microbiome; Appendix; Carbon Dioxide Insufflation

Outcome Measures

Primary Outcomes (1)

• The intestinal microbiota composition

  Changes in the intestinal microbiome are observed by detecting the feces at the specific time point.Then, factors affecting the recovery of the intestinal microbiome are assessed based on their changes.

  Before bowel cleansing, after colonoscopy, 7、14 and 28 days after the treatment

Study Arms (3)

Control group

Healthy people were randomly divided into CO2 group and control group, with 20 cases in each group. After bowel preparation, volunteers underwent colonoscopy, with air routinely insufflated into the control group during colonoscopy.

Carbon dioxide group

Healthy people were randomly divided into CO2 group and control group, with 20 cases in each group. After bowel preparation, volunteers underwent colonoscopy, with CO2 insufflated into the control group during colonoscopy.

Other: Carbon dioxide insufflated during colonoscopy

After appendectomy group

Volunteers after appendectomy were included in the appendectomy group. After bowel preparation, all volunteers underwent colonoscopy, air routinely insufflated into the appendectomy group.

Interventions

Carbon dioxide insufflated during colonoscopy OTHER

Carbon dioxide is insufflated to dilate the bowel lumen during colonoscopy.Record the amount of gas insufflated during colonoscopy.

Carbon dioxide group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The patients in the after appendectomy group were patients who underwent appendectomy in the Department of General Surgery, Zhongshan Hospital Xiamen University within 3 years. The other volunteers are residents of Xiamen City.

You may qualify if:

• Age 18-40 years old, gender is not limited, no underlying diseases;
• BMI between 18.5-23.9 kg/m2;
• Fecal Bristol score type III-IV in the past week;
• No history of alcohol consumption or alcohol consumption equivalent to ethanol should not exceed 140g per week for men and 70g per week for women.
• Add a criterion to after appendectomy group:Patients who underwent appendectomy in the Department of General Surgery of Zhongshan Hospital Xiamen University within 3 years.

You may not qualify if:

• Those who use antibiotics, antifungal drugs, antiviral drugs, probiotics, prebiotics, synbiotics and drugs that may affect the intestinal microecology within 1 month;
• Those who have acute enteritis or chronic enteritis and other diagnosed chronic bowel diseases in the past 1 month;
• Those who have digestive symptoms such as blood in the stool, constipation, bloating, abdominal pain, diarrhea and so on in the past 1 month
• History of digestive surgery (including gastrointestinal polyp resection, gastrointestinal tumor surgery and diversion surgery, etc.).

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead

Study Sites (1)

Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361001, China

Location

Related Publications (6)

• Wu J, Hu B. The role of carbon dioxide insufflation in colonoscopy: a systematic review and meta-analysis. Endoscopy. 2012 Feb;44(2):128-36. doi: 10.1055/s-0031-1291487. Epub 2012 Jan 23.

  PMID: 22271023 BACKGROUND

• Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005 Jun 10;308(5728):1635-8. doi: 10.1126/science.1110591. Epub 2005 Apr 14.

  PMID: 15831718 BACKGROUND

• Masahata K, Umemoto E, Kayama H, Kotani M, Nakamura S, Kurakawa T, Kikuta J, Gotoh K, Motooka D, Sato S, Higuchi T, Baba Y, Kurosaki T, Kinoshita M, Shimada Y, Kimura T, Okumura R, Takeda A, Tajima M, Yoshie O, Fukuzawa M, Kiyono H, Fagarasan S, Iida T, Ishii M, Takeda K. Generation of colonic IgA-secreting cells in the caecal patch. Nat Commun. 2014 Apr 10;5:3704. doi: 10.1038/ncomms4704.

  PMID: 24718324 BACKGROUND

• Jalanka J, Salonen A, Salojarvi J, Ritari J, Immonen O, Marciani L, Gowland P, Hoad C, Garsed K, Lam C, Palva A, Spiller RC, de Vos WM. Effects of bowel cleansing on the intestinal microbiota. Gut. 2015 Oct;64(10):1562-8. doi: 10.1136/gutjnl-2014-307240. Epub 2014 Dec 19.

  PMID: 25527456 RESULT

• Drago L, Toscano M, De Grandi R, Casini V, Pace F. Persisting changes of intestinal microbiota after bowel lavage and colonoscopy. Eur J Gastroenterol Hepatol. 2016 May;28(5):532-7. doi: 10.1097/MEG.0000000000000581.

  PMID: 27015015 RESULT

• Nagata N, Tohya M, Fukuda S, Suda W, Nishijima S, Takeuchi F, Ohsugi M, Tsujimoto T, Nakamura T, Shimomura A, Yanagisawa N, Hisada Y, Watanabe K, Imbe K, Akiyama J, Mizokami M, Miyoshi-Akiyama T, Uemura N, Hattori M. Effects of bowel preparation on the human gut microbiome and metabolome. Sci Rep. 2019 Mar 11;9(1):4042. doi: 10.1038/s41598-019-40182-9.

  PMID: 30858400 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

feces

Study Officials

• Hongzhi Xu

  Zhongshan Hospital Xiamen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 5, 2022
• Study Start: February 1, 2022
• Primary Completion: July 14, 2022
• Study Completion: December 31, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 6 months after publication.
• Access Criteria: To the public.

Locations

CN (1)