Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection

Healthy Clinical Trial

Official title:

Bowel Preparation for Colonoscopy May Lead to a Higher Feasibility of Intestinal Infection: a Clinical and Basic Research

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05277090
• Other study ID #: 2021-SDU-QILU-088
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: March 15, 2022
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2022
• Source: Shandong University
• Contact: Guanjun Kou
• Phone: 18560086107
• Email: kouguanjun88[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An adequate bowel preparation is essential for a high quality of colonscopy. Nowdays, polyethyleneglyco is considered the most safe drug for bowel preparation, and is widely used around the world. However, previous study illustrated that bowel preparation by polyethyleneglyco could lead to qualitative changes in the intestinal microbiota both in mice and human. This study is aimed to investigate wether the changes in the intestinal microbiota could lead to a higher rate of intestinal infection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients who agree to participant in the study

Exclusion Criteria:

• patients who couldn't stand polyethyleneglycol or inulin patients couldn't provide Informed consent patients who are suffering from sever heart disease, pulmonary disease or renal dysfunction.

Related Conditions & MeSH terms

• Healthy
• Infections

Intervention

Drug:
• 2L of polyethyleneglycol
2L of polyethyleneglycol

Dietary Supplement:
• inulin
15g inulin per day

Combination Product:
• probiotic combination product
participants take 2L of polyethyleneglycol, subsequently take 15g probiotics combination product (including Bifidobacterium lactis, Lactobacillus plantarum, inlulin, Vitamin C) per day. The probiotic combination product, named "Mei Ri Yi Jun" was produced by Wedge Pharmaceuticals.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yanqing Li

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polyethyleneglycol could lead to changes in the intestinal flora	People with polyethyleneglycol administration will lead to a decrease of intestinal flora quantity	one year(from 15/3/2022 to 15/3/2023)
Secondary	inulin and probiotics could improve the recovery of gut microbiota	inulin and probiotics will improve the recovery of flora quantity after Polyethyleneglycol administration	one year(from 15/3/2022 to 15/3/2023)