Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection

Sponsor

Yanqing Li (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05277090

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: 2L of polyethyleneglycol Dietary Supplement: inulin Combination Product: probiotic combination product	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Mar 15, 2022

Anticipated Study Completion Date :

Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: polyethyleneglycol only participants take 2L of polyethyleneglycol only	Drug: 2L of polyethyleneglycol 2L of polyethyleneglycol
Experimental: polyethyleneglycol puls Inulin participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day.	Drug: 2L of polyethyleneglycol 2L of polyethyleneglycol Dietary Supplement: inulin 15g inulin per day
Experimental: polyethyleneglycol puls 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.	Drug: 2L of polyethyleneglycol 2L of polyethyleneglycol 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.

Arm

Intervention/Treatment

Experimental: polyethyleneglycol only

participants take 2L of polyethyleneglycol only

Drug: 2L of polyethyleneglycol

2L of polyethyleneglycol

Experimental: polyethyleneglycol puls Inulin

participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day.

Drug: 2L of polyethyleneglycol

2L of polyethyleneglycol

Dietary Supplement: inulin

15g inulin per day

Experimental: polyethyleneglycol puls 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.

Drug: 2L of polyethyleneglycol

2L of polyethyleneglycol

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.

Outcome Measures

Primary Outcome Measures

Polyethyleneglycol could lead to changes in the intestinal flora [one year(from 15/3/2022 to 15/3/2023)]
People with polyethyleneglycol administration will lead to a decrease of intestinal flora quantity

Secondary Outcome Measures

inulin and probiotics could improve the recovery of gut microbiota [one year(from 15/3/2022 to 15/3/2023)]
inulin and probiotics will improve the recovery of flora quantity after Polyethyleneglycol administration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Yanqing Li

Investigators

Principal Investigator: Guanjun Kou, Qilu Hospital of Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yanqing Li, Professor, Shandong University

ClinicalTrials.gov Identifier:

NCT05277090

Other Study ID Numbers:

2021-SDU-QILU-088

First Posted:

Mar 14, 2022

Last Update Posted:

Mar 14, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Infections

Study Results

No Results Posted as of Mar 14, 2022