Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection

NCT ID: NCT05277090

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2022-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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polyethyleneglycol only

participants take 2L of polyethyleneglycol only

Group Type EXPERIMENTAL

2L of polyethyleneglycol

Intervention Type DRUG

2L of polyethyleneglycol

polyethyleneglycol puls Inulin

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

Group Type EXPERIMENTAL

2L of polyethyleneglycol

Intervention Type DRUG

2L of polyethyleneglycol

inulin

Intervention Type DIETARY_SUPPLEMENT

15g inulin per day

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.

Group Type EXPERIMENTAL

2L of polyethyleneglycol

Intervention Type DRUG

2L of polyethyleneglycol

probiotic combination product

Intervention Type 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.

Interventions

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2L of polyethyleneglycol

2L of polyethyleneglycol

Intervention Type DRUG

inulin

15g inulin per day

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yanqing Li

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Guanjun Kou

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Central Contacts

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Guanjun Kou

Role: CONTACT

18560086107

Other Identifiers

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2021-SDU-QILU-088

Identifier Type: -

Identifier Source: org_study_id

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