CClinicalTrials.gg
Status unknownNCT05277090Updated Mar 14, 2022

Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection

An Early Phase 1 interventional study of 2L of polyethyleneglycol and inulin in Healthy, sponsored by Yanqing Li. Status unknown. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-14.

Sponsored by Yanqing Li · Early Phase 1, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • Healthy

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03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • patients who agree to participant in the study

Exclusion criteria

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.
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Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    polyethyleneglycol only

    participants take 2L of polyethyleneglycol only

    Drug: 2L of polyethyleneglycol

  • Experimental
    polyethyleneglycol puls Inulin

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

    Drug: 2L of polyethyleneglycol · Dietary Supplement: inulin

  • 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 · Combination Product: probiotic combination product

Interventions

  • Drug2L of polyethyleneglycol

    2L of polyethyleneglycol

  • Dietary supplementinulin

    15g inulin per day

  • Combination productprobiotic 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.

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What researchers measure

Primary outcomes

  1. Polyethyleneglycol could lead to changes in the intestinal flora

    People with polyethyleneglycol administration will lead to a decrease of intestinal flora quantity

    Time frame: one year(from 15/3/2022 to 15/3/2023)

Secondary outcomes

  1. inulin and probiotics could improve the recovery of gut microbiota

    inulin and probiotics will improve the recovery of flora quantity after Polyethyleneglycol administration

    Time frame: one year(from 15/3/2022 to 15/3/2023)

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT05277090
Lead sponsor
Yanqing Li
Responsible party
Yanqing Li (Professor, Shandong University) — Sponsor-investigator
First posted
Mar 14, 2022
Start date
Mar 15, 2022 (estimated)
Primary completion
Mar 15, 2022 (estimated)
Completion
Mar 15, 2022 (estimated)
Last update
Mar 14, 2022

Study contacts

Guanjun Kou
Contact
kouguanjun88@126.com
18560086107
Guanjun Kou
principal investigator · Qilu Hospital of Shandong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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