HealthyEarly Phase 1NCT05277090
Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection
A Early Phase 1 study testing 2L of polyethyleneglycol, inulin and probiotic combination product in people with Healthy, run by Yanqing Li.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 2L of polyethyleneglycol, inulin and probiotic combination product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2022to 15 Mar 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who agree to participant in the study
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bowel Preparation for Colonoscopy May Lead to a Higher Feasibility of Intestinal Infection: a Clinical and Basic Research
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.
- Conditions
- Healthy
- Being tested
- 2L of polyethyleneglycol, inulin, probiotic combination product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2L of polyethyleneglycolDrug
2L of polyethyleneglycol
inulinDietary supplement
15g inulin per day
probiotic combination productCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| polyethyleneglycol only | Experimental | participants take 2L of polyethyleneglycol only Receives: Drug: 2L of polyethyleneglycol |
| polyethyleneglycol puls Inulin | Experimental | participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day. Receives: Drug: 2L of polyethyleneglycol; Dietary Supplement: inulin |
| polyethyleneglycol puls probiotic combination product | Experimental | 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. Receives: Drug: 2L of polyethyleneglycol; Combination Product: probiotic combination product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyethyleneglycol could lead to changes in the intestinal flora
People with polyethyleneglycol administration will lead to a decrease of intestinal flora quantity
Measured: 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
Measured: one year(from 15/3/2022 to 15/3/2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start15 Mar 2022 (estimated)
- Primary completion15 Mar 2022 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqing Li, Shandong University
- Investigators
- Guanjun Kou, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277090
- Sponsor's protocol ID
- 2021-SDU-QILU-088
- Status last verified
- Mar 2022
- First submitted
- 19 Oct 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Preparation for Colonoscopy May Lead to a Higher Feasibility of Intestinal Infection: a Clinical and Basic Research
- ClinicalTrials.gov ID
- NCT05277090
- Acronym / sponsor ID
- 2021-SDU-QILU-088
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yanqing LiUniversity, hospital or other
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| polyethyleneglycol only | Experimental | Drug: 2L of polyethyleneglycolparticipants take 2L of polyethyleneglycol only |
| polyethyleneglycol puls Inulin | Experimental | Drug: 2L of polyethyleneglycol, Dietary Supplement: inulinparticipants take 2L of polyethyleneglycol, subsequently take 15g inulin per day. |
| polyethyleneglycol puls probiotic combination product | Experimental | Drug: 2L of polyethyleneglycol, Combination Product: probiotic combination productParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who agree to participant in the study
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2L of polyethyleneglycol2L of polyethyleneglycol | Drug | polyethyleneglycol only, polyethyleneglycol puls Inulin, polyethyleneglycol puls probiotic combination product |
| inulin15g inulin per day | Dietary supplement | polyethyleneglycol puls Inulin |
| probiotic combination productparticipants 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. | Combination product | polyethyleneglycol puls probiotic combination product |
Primary outcome
Polyethyleneglycol could lead to changes in the intestinal flora
Time frame: one year(from 15/3/2022 to 15/3/2023)
People with polyethyleneglycol administration will lead to a decrease of intestinal flora quantity
1 secondary outcome
inulin and probiotics could improve the recovery of gut microbiota
Time frame: one year(from 15/3/2022 to 15/3/2023)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guanjun Kou principal investigator
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 2L of polyethyleneglycol, inulin and probiotic combination product in people with Healthy, run by Yanqing Li.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guanjun Kou (18560086107, kouguanjun88@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyethyleneglycol could lead to changes in the intestinal flora (time frame: one year(from 15/3/2022 to 15/3/2023)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.