Colon PolypPhase 4NCT06339697

Short-term Effects of Bowel Preparation on Gut Microbiome in Patients Undergoing Endoscopic Colon Polypectomy

A Phase 4 study testing different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate) in people with Colon Polyp and Cathartic Colon, run by Zhang Yanli at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the role of different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate) on the composition, evolution and recovery of the gut microbiome of patients with colonic polyps undergoing bowel preparation. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Colon Polyp, Cathartic Colon
What is being tested?: different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 194 participants
Where: 1 siteChina
Study dates: 1 Dec 2022to 30 Jun 2023
Phase: Phase 4
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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All colon polyps diagnosed by electronic colonoscopy
Age above 18 years old
Patients sign an informed consent form, agree to cooperate with the study of this project, and collect fecal specimens on time to receive follow-up visits

Who cannot join

Patients who received antibiotics, PPIs 2 weeks before the study
Patients who consumed probiotics or herbs 2 weeks prior to the study
Had a colonoscopy or used diarrhea-inducing drugs or gastrointestinal stimulants 1 week prior to the study
Gastrointestinal surgery and gastrointestinal endoscopic procedures in the 1 month prior to the study
Bacterial or parasitic intestinal infections in the 1 month prior to the study
Patients on long-term low-calorie diets, vegan diets, gluten-free diets and other "special" diets

Show all 12Show fewer

Pregnant/nursing patients
Patients with a history of hypersensitivity to relevant medications
Patients with contraindications to sodium picosulfate: renal insufficiency, renal transplant recipients, congestive heart failure, symptomatic ischemic heart disease within the last 6 months, cirrhosis of the liver, patients on hemodialysis or peritoneal dialysis, patients taking certain medications - renin-angiotensin blockers, diuretics, non-steroidal anti-inflammatory drugs (NSAIDs), and patients taking medications known to trigger the syndrome of inappropriate secretion of antidiuretic hormone. patients taking medications known to induce the syndrome of inappropriate antidiuretic hormone secretion (tricyclic antidepressants, selective 5-hydroxytryptamine reuptake inhibitors, multiple antipsychotics, and carbamazepine)
Patients with contraindications to colonoscopy, such as severe hypertension, anemia, coronary artery disease, cardiopulmonary insufficiency, etc.
Patients with contraindications to drug-induced diarrhea, such as intestinal obstruction, electrolyte disorders, or severe renal insufficiency.
Any other reason the investigator considers inappropriate for enrollment

Trial locations and contacts

1 site in 1 country.

China1 site

China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Read the detailed description

Good and adequate bowel preparation is essential for colonoscopy, especially in patients requiring endoscopic treatment, and the role of bowel purgatives and their safety for patients has been extensively studied. There are several laxatives available in clinical practice, the most widely used being electrolyte-supplemented polyethylene glycol (PEG) solutions, and other types of laxatives such as compound sodium picosulfate (SP) have been developed subsequently.

When a large amount of laxative passes through the intestine, many microorganisms are removed from the intestine. Thus leading to significant changes in the composition of the intestinal microbiota during intestinal cleansing. There is no consensus on how gut cleansing affects the gut microbiome.

There are no studies exploring whether there are differences in the effects of different types of laxatives on the human gut microbiome. In this study, focusing on patients diagnosed with colon polyps, the investigators explored the effects on the composition, evolution, recovery and functional pathways of the patients' gut microbiome after the use of different types of laxatives and endoscopic treatment.

Conditions: Colon Polyp, Cathartic Colon
Being tested: different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate)
Keywords: bowel preparation, gut microbiome, Cathartics
Medical subject headings: Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate)Drug
Bowel preparation with different types of laxatives (compounded polyethylene glycol electrolytes and compounded sodium picosulfate)

Study groups in NCT06339697
Study group	Role	What they receive
compounded polyethylene glycol electrolyte dispersions	Active comparator	For patients undergoing colonoscopic polypectomy in the morning, 2-3 L should be taken the night before and 1-2 L the morning of the procedure, and for patients undergoing colonoscopy in the afternoon, divided doses should be taken on the same day. Receives: Drug: different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate)
compounded sodium pico-sulfate	Active comparator	Oral sodium picolinate/magnesium citrate (PicolaxÒ), 2 sachets, each sachet contains 0.01 g of sodium picolinate, 3.5 g of magnesium oxide, 12.0 g of citric acid, each sachet should be dissolved in 150 ml of water, sachet 1 should be taken at 7:00 p.m.-9:00 p.m. on the first day of the operation, and cite 1,500-2,000 ml of clarified fluids after the dose and before going to bed, sachet 2 should be taken 4-6 hours prior to colonoscopy, and 750 ml of clarified fluids should be taken orally before the colonoscopy. The second bag should be taken 4-6 hours before the colonoscopy and 750 ml of clarified liquid should be taken orally before the colonoscopy. Receives: Drug: different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate)

What is being measured

The primary outcome is the main question the study is designed to answer.

gut microbiome-taxonomy
16s sequencing results of feces. Based on the abundance information (absolute and relative) from ZOTU and its taxonomic annotations, the total number of sequences at each taxonomic level (Kingdom, Phylum, Class, Order, Family, Genus) for each sample and its proportion of the total number of sequences were summarized.
Measured: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
gut microbiome-heatmap
Based on the species annotations and abundance information of all samples at the genus level, the genera of concern (30 genera with high default abundance rankings) and their abundance information in each sample are selected to draw heat maps. At the same time, and clustering at both the level of taxonomic information and differences between samples, one can look for patterns of aggregation of species or samples.
Measured: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
gut microbiome-Alpha Diversity
Includes both the diversity of species in the sample (Richness) and the overall evenness of the distribution of how many species make up the sample (Evenness). Indices such as Richness, Chao1, Shannon, Simpson, Dominance and Equitability are commonly used to assess the species diversity of a sample.
Measured: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
gut microbiome-Beta Diversity
Beta Diversity is a comparison of microbial community composition between samples. Bray Curtis, Weighted UniFrac and Unweighted UniFrac distances were calculated based on the ZOTUs abundance information of the samples to assess the differences in microbial community composition between samples. Based on the above distance matrix, it was analyzed by multivariate statistical methods such as Principal Component Analysis, Principal Co-ordinates AnalysisUnweighted Pair-group Method with Arithmetic Means to further from the results to explore the differences in microbial community structure in each sample and the differences in the contribution of different classifications to the samples.
Measured: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
gut microbiome-Functional predictions
In the 16S analysis, a preliminary functional spectrum prediction analysis was performed. The constructed ZOTU sequences were aligned with bacterial 16S sequence databases of known function (e.g., KEGG 16S Sequence Database, Silva SSU Database,) to obtain information on bacterial abundance in environmental samples. This abundance information is mapped directly or indirectly to the annotated microbial genomes of the KEGG databases, combined with the number of 16S rRNA genes and the abundance information of the functional genes (characterized using the KEGG Ortholog, KO), to obtain functional data on (some of the) known bacteria contained in the samples, as well as their abundance information.
Measured: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation

Secondary outcomes (10)

Age
Age (how old)
Measured: Before bowel preparation
Gender
Male or female
Measured: Before bowel preparation
Height
How many centimeters?
Measured: Before bowel preparation
Weight
How many kilograms?
Measured: Before bowel preparation
BMI
kg/cm2
Measured: Before bowel preparation
Whether the enrollee is a smoker
Defined as current regular cigarette smoking
Measured: Before bowel preparation
Whether the enrollee is a drinker
Defined as drinking of alcohol at least three times per week
Measured: Before bowel preparation
Evaluation of the effectiveness of intestinal cleansing Evaluation of the effectiveness of intestinal cleansing
A Boston Rating Scale was used, with cleanliness on a 4-point scale (0-3) and a total score (0-9).
Measured: Within 24 hours after bowel preparation
Gastrointestinal Symptom Score
The Gastrointestinal Symptom Rating Scale (GSRS) consists of 15 questions covering 5 aspects of gastrointestinal symptoms: abdominal pain (including abdominal pain, nausea and vomiting), reflux, diarrhea (including diarrhea, loose stools, incontinence of stool, and urgency to defecate), dyspepsia (including ringing in the abdomen, abdominal distention, belching, and increased exhaustion of gas), constipation (including constipation, hard stools, and incomplete evacuation of bowel movements), with 4 answers per question. Each question provided 4 answers, and each symptom was scored from mild to severe, with scores ranging from 0 to 3. Finally, each item was summed up to give a total score, with higher scores suggesting that the patient's gastrointestinal symptoms were more severe. All the scales were filled out independently within 10-15 minutes by a uniformly trained physician who instructed the patients to review their symptoms within 1 month.
Measured: Within 2 weeks after bowel preparation
adverse event
Any discomfort complained of by the patient
Measured: Within 2 weeks after bowel preparation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202230 Jun 2023

First posted1 Apr 2024
Study start1 Dec 2022
Primary completion30 Jun 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colon PolypStudies 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: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 194 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06339697
Sponsor's protocol ID: 2022-KY-233
Status last verified: Mar 2024
First submitted: 28 Feb 2024
Last updated: 1 Apr 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colon Polyp trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short-term Effects of Bowel Preparation on Gut Microbiome in Patients Undergoing Endoscopic Colon Polypectomy
ClinicalTrials.gov ID: NCT06339697
Acronym / sponsor ID: 2022-KY-233
Conditions: Colon Polyp, Cathartic Colon
Keywords: bowel preparation, gut microbiome, Cathartics
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 194 participants (actual)
Lead sponsor: Zhang YanliUniversity, hospital or other
Study start: 1 Dec 2022 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 1 Apr 2024 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
compounded polyethylene glycol electrolyte dispersions	Active comparator	Drug: different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate)For patients undergoing colonoscopic polypectomy in the morning, 2-3 L should be taken the night before and 1-2 L the morning of the procedure, and for patients undergoing colonoscopy in the afternoon, divided doses should be taken on the same day.
compounded sodium pico-sulfate	Active comparator	Drug: different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate)Oral sodium picolinate/magnesium citrate (PicolaxÒ), 2 sachets, each sachet contains 0.01 g of sodium picolinate, 3.5 g of magnesium oxide, 12.0 g of citric acid, each sachet should be dissolved in 150 ml of water, sachet 1 should be taken at 7:00 p.m.-9:00 p.m. on the first day of the operation, and cite 1,500-2,000 ml of clarified fluids after the dose and before going to bed, sachet 2 should be taken 4-6 hours prior to colonoscopy, and 750 ml of clarified fluids should be taken orally before the colonoscopy. The second bag should be taken 4-6 hours before the colonoscopy and 750 ml of clarified liquid should be taken orally before the colonoscopy.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

All colon polyps diagnosed by electronic colonoscopy
Age above 18 years old
Patients sign an informed consent form, agree to cooperate with the study of this project, and collect fecal specimens on time to receive follow-up visits

Key exclusion criteria (12 listed)

Patients who received antibiotics, PPIs 2 weeks before the study
Patients who consumed probiotics or herbs 2 weeks prior to the study
Had a colonoscopy or used diarrhea-inducing drugs or gastrointestinal stimulants 1 week prior to the study
Gastrointestinal surgery and gastrointestinal endoscopic procedures in the 1 month prior to the study
Bacterial or parasitic intestinal infections in the 1 month prior to the study

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
different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate)Bowel preparation with different types of laxatives (compounded polyethylene glycol electrolytes and compounded sodium picosulfate)	Drug	compounded polyethylene glycol electrolyte dispersions, compounded sodium pico-sulfate

Primary outcome

gut microbiome-taxonomy
Time frame: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
16s sequencing results of feces. Based on the abundance information (absolute and relative) from ZOTU and its taxonomic annotations, the total number of sequences at each taxonomic level (Kingdom, Phylum, Class, Order, Family, Genus) for each sample and its proportion of the total number of sequences were summarized.
gut microbiome-heatmap
Time frame: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
Based on the species annotations and abundance information of all samples at the genus level, the genera of concern (30 genera with high default abundance rankings) and their abundance information in each sample are selected to draw heat maps. At the same time, and clustering at both the level of taxonomic information and differences between samples, one can look for patterns of aggregation of species or samples.
gut microbiome-Alpha Diversity
Time frame: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
Includes both the diversity of species in the sample (Richness) and the overall evenness of the distribution of how many species make up the sample (Evenness). Indices such as Richness, Chao1, Shannon, Simpson, Dominance and Equitability are commonly used to assess the species diversity of a sample.
gut microbiome-Beta Diversity
Time frame: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
Beta Diversity is a comparison of microbial community composition between samples. Bray Curtis, Weighted UniFrac and Unweighted UniFrac distances were calculated based on the ZOTUs abundance information of the samples to assess the differences in microbial community composition between samples. Based on the above distance matrix, it was analyzed by multivariate statistical methods such as Principal Component Analysis, Principal Co-ordinates AnalysisUnweighted Pair-group Method with Arithmetic Means to further from the results to explore the differences in microbial community structure in each sample and the differences in the contribution of different classifications to the samples.
gut microbiome-Functional predictions
Time frame: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
In the 16S analysis, a preliminary functional spectrum prediction analysis was performed. The constructed ZOTU sequences were aligned with bacterial 16S sequence databases of known function (e.g., KEGG 16S Sequence Database, Silva SSU Database,) to obtain information on bacterial abundance in environmental samples. This abundance information is mapped directly or indirectly to the annotated microbial genomes of the KEGG databases, combined with the number of 16S rRNA genes and the abundance information of the functional genes (characterized using the KEGG Ortholog, KO), to obtain functional data on (some of the) known bacteria contained in the samples, as well as their abundance information.

10 secondary outcomes

Age
Time frame: Before bowel preparation
Gender
Time frame: Before bowel preparation
Height
Time frame: Before bowel preparation
Weight
Time frame: Before bowel preparation
BMI
Time frame: Before bowel preparation
Whether the enrollee is a smoker
Time frame: Before bowel preparation
Whether the enrollee is a drinker
Time frame: Before bowel preparation
Evaluation of the effectiveness of intestinal cleansing Evaluation of the effectiveness of intestinal cleansing
Time frame: Within 24 hours after bowel preparation
Gastrointestinal Symptom Score
Time frame: Within 2 weeks after bowel preparation
adverse event
Time frame: Within 2 weeks after bowel preparation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
Individual participant dataSharing planned: No

Related trials for Colon Polyp

Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 12 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: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

gut microbiome-taxonomy (time frame: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06339697.

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 1 Apr 2024.