PEGLyte for Gut Microbiome

(PEG Trial)

Overseen By Alysé Filin, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Antibiotics

Disqualifiers: Cancer, Cardiac disease, Renal dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how a bowel preparation called PEGLyte affects the gut microbiome, the community of bacteria in the intestines. Researchers seek to understand changes in the variety and types of bacteria, as well as their by-products. Participants will take PEGLyte and provide stool samples before and after its use. This trial suits healthy adults who can safely take the preparation and are willing to provide stool samples. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have recently used antibiotics within the last month, you would not be eligible to participate.

Is there any evidence suggesting that PEGLyte bowel preparation is likely to be safe for humans?

Research has shown that PEGLyte, which contains polyethylene glycol (PEG), is safe for bowel preparation in both children and adults. Studies indicate that it is usually well-tolerated and does not cause major side effects. Although PEGLyte is effective, it can temporarily disrupt the balance of gut bacteria. However, this effect is short-lived, and the gut's bacteria typically return to normal after a while. Many people have safely used this treatment, making it a dependable choice for bowel preparation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

PEGLyte is unique because it offers a new approach to preparing the bowel by influencing the gut microbiome. Unlike standard bowel preparations, which primarily focus on cleansing, PEGLyte is being studied for its potential impact on gut health by collecting and analyzing stool samples before and after use. Researchers are excited about this treatment because it might not only prepare the bowel effectively but also provide insights into how it affects the gut microbiome, which could lead to improved digestive health and new therapeutic strategies.

What evidence suggests that PEGLyte bowel preparation is effective for gut microbiome?

Research has shown that PEGLyte effectively cleans the intestines. In a study with 849 individuals undergoing colonoscopy, this preparation successfully cleansed the intestines. In this trial, healthy volunteers will receive PEGLyte bowel preparation, and stool samples will be collected before and after administration to assess its effects. Studies also indicate that while PEGLyte temporarily reduces the variety of gut bacteria, the gut microbiome typically returns to normal within two weeks. This suggests that PEGLyte works well for its purpose, with manageable short-term effects on gut health. ^{1 2 3 6 7}

Who Is on the Research Team?

Arielle Elkrief, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 who can consent to participate and complete a PEG bowel preparation with stool sample collection. It's not for those with gastrointestinal issues, ileus, heart disease, severe kidney problems, recent cancer treatments within a year, antibiotic use in the last month, or swallowing impairments.

Inclusion Criteria

Healthy volunteer participant cohort:

I am over 18 years old.

I have agreed to follow the study's preparation and stool sample collection procedures.

Exclusion Criteria

I have an inflammatory or infectious condition in my digestive system.

I have a blockage in my intestine.

I have a history of heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PEG bowel preparation and collect stool samples before and after administration

1 week

2 visits (in-person)

Follow-up

Participants are monitored for changes in gut microbiota composition, diversity, and metabolome profile

3 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PEGLyte bowel preparation

Trial Overview The study tests how a bowel cleaning solution called PEGLyte affects the gut microbiome's composition and function. Participants will undergo this preparation to see how it impacts their intestinal bacteria diversity and metabolism.

How Is the Trial Designed?

Group I: Healthy volunteer participant cohort Experimental Treatment 1 Intervention

For healthy volunteer participants, PEG bowel preparation will be administered and participants will collect stool samples before and after PEG at specified timepoints.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

In a study of 96 elderly inpatients who received polyethylene glycol-based bowel preparations (PEGBPs) before colonoscopy, the incidence of hypokalemia increased significantly from 5.5% before treatment to 20.5% after treatment, indicating a potential risk associated with PEGBPs in this population.

The study found that 9.6% of patients experienced significant hypokalemia (serum potassium < or =3.0 mEq/L) after PEGBP administration, suggesting that electrolyte monitoring may be necessary, especially for older patients with existing cardiac or renal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypokalemia following polyethylene glycol-based bowel preparation for colonoscopy in older hospitalized patients with significant comorbidities. Ho, JM., Juurlink, DN., Cavalcanti, RB.[2022]

In a study of 19 pediatric patients undergoing split-dose polyethylene glycol (PEG) bowel preparation for colonoscopy, gut microbiota showed a significant decrease in diversity immediately after the procedure, but most measures returned to pre-preparation levels within two weeks.

Specific bacterial genera, such as Escherichia and Veillonella, increased after colonoscopy, while others like Intertinibacter decreased but recovered by four weeks, indicating that gut microbiota in children is resilient and can stabilize after disturbances from bowel preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gut microbiota in children with split-dose bowel preparations revealed by metagenomics. Zou, Y., Zeng, S., Chen, M., et al.[2023]

In a study of 849 patients undergoing colonoscopy, the 1L PEG NER1006 bowel preparation showed superior overall cleansing success and high-quality cleansing in the right colon compared to the standard 2L PEG with ascorbate, particularly with the evening/morning regimen (N2D).

Both NER1006 regimens (N2D and morning-only N1D) demonstrated comparable safety and tolerability to the standard preparation, making NER1006 an effective low-volume alternative for bowel cleansing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial. Bisschops, R., Manning, J., Clayton, LB., et al.[2019]

A new 2 L bowel preparation solution combining polyethylene glycol (PEG) and ascorbic acid was found to be noninferior in efficacy to the standard 4 L PEG with electrolytes, achieving successful gut cleansing in 88.9% of cases compared to 94.8% for the standard solution.

Patients preferred the 2 L PEG + Asc solution, reporting better acceptability and taste, which suggests that this lower-volume preparation could enhance compliance and effectiveness in routine colonoscopy preparations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy. Ell, C., Fischbach, W., Bronisch, HJ., et al.[2022]

A study estimated PEG exposure in children receiving PEGylated therapies for hemophilia, revealing significant annual exposure levels without any reported adverse effects, suggesting long-term safety.

For a 50 kg child on the highest prophylactic dose of FVIII, PEG exposure ranged from 40 to 21,840 mg/year, yet no adverse event patterns related to PEG were identified, indicating that PEG is likely safe for pediatric use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol Exposure with Antihemophilic Factor (Recombinant), PEGylated (rurioctocog alfa pegol) and Other Therapies Indicated for the Pediatric Population: History and Safety. Stidl, R., Denne, M., Goldstine, J., et al.[2020]

A 1-day bowel preparation using PEG-3350 in pediatric patients for colonoscopy is considered safe, with no clinically significant changes in electrolyte levels or renal function observed in the majority of cases.

However, 24% of patients experienced mild hypokalemia post-prep, and younger children (7 years or younger) showed a higher risk of hypoglycemia, indicating a need for careful monitoring in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of a 1-Day Polyethylene Glycol 3350 Bowel Preparation for Colonoscopy in Children. Sahn, B., Chen-Lim, ML., Ciavardone, D., et al.[2018]

In a study of 65 patients undergoing colonoscopy, the new PEG + ascorbic acid (Asc) solution demonstrated a higher overall quality of bowel cleansing compared to sodium picosulphate + magnesium citrate, particularly in the ascending colon and caecum.

Both treatments had similar safety profiles, with common side effects being headache and gastrointestinal issues, indicating that PEG + Asc is a safe and effective alternative for bowel preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of a new 2 litre polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy. Worthington, J., Thyssen, M., Chapman, G., et al.[2019]

In a study of 77 patients, polyethylene glycol with a balanced electrolyte solution (PEG + E) was found to be a safe and effective bowel preparation method, with over 80% of patients achieving moderate to good results.

PEG + E did not cause significant changes in electrolytes or blood gases, nor did it alter colonic microflora or produce excessive gas, making it a preferable alternative to traditional methods like mannitol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A physiological appraisal of polyethylene glycol and a balanced electrolyte solution as bowel preparation. Ambrose, NS., Johnson, M., Burdon, DW., et al.[2019]

In a study of 892 patients, bowel preparation with three packets of sodium picosulfate/magnesium citrate (Group A) resulted in the highest patient satisfaction (72%) compared to two different regimens that included polyethylene glycol (PEG).

While the regimen with two packets of PICO and 2 L of PEG (Group C) provided better cleansing of the right colon, it was associated with more nausea and bloating, leading to the lowest patient preference (45.9%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Sodium Picosulfate/Magnesium Citrate (PICO) for Colonoscopy Preparation. Song, KH., Suh, WS., Jeong, JS., et al.[2022]

A study involving 12 participants showed that bowel cleansing with polyethylene glycol (PEG) significantly alters the intestinal microbiota, with the most notable changes occurring around 3 days post-cleansing, but the microbiota structure returns to a state similar to pre-cleansing by day 7.

Key bacteria affected by PEG bowel cleansing included Bacteroides, Roseburia, Eubacterium, and Bifidobacterium, and a humanized mouse model demonstrated similar effects, suggesting that the changes in microbiota are a temporary response to the cleansing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Time-Point Fecal Sampling in Human and Mouse Reveals the Formation of New Homeostasis in Gut Microbiota after Bowel Cleansing. Li, M., Qian, W., Yu, L., et al.[2022]

A study involving 465 participants found that bowel preparation for colonoscopy using 4-L polyethylene glycol (PEG) was most effective when using a split method for morning procedures, resulting in the highest preparation scores.

Key factors for adequate bowel preparation included consuming PEG less than 5 hours before the procedure, having more than 5 defecations, and achieving liquid stool without solid material immediately before colonoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to predict adequate bowel preparation before colonoscopy using conventional polyethylene glycol: prospective observational study based on survey. Kim, HG., Jeon, SR., Kim, MY., et al.[2018]

In a study of 24 patients undergoing bowel cleansing with PEG 3350 for colonoscopy, the absorption of PEG was found to be higher than previously thought, with urinary excretion ranging from 0.01% to 0.51% of the ingested amount.

Patients with inflammatory bowel disease did not show significantly higher PEG absorption compared to those with normal intestinal mucosa, suggesting that intestinal inflammation does not necessarily increase PEG permeability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary excretion of polyethylene glycol 3350 during colonoscopy preparation. Rothfuss, KS., Bode, JC., Stange, EF., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-11-2024-0da5e

PEGLyte for Gut Microbiome (PEG Trial) In a study of 849 patients undergoing colonoscopy, the 1L PEG NER1006 bowel preparation showed superior overall cleansing success and high-quality cleansing in ...

2. trial.medpath.com trial.medpath.com/clinical-trial/5232eeef2e7d8256/nct06831539-peg-bowel-prep-gut-microbiome

Impact of PEG Bowel Preparation on Gut Microbiome ... The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6411954/

Effects of bowel preparation on the human gut microbiome ... We confirmed previous results showing that the gut microbiome is affected transiently by bowel prep but recovers quickly within 14 days. For the ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06831539/impact-of-peg-bowel-preparation-on-gut-microbiome-composition-recovery

Impact of PEG Bowel Preparation on Gut Microbiome ... The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal ...

5. mdpi.com mdpi.com/2072-6643/15/5/1141

Benefits of Probiotic Pretreatment on the Gut Microbiota ... The results of the present study showed that the gut microbial diversity decreased after bowel preparation and similar microbiota reduction was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6020982/

protocol for a systematic review and network meta-analysis The objective is to assess the comparative safety of various bowel cleansers with or without bisacodyl, with a primary interest inpolyethylene glycol (PEG)- ...

7. e-ce.org e-ce.org/journal/view.php?number=7938

Alteration in gut microbiota after colonoscopy Split-dose bowel preparation and CO2 insufflation during the procedure result in fewer alterations in the gut microbiota. Probiotic ...