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

Trial Summary

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.

What data supports the effectiveness of the treatment PEGLyte bowel preparation for gut microbiome?

Research shows that polyethylene glycol (PEG), a key component of PEGLyte, is effective for bowel cleansing and is commonly used before procedures like colonoscopy. Studies indicate that while PEG can cause short-term changes in gut bacteria, the microbiome tends to return to its original state shortly after cleansing. ^{1 2 3 4 5}

Is PEGLyte safe for humans?

PEGLyte, which contains polyethylene glycol (PEG), has been used safely for bowel preparation in both children and adults. Studies show it does not cause significant changes in electrolytes or blood gases, and it is well-tolerated. Long-term exposure to PEG in children has not shown any adverse effects, suggesting it is generally safe. ^{6 7 8 9 10}

How is the PEGLyte treatment different from other bowel preparation treatments?

PEGLyte is unique because it uses polyethylene glycol (PEG) for bowel preparation, which is known for being effective and safe, especially in patients with fewer health issues. Unlike some other treatments, it doesn't significantly alter gut bacteria or cause major changes in body electrolytes, making it a safer option for bowel cleansing. ^{2 3 10 11 12}

What is the purpose of this trial?

The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal microbiota.

Research Team

Arielle Elkrief, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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 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 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 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]

References

1. Switzerland 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. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Gut microbiota in children with split-dose bowel preparations revealed by metagenomics. [2023]

3. Germany 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. [2019]

4. Australia pubmed.ncbi.nlm.nih.gov

How to predict adequate bowel preparation before colonoscopy using conventional polyethylene glycol: prospective observational study based on survey. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Urinary excretion of polyethylene glycol 3350 during colonoscopy preparation. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Effectiveness of Sodium Picosulfate/Magnesium Citrate (PICO) for Colonoscopy Preparation. [2022]

8. Switzerland 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. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Safety of a 1-Day Polyethylene Glycol 3350 Bowel Preparation for Colonoscopy in Children. [2018]

10. England pubmed.ncbi.nlm.nih.gov

A physiological appraisal of polyethylene glycol and a balanced electrolyte solution as bowel preparation. [2019]

11. England 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. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Hypokalemia following polyethylene glycol-based bowel preparation for colonoscopy in older hospitalized patients with significant comorbidities. [2022]