Polyethylene Glycol 3350 for Postoperative Bowel Function

Overseen By Kyrstin Warnimont, Master of Science

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Chicago

Must not be taking: Laxatives, Enemas, Suppositories

Disqualifiers: CKD, IDDM, Cardiac disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if taking the laxative polyethylene glycol 3350 before surgery can improve bowel movements for women after a minimally invasive hysterectomy. Many women experience constipation following this type of surgery, which can be very uncomfortable. The study compares women who take the laxative for 10 days before surgery with those who do not take it. Women scheduled for a minimally invasive hysterectomy who do not regularly use laxatives might be suitable candidates for this trial. As a Phase 4 trial, this research focuses on understanding how this FDA-approved treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you regularly use PEG 3350, laxatives, enemas, or suppositories, you cannot participate in the trial.

What is the safety track record for Polyethylene Glycol 3350?

Research has shown that Polyethylene Glycol 3350 (PEG 3350) is generally safe and easy to tolerate. Studies have found that for constipation, PEG 3350 leads to more frequent bowel movements than a placebo. Specifically, individuals using PEG experienced about 4.2 bowel movements per week, compared to 2.9 with a placebo.

PEG 3350 draws water into the bowel, softening stools and making them easier to pass. Most of this compound exits the body in the stool, contributing to its tolerability.

In terms of safety, PEG 3350 has been tested in individuals with long-term constipation. These studies found it to be safe, with few side effects. Since it is not absorbed into the body, the risk of side effects is reduced. Overall, PEG 3350 is considered a safe and reliable option for treating constipation. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Polyethylene Glycol 3350 (PEG 3350) for improving postoperative bowel function because it offers a gentle but effective way to prepare the bowel before surgery. Unlike traditional bowel prep options, which can be harsh and lead to discomfort, PEG 3350 is known for its mild action, drawing water into the colon without causing significant electrolyte imbalances. This treatment stands out for its ease of use, as patients take it as a simple daily dose leading up to surgery, potentially enhancing recovery by ensuring the bowel is in optimal condition for the procedure.

What evidence suggests that polyethylene glycol 3350 might be an effective treatment for postoperative constipation?

Research shows that polyethylene glycol 3350 (PEG 3350) effectively treats constipation. Studies have found that PEG 3350 increases the number of bowel movements. For instance, participants taking PEG had about 4.2 bowel movements a week, compared to 2.9 with a placebo (a treatment with no active ingredients). The American College of Gastroenterology strongly recommends PEG 3350 for improving bowel movement frequency and ease. In this trial, some participants will receive PEG 3350 as a pre-operative laxative, which might help with constipation after gynecologic surgery. ^{1 4 6 7 8}

Who Is on the Research Team?

Diane Glass, MD, PhD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who are about to have minimally invasive hysterectomy surgery and can understand the consent process. It's not for those who regularly use laxatives, have swallowing difficulties, bowel obstructions, certain medical conditions like chronic kidney disease or insulin-dependent diabetes mellitus, or are having emergency surgery.

Inclusion Criteria

Able to understand the consenting process and willing to participate in study

Exclusion Criteria

I have a colostomy.

You have insulin-dependent diabetes mellitus (IDDM).

I need surgery urgently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants in the intervention arm receive a 10-day preoperative bowel regimen with polyethylene glycol (PEG) daily

10 days

1 visit (in-person) for baseline assessment

Surgery and Immediate Postoperative

Participants undergo minimally invasive hysterectomy and complete a 7-day postoperative diary recording bowel movements and pain levels

7 days

1 visit (in-person) for surgery

Follow-up

Participants complete follow-up questionnaires to assess bowel function and quality of life

1 week

1 visit (virtual or in-person) for follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• Polyethylene Glycol 3350

Trial Overview The study tests if taking a bowel-cleaning agent called Polyethylene Glycol (PEG) 3350 daily for 10 days before surgery improves postoperative bowel function in women undergoing minimally invasive hysterectomy compared to no preoperative regimen.

How Is the Trial Designed?

Group I: Participants receiving pre-operative laxative Experimental Treatment 1 Intervention

Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.

Group II: Participants not receiving pre-operative laxative Active Control 1 Intervention

Participants will not be given any laxatives.

Polyethylene Glycol 3350 is already approved in United States, Canada, European Union for the following indications:

Approved in United States as MiraLAX for:

• Constipation
• Bowel preparation for colonoscopy or surgery

Approved in Canada as Polyethylene Glycol 3350 for:

• Constipation
• Bowel preparation for colonoscopy or surgery

Approved in European Union as Macrogol 3350 for:

• Constipation
• Faecal impaction
• Bowel preparation for colonoscopy or surgery

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

In a study involving 115 patients with chronic constipation, polyethylene glycol (PEG) 3350 was found to be more effective than lactulose, resulting in a higher number of stools and less straining after four weeks.

PEG 3350 was better tolerated than lactulose, with fewer reports of flatus and no serious adverse events, indicating it is a safe option for treating chronic constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Attar, A., Lémann, M., Ferguson, A., et al.[2022]

In a study involving 156 patients with chronic constipation, PEG3350 plus electrolytes (PEG3350 + E) significantly increased the frequency of spontaneous bowel movements compared to placebo, demonstrating its efficacy in resolving constipation.

The long-term use of PEG3350 + E over 52 weeks was well tolerated, with only mild gastrointestinal side effects reported, indicating its safety for chronic use in managing constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene glycol 3350 plus electrolytes for chronic constipation: a 2-week, randomized, double-blind, placebo-controlled study with a 52-week open-label extension. Nakajima, A., Shinbo, K., Oota, A., et al.[2020]

In a study of 304 patients with chronic constipation, PEG 3350 (MiraLAX) was found to be significantly more effective than placebo, with 52% of PEG users achieving treatment success compared to only 11% of those on placebo (P < 0.001).

The study demonstrated that PEG laxative is safe for long-term use, as there were no significant differences in adverse events or laboratory findings compared to placebo, although some gastrointestinal side effects like diarrhea and nausea were reported more frequently with PEG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Dipalma, JA., Cleveland, MV., McGowan, J., et al.[2022]

In a study involving 311 patients, including 117 elderly individuals, polyethylene glycol 3350 (MiraLAX) was found to be safe and effective for treating chronic constipation over a 12-month period, with 80-88% of patients reporting successful treatment outcomes.

The treatment was associated with mild to moderate gastrointestinal side effects, such as diarrhea and nausea, but there were no significant changes in blood chemistry or hematology, indicating a favorable safety profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label study of chronic polyethylene glycol laxative use in chronic constipation. Di Palma, JA., Cleveland, MV., McGowan, J., et al.[2018]

Polyethylene glycol 3350 (MiraLAX) is an effective and safe osmotic laxative for treating chronic constipation in both children and adults, supported by 21 clinical studies involving 1949 patients.

The American College of Gastroenterology has given polyethylene glycol 3350 a grade A recommendation for its ability to improve stool frequency and consistency, indicating strong clinical support for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Over-the-counter laxative polyethylene glycol 3350: an evidence-based appraisal. Zurad, EG., Johanson, JF.[2019]

In a study involving 23 patients with constipation, daily treatment with 17 g of polyethylene glycol (PEG) laxative significantly increased bowel movement frequency to once per day compared to a placebo, which resulted in about one bowel movement every two days.

The PEG treatment not only improved bowel movement frequency but also enhanced patients' subjective symptoms related to constipation, with no significant adverse effects observed in blood chemistry or other health markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. Cleveland, MV., Flavin, DP., Ruben, RA., et al.[2018]

In a study of 150 patients undergoing colonoscopy, the split-dose PEG-AA regimen provided significantly better bowel preparation quality compared to the single-dose PEG-3350 combined with a sports drink and bisacodyl, as measured by the Boston Bowel Preparation Scale.

There was no difference in patient satisfaction or serum electrolyte changes between the two regimens, suggesting that PEG-3350 does not offer any benefits over PEG-AA for bowel preparation and should be reconsidered for this use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol-3350 (Miralax®)+1.9-L sports drink (Gatorade®)+2 tablets of bisacodyl results in inferior bowel preparation for colonoscopy compared with Polyethylene Glycol-Ascorbic Acid (MoviPrep®). Khan, MA., Patel, KB., Nooruddin, M., et al.[2020]

A 7-year-old child developed acute kidney injury and altered mental status after using generic PEG 3350, suggesting possible contamination with ethylene glycol, which can lead to serious health issues.

The child's condition improved after treatment, highlighting the importance of recognizing potential contamination in PEG 3350 products, especially when symptoms like metabolic acidosis and kidney injury occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol 3350 Crystal Nephropathy in Association With Glomerular Mesangial Immunoglobin A Deposition. Aly, R., Acharya, R., Zeng, X., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9481403/

Polyethylene Glycol 3350 in the Treatment of Chronic ... Once-daily polyethylene glycol 3350 demonstrated substantial and sustained efficacy and safety over 24 weeks in patients with chronic idiopathic constipation.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557652/

Polyethylene Glycol - StatPearls - NCBI Bookshelf - NIH PEG resulted in 4.2 bowel movements versus placebo 2.9 bowel movements (P <0.01) at the end of week 1 and 4.5 versus 2.7 bowel movements, respectively (p ...

3. withpower.com withpower.com/trial/phase-4-constipation-7-2019-74cf5

Polyethylene Glycol 3350 for Postoperative Bowel Function The American College of Gastroenterology has given polyethylene glycol 3350 a grade A recommendation for its ability to improve stool frequency and consistency, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02292459

Efficacy and Safety of Polyethylene Glycol 3350 (PEG ... The purpose of this study is to evaluate the complete resolution of constipation in participants taking PEG 3350 compared to those taking PEG 4000, based on ...

5. journals.lww.com journals.lww.com/ajg/fulltext/2020/10001/s0457_six_month_efficacy_of_polyethylene_glycol.458.aspx

S0457 Six-Month Efficacy of Polyethylene Glycol (PEG) ... Once-daily PEG 3350 demonstrated substantial and sustained efficacy in patients with CIC over a period of 6 months.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4956069/

Safety of polyethylene glycol 3350 solution in chronic ... Conclusion. PEG 3350 ASC is safe and well tolerated in patients with functional constipation (NCT01885104). Keywords: polyethylene glycols, drug ...

7. go.drugbank.com go.drugbank.com/drugs/DB09287

Polyethylene glycol: Uses, Interactions, Mechanism of Action Following administration of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, up to 85% to 99% of the compound was excreted in the feces.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2006/022015s000_MedR_Part3.pdf

CLINICAL REVIEW - CPY Document - FDA (Polyethylene glycol (PEG) 3350) is a mixture of non-absorbable, non-metabolized polymers of mean molecular weight 3350 (±10%) that act as pure osmotic agents.