Enema Flush Regimen for Constipation

Recruiting at 1 trial location

Overseen By Ann Klipsch, RN

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Indiana University

Must not be taking: Probiotics, Prebiotics, Antibiotics

Disqualifiers: GI surgery, Severe GI 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

Compensation: Varies

Number of Visits: 2

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores changes in the gut bacteria of children with chronic constipation before and after using a special enema treatment. Participants will receive either PEG 3350 (a laxative) or PEG 3350 with electrolytes for their flushes. Researchers will compare gut bacteria from samples taken before and several months after starting the treatment. Children with long-term constipation who require a procedure called MACE to aid bowel movements might be suitable for this trial. As a Phase 4 trial, this study involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have used probiotic supplements, prebiotic supplements, or antibiotics in the month before joining.

What is the safety track record for these treatments?

Research shows that PEG 3350, commonly known as Miralax, is generally safe for treating constipation. It draws water into the intestines, softening stools and making them easier to pass. Studies have found that it is well-tolerated and causes few side effects, even with long-term use, making it a preferred choice for chronic constipation.

PEG 3350 with electrolytes, such as GoLYTELY, is also used to clean out the colon, often before medical tests. However, its safety and effectiveness in children remain uncertain. Some risks include dehydration, heart rhythm problems, and kidney issues. While these effects can occur, they are uncommon.

Both treatments aid bowel function, but the version with electrolytes carries more potential risks. Always consult a healthcare provider to determine the best option. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for constipation because they offer new ways to manage the condition using MACE flushes. PEG 3350 and PEG 3350 with electrolytes are both experimental treatments that differ from standard stool softeners and laxatives by specifically targeting the bowel with a flush technique. The addition of electrolytes in one arm of the study might enhance the body's ability to absorb and process the solution, potentially making it more effective and comfortable for patients. These treatments could provide faster relief compared to traditional oral medications, which is a promising development for those struggling with chronic constipation.

What evidence suggests that this trial's treatments could be effective for constipation?

In this trial, participants will receive either PEG 3350 (known as Miralax or its generic version) or PEG 3350 with electrolytes (such as Go-Lytely) for their MACE flushes. Research has shown that PEG 3350 effectively treats constipation. One study found that people using PEG 3350 had more frequent bowel movements, averaging 4.5 times a week, compared to 2.7 times for those not using it. This indicates that PEG 3350 can significantly increase bowel movement frequency.

PEG 3350 with electrolytes serves similar purposes and is often used to clean out the colon, aiding in constipation relief. Both treatments are generally safe and well-tolerated, making them good options for managing constipation. ^{3 5 6 7 8}

Who Is on the Research Team?

Kate Hawa, DO

Principal Investigator

Riley Hospital for Children

Are You a Good Fit for This Trial?

This trial is for pediatric patients with severe, treatment-resistant constipation who will undergo a procedure called antegrade continence enema at Riley Hospital for Children. They should have normal colonic movement and not have had any GI surgery or used probiotics, prebiotics, or antibiotics in the last month.

Inclusion Criteria

I need a special procedure for my severe constipation not responding to other treatments.

My bowel movements are normal according to tests.

Exclusion Criteria

I have a severe stomach or intestine disease not caused by my chronic constipation.

I have used probiotics, prebiotics, or antibiotics in the last month.

I have a physical reason for my constipation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-MACE Placement

Participants provide a stool sample before MACE placement while abstaining from osmotic laxative therapy for one week

1 week

1 visit (in-person)

Post-MACE Treatment

Participants undergo MACE placement and initiate daily antegrade enema flushes with PEG 3350 or PEG 3350 with electrolytes

8 months

Standard follow-up appointments at 1, 4, and 8 months

Follow-up

Participants are monitored for changes in fecal microbiome diversity after treatment

8 months

What Are the Treatments Tested in This Trial?

Interventions

• Glycerin
• PEG 3350
• PEG-3350 with electrolytes

Trial Overview The study looks at how the fecal microbiome (the community of bacteria in poop) changes after kids start using bowel flushes with PEG 3350 or Golytely following an antegrade continence enema placement. Their poop is tested before and then several times up to 8 months after starting treatment.

How Is the Trial Designed?

Group I: PEG 3350 with electrolytes Experimental Treatment 2 Interventions

Patients will receive PEG 3350 with electrolytes (Go-Lytely or generic equivalent) for their MACE flushes.

Group II: PEG 3350 Experimental Treatment 2 Interventions

Patients will receive PEG 3350 (miralax or generic equivalent) for their MACE flushes.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

In a study involving 403 patients, the standard bowel preparation regimen GoLytely was found to be significantly more effective for bowel cleansing compared to MiraLAX alone or when combined with bisacodyl or lubiprostone, as measured by the Ottawa bowel preparation scale.

Despite being less effective, patients who used MiraLAX reported higher satisfaction with their preparation experience compared to those who used GoLytely, indicating a trade-off between efficacy and patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MiraLAX is not as effective as GoLytely in bowel cleansing before screening colonoscopies. Hjelkrem, M., Stengel, J., Liu, M., et al.[2018]

Polyethylene glycol with electrolytes (PEG-ELS, Golytely) is generally safe for use in both adults and children for colonic preparation and treatment of severe chronic constipation, with minimal side effects like nausea and abdominal cramps.

However, a case report highlights a serious risk when Golytely is improperly prepared for pediatric patients, leading to severe electrolyte disturbances and a tragic outcome, emphasizing the importance of correct preparation and administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lethal Complication From Inappropriately Prepared Polyethylene Glycol (Golytely) in a Pediatric Patient. Skaff, C., Alayed, T.[2021]

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 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]

In a study of 237 patients with chronic constipation, polyethylene glycol (PEG) 3350 (MiraLax) was found to be significantly more effective than tegaserod (Zelnorm), with 50% of PEG patients achieving treatment success compared to 30.8% of tegaserod patients.

PEG not only resulted in more bowel movements and greater symptom improvement but also had a lower incidence of headaches compared to tegaserod, indicating it may be the preferred treatment option for chronic constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, multicenter comparison of polyethylene glycol laxative and tegaserod in treatment of patients with chronic constipation. Di Palma, JA., Cleveland, MV., McGowan, J., et al.[2018]

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]

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]

Citations

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

Polyethylene Glycol - StatPearls - NCBI Bookshelf - NIH PEG is preferred over other agents for chronic constipation and disimpaction as it was associated with limited adverse effects and a better-tasting profile. PEG ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4848251/

Polyethylene glycol 3350 in occasional constipation CONCLUSION: Oral administration of 17 g PEG 3350 once daily for a week is effective, safe, and well tolerated in subjects with occasional constipation. Keywords ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01170754

Miralax (PEG 3350) vs. Golytely as Bowel Preparation for ... The study is a non-inferiority study: The objective is to conclude that the prep quality scores of those receiving Miralax is at most 10% less than for Golytely ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002927099008242

A randomized, placebo-controlled, multicenter study of the ... By wk 2 of treatment, on average, placebo subjects had 2.7 bowel movements/wk and PEG-treated study subjects had 4.5 movements/wk (p < 0.01), or more than one ...

5. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/481370

Safety of Polyethylene Glycol 3350 for the Treatment ... In one study, milk of magnesia was as effective as PEG (67% vs 61%) in children with constipation and encopresis who received these therapies for 12 months.

6. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9PERR_POLYETHYLENE_GLYCOL_PDR_17GM_17_9OZ.pdf

MATERIAL SAFETY DATA SHEET This product's dust or powder may cause eye and respiratory tract irritation. Adverse effects are rare for short-term usage.

7. webmd.com webmd.com/drugs/2/drug-17116/miralax-oral/details

Polyethylene Glycol 3350 (Miralax) - Uses, Side Effects ... Polyethylene glycol 3350 is used for occasional constipation. It works by pulling water into your intestines and making your poop softer and easier to pass.

8. mayoclinic.org mayoclinic.org/drugs-supplements/polyethylene-glycol-3350-and-electrolytes-oral-route/description/drg-20062627

Polyethylene glycol 3350 and electrolytes (oral route) Polyethylene glycol (PEG) and electrolytes combination solution is used to cleanse the colon (bowel) before certain medical tests.