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

Trial Summary

What is the purpose of this trial?

This study will evaluate changes in the fecal microbiome in constipated pediatric patients before and after antegrade continence enema placement and initiation of antegrade enema flushes. Subjects will have their microbiome sequenced prior to placement by obtaining a fecal sample. Pre-antegrade continence enema placement results will be compared to fecal samples obtained at 0, 4, 8 months after placement of the antegrade continence enema and initiation of miralax or golytely flushes to look for changes in bacterial diversity.

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 evidence supports the effectiveness of the drug for treating constipation?

Research shows that polyethylene glycol 3350 (MiraLAX) is effective for short-term treatment of occasional constipation and has been studied for chronic constipation, demonstrating safety and efficacy over a 6-month period. ^{1 2 3 4 5}

Is the enema flush regimen using polyethylene glycol (PEG) 3350 safe for humans?

Polyethylene glycol 3350 (PEG 3350), used in products like MiraLAX and GoLYTELY, is generally considered safe for short-term use in treating constipation, with common side effects being nausea and abdominal cramps. However, there are rare cases of severe complications, such as electrolyte imbalances, especially if not prepared correctly, as seen in a pediatric case. ^{1 2 3 4 5}

How does the enema flush regimen for constipation differ from other treatments?

The enema flush regimen is unique because it involves directly introducing a liquid into the rectum to relieve constipation, which is different from oral treatments like polyethylene glycol (PEG) 3350 that are taken by mouth. This method can provide more immediate relief compared to oral laxatives that need time to work through the digestive system. ^{1 2 4 6 7}

Research Team

Kate Hawa, DO

Principal Investigator

Riley Hospital for Children

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

An open-label study of chronic polyethylene glycol laxative use in chronic constipation. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Over-the-counter laxative polyethylene glycol 3350: an evidence-based appraisal. [2019]

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

MiraLAX is not as effective as GoLytely in bowel cleansing before screening colonoscopies. [2018]

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

A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. [2022]

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

Lethal Complication From Inappropriately Prepared Polyethylene Glycol (Golytely) in a Pediatric Patient. [2021]

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

A randomized, multicenter comparison of polyethylene glycol laxative and tegaserod in treatment of patients with chronic constipation. [2018]

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

New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. [2018]