Bowel Preparation with CLENPIQ vs. MIRALAX for Colon Cleansing

(PICCOLO Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Ferring Pharmaceuticals

Must not be taking: Lithium, Laxatives, Antidiarrheals, others

Disqualifiers: Liver disease, Cardiovascular, Renal, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial focuses on bowel preparation for children who need a colonoscopy. The preparation involves taking a solution or medication that cleans out their intestines by causing frequent bathroom trips.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before the procedure: lithium (48 hours prior), laxatives (24 hours prior), drugs causing constipation (48 hours prior), antidiarrheal drugs (72 hours prior), and oral iron preparations (1 week prior).

What data supports the effectiveness of the drug CLENPIQ compared to MIRALAX for colon cleansing?

Research suggests that MiraLAX, when used with Gatorade, is gaining acceptance for bowel cleansing, but it may not be as effective as other preparations like GoLytely or MoviPrep. This implies that while MiraLAX is popular for its tolerability, its effectiveness might be less than some other options. ^{1 2 3 4 5}

Is the bowel preparation with CLENPIQ and MIRALAX safe for humans?

Studies have shown that both CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) and MIRALAX (polyethylene glycol 3350) are generally safe for use in humans for bowel preparation, although there may be concerns about fluid and electrolyte balance with CLENPIQ. ^{1 5 6 7 8}

How does the bowel preparation with CLENPIQ differ from other colon cleansing treatments?

CLENPIQ is a ready-to-drink, low-volume bowel preparation solution that combines sodium picosulfate, magnesium oxide, and citric acid, making it more convenient and potentially easier to tolerate compared to traditional high-volume preparations like MIRALAX, which requires mixing with a large volume of liquid. ^{9 10 11 12 13}

Research Team

Global Clinical Compliance

Principal Investigator

Ferring Pharmaceuticals

Eligibility Criteria

This trial is for boys and girls aged 2 to <9 years, weighing at least 10 kg, who are scheduled for a colonoscopy and have regular bowel movements. They must not have certain gastrointestinal disorders or electrolyte imbalances, nor should they be on medications that affect bowel movements or have had recent surgeries affecting the gut.

Inclusion Criteria

I have had 3 or more bowel movements per week for the last month.

I am between 2 and 8 years old and scheduled for a colonoscopy.

I weigh at least 22 pounds.

Exclusion Criteria

I have had significant stomach pain recently.

I have severe IBD symptoms right now.

I have a history of serious stomach or intestine problems.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Treatment

Participants receive bowel preparation with either MIRALAX or CLENPIQ prior to colonoscopy

1 day

1 visit (in-person) for colonoscopy

Follow-up

Participants are monitored for safety and effectiveness after colonoscopy

4 weeks

Treatment Details

Interventions

• CLENPIQ (Laxative)
• MIRALAX (Laxative)

Trial Overview The study is testing CLENPIQ versus MIRALAX as methods to clean out the bowels before a child undergoes a colonoscopy. The goal is to determine which one works better in preparing children's colons for clear viewing during the procedure.

Participant Groups

Group I: Participants aged 4 to <9 years: CLENPIQ Experimental Treatment 1 Intervention

CLENPIQ administered using "split-dose" method and consists of two separate doses: the first dose (1 bottle \[approximately 160 mL\]) one day before colonoscopy between 5:00 PM and 9:00 PM, and the second dose (½ bottle \[approximately 80 mL\]) the next day, at least 5 hours prior but no more than 9 hours prior to the colonoscopy. Following each dose, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL total weight-based maximum.

Group II: Participants aged 2 to <4 years: CLENPIQ Experimental Treatment 1 Intervention

CLENPIQ administered using "split-dose" method and consists of two separate doses: the first dose (½ bottle \[approximately 80 mL\]) one day before colonoscopy between 5:00 PM and 9:00 PM, and the second dose (½ bottle \[approximately 80 mL\]) the next day, at least 5 hours prior but no more than 9 hours prior to the colonoscopy. Following each dose, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL.

Group III: Participants aged 2 to <4 years: MIRALAX Active Control 1 Intervention

MIRALAX 3.4 to 4.9 g/kg up to a maximum of 238 g is reconstituted with non-carbonated, clear beverage, or water and administered in increments of 4 ounce (oz) for every 30 minutes, one day before colonoscopy between 5:00 PM and 9:00 PM. Following dosing, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL total weight-based maximum.

Group IV: Participants aged 4 to <9 years: MIRALAX Active Control 1 Intervention

MIRALAX 3.4 to 4.9 g/kg up to a maximum of 238 g is reconstituted with non-carbonated, clear beverage, or water and administered in increments of 8 oz for every 30 minutes one day before colonoscopy between 5:00 PM and 9:00 PM. Following dosing, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL total weight-based maximum.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Vanderbilt University Medical Center Nashville, TN

Ferring Investigational Site San Diego, CA

Ferring Investigational Site Bronx, NY

GI for Kids Knoxville, TN

More Trial Locations

Who Is Running the Clinical Trial?

Ferring Pharmaceuticals

Lead Sponsor

Trials

323

Patients Recruited

1,242,000+

Findings from Research

In a study of 778 average-risk individuals aged 50 and older, the combination of MiraLAX, Gatorade, and bisacodyl resulted in a higher rate of excellent or good bowel cleansing (93.3%) compared to the traditional 4-liter GoLytely (89.3%), indicating its efficacy as a bowel preparation method.

No serious adverse events were reported, suggesting that the MiraLAX combination is a safe alternative for bowel cleansing prior to colonoscopy, especially in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MiraLAX-Gatorade bowel prep versus GoLytely before screening colonoscopy: an endoscopic database study in a community hospital. Shieh, FK., Gunaratnam, N., Mohamud, SO., et al.[2022]

The new anti-hypersensitivity dentifrice has a low Relative Dentine Abrasivity (RDA) value of 34, indicating it is gentle on tooth surfaces while effectively treating dentinal hypersensitivity.

In in vitro tests, the dentifrice demonstrated superior stain removal compared to Sensodyne MultiCare and a conventional formulation, and performed similarly to Elmex Sensitive, suggesting it is effective for maintaining oral aesthetics without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The stain removal performance of a new anti-hypersensitivity dentifrice. Creeth, JE., Price, KS., Wicks, MA.[2006]

References

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

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

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

Bowel preparation before colonoscopy. Choosing the best lavage regimen. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: MiraLAX vs. Golytely - a controlled study of efficacy and patient tolerability in bowel preparation for colonoscopy. [2018]

4. Turkey 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®). [2020]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Predicting Inadequate Bowel Preparation When Using Sodium Picosulfate plus Magnesium Citrate for Colonoscopy: Development and Validation of a Prediction Score. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Efficacy, tolerability and safety of a split-dose bowel cleansing regimen of magnesium citrate with sodium picosulfate - a phase IV clinical observational study. [2022]

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

MiraLAX-Gatorade bowel prep versus GoLytely before screening colonoscopy: an endoscopic database study in a community hospital. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Stability of Silver and Fluoride Contents in Silver Diamine Fluoride Solutions. [2023]

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

Protective action of diosmectite treatment on digestive disturbances induced by intestinal anaphylaxis in the guinea-pig. [2019]

11. Singapore pubmed.ncbi.nlm.nih.gov

Effect of fluoridated gels on a light-cured glass ionomer cement: an SEM study. [2013]

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

The stain removal performance of a new anti-hypersensitivity dentifrice. [2006]

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

Clinical investigation of the antiplaque efficacy of a new variant of a commercially available triclosan/copolymer/fluoride dentifrice. [2016]