What side effects are associated with this type of intervention?

Common treatments for colon cleansing, such as osmotic laxatives like polyethylene glycol (PEG) and stimulant laxatives, are generally effective but can have side effects. PEG is often well-tolerated but may cause bloating, nausea, abdominal pain, and electrolyte imbalances. Stimulant laxatives can lead to abdominal cramping, dehydration, and electrolyte disturbances. Both types of laxatives can cause diarrhea, which is usually the intended effect but can be excessive in some cases, leading to dehydration and discomfort.

What prior FDA approvals exist?

Polyethylene glycol (PEG) solutions, such as PEG 3350, have been FDA-approved for bowel cleansing prior to colonoscopy. These solutions work by inducing bowel movements to evacuate the colon. Other FDA-approved agents for colon cleansing include sodium phosphate-based preparations and sulfate-based solutions. These treatments are designed to be effective and safe for clearing the bowel, ensuring optimal conditions for diagnostic procedures like colonoscopy.

What other types of research exist?

One promising novel alternative for bowel cleansing is the use of macrogol 3350 plus electrolytes (Movicol), which has been shown to be effective and well-tolerated. Additionally, the use of oscillatory positive expiratory pressure (OPEP) devices, although primarily used for respiratory conditions, has shown potential in enhancing mucociliary clearance and could be explored for bowel cleansing applications. Further research and clinical trials are needed to validate these alternatives for routine use in colon cleansing.

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Bowel Preparation with CLENPIQ vs. MIRALAX for Colon Cleansing (PICCOLO Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for colon cleansing include osmotic laxatives, stimulant laxatives, and saline laxatives. Osmotic laxatives, such as polyethylene glycol, work by drawing water into the colon, which softens the stool and stimulates bowel movements. Stimulant laxatives, like bisacodyl, act on the intestinal lining to increase muscle contractions, promoting stool evacuation. Saline laxatives, such as magnesium citrate, attract and retain water in the intestinal lumen, leading to bowel distension and peristalsis. These mechanisms are essential for effectively clearing the colon, ensuring that medical procedures like colonoscopies can be performed with optimal visibility and accuracy.

Phase 1 & 2

Recruiting

Research Sponsored by Ferring Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have had an average of three or more spontaneous bowel movements (SBM) per week for 1 month prior to the colonoscopy

Male or female, aged 2 years to <9 years being scheduled to undergo elective colonoscopy

Must not have

Clinically significant abdominal pain during the screening period

Severe acute inflammatory bowel disease (IBD) during the screening period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening (≤21 days before scheduled colonoscopy) up to day 28±7 after colonoscopy

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of both CLENPIQ and MIRALAX may include nausea, vomiting, abdominal pain, dehydration, and electrolyte disturbances. These products are used to empty the bowels so they might also cause discomfort like bloating or cramping.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I weigh at least 22 pounds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had significant stomach pain recently.

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I have severe IBD symptoms right now.

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I have a history of serious stomach or intestine problems.

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I have had neurological issues, possibly related to low sodium, recently.

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I have no major liver, heart, or kidney diseases.

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I have had surgery on my upper stomach area, but not for gallbladder removal.

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I have a history of specific colon diseases.

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I have had or currently have severe intestinal problems.

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I have had severe nausea or vomiting for a while now.

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I have had surgery for colorectal issues, but not for appendicitis or polyp removal.

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I do not have any urgent stomach surgery needs like blockages or holes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening (≤21 days before scheduled colonoscopy) up to day 28±7 after colonoscopy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening (≤21 days before scheduled colonoscopy) up to day 28±7 after colonoscopy

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (≤21 days before scheduled colonoscopy) up to day 28±7 after colonoscopy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants classified as responders, defined by "excellent" or "good" in the Modified Aronchick scale

Secondary study objectives

Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How did the bowel cleanout medicine taste?

Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How easy was it for you/the child to drink the bowel cleanout medicine?

Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How much were you/the child bothered by going to the bathroom since you/the child started the cleanout?

+12 more

Side effects data

From 2017 Phase 4 trial • 276 Patients • NCT03060512

Flatulence

Nausea

Abdominal pain

Urinary tract infection

Abdominal pain upper

Diarrhoea

Vertigo

Gastroenteritis

Laceration

Abdominal distension

Vomiting

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

PEG 3350

Movantik

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Participants aged 4 to <9 years: CLENPIQExperimental Treatment1 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: CLENPIQExperimental Treatment1 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: MIRALAXActive Control1 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: MIRALAXActive Control1 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.

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colon cleansing include osmotic laxatives, stimulant laxatives, and saline laxatives. Osmotic laxatives, such as polyethylene glycol, work by drawing water into the colon, which softens the stool and stimulates bowel movements. Stimulant laxatives, like bisacodyl, act on the intestinal lining to increase muscle contractions, promoting stool evacuation. Saline laxatives, such as magnesium citrate, attract and retain water in the intestinal lumen, leading to bowel distension and peristalsis. These mechanisms are essential for effectively clearing the colon, ensuring that medical procedures like colonoscopies can be performed with optimal visibility and accuracy.

Effects of oral laxatives on colonic motor complexes in dogs.Acute paraquat exposure impairs colonic motility by selectively attenuating nitrergic signalling in the mouse.Effect of short-chain fatty acids and acidification on the phasic and tonic motor activity of the human colon.