A Trial of Actazin Versus PEG 3350 for Maintenance Therapy in Children With Constipation

Launched by HAMILTON HEALTH SCIENCES CORPORATION · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is examining whether a natural product called Actazin, which is made from kiwifruit, is an effective and practical alternative to a common laxative called PEG 3350 for treating functional constipation in children aged 4 to 17. The study aims to find out if it's possible to conduct a larger trial comparing these two treatments and to look at how well each option works over a 4-week period. Children who join the trial will first undergo a bowel cleanout and then be randomly assigned to take either Actazin chewable tablets along with a placebo (a non-active product) or PEG 3350 with a placebo tablet. They will keep a daily diary about their bowel movements and any discomfort, and they'll have regular check-ins to monitor their progress.

To be eligible for the trial, children must be between 4 and 17 years old and meet specific criteria for functional constipation, such as having infrequent bowel movements or painful stools. Parents will need to agree to use only the treatments provided during the study and not any other laxatives. This trial will take place at McMaster Children's Hospital, and safety measures will be in place to ensure participants’ well-being throughout the study. If you're considering participation or want to learn more, please reach out to the study team for further information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 4 to 17 years, inclusive; minimum age of 4 years to ensure toileting skills have been acquired and ability to chew and swallow tablets safely.
• • 2. Fulfill Rome IV diagnostic criteria for FC;60 Must include ≥2 of the following occurring at least once per week for a minimum of 1 month: (i) ≤2 SBMs/ week; (ii) ≥1 episode of fecal incontinence/week; (iii) retentive posturing; (iv) painful or hard bowel movements; (v) presence of a large fecal mass in the rectum (rectal, abdominal or radiographic exam) and (vi) history of large-diameter stools that can obstruct the toilet.
• • 3. Participant and their caregivers agree to exclusively use the laxatives provided as part of the trial for a 4-week period, and refrain from using any additional PEG 3350 or kiwifruit/kiwifruit extracts outside of the trial products.
• Exclusion Criteria:
• • 1. Organic causes of constipation (e.g., celiac disease, Hirschsprung's disease, spina bifida, anorectal malformations)
• • 2. Prior enrollment in trial
• • 3. Not toilet trained; significantly different FC phenotype than toilet trained children
• • 4. Any known hypersensitivity to kiwifruit, latex, Actazin or PEG 3350
• • 5. Chronic health conditions (e.g., urolithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially confound the results of the study
• • 6. Prior abdominal surgery involving the luminal GI tract, except hernia repairs
• • 7. Concomitant use of drugs that are known to affect GI motility (e.g., opioids, domperidone, linaclotide)
• • 8. Prior neuropsychiatric or pervasive developmental disorders such as severe non-verbal ASD, major psychiatric disorders (bipolar disorder, schizophrenia, major depression)
• • 9. Refractory or severe FC that failed to respond to PEG 3350 and/or require combination of several laxative therapies, manual disimpaction, use of any nerve stimulation or antegrade enemas through a cecostomy or an appendicostomy
• • 10. Absence of a parent/guardian for children who are not mature minors
• • 11. Inability to obtain consent due to a language barrier and the absence of language translator in person or by a phone translation service available in the ED