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NOT YET RECRUITING

NCT06836024

PHASE2/PHASE3

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

Sponsor: Hamilton Health Sciences Corporation

View on ClinicalTrials.gov

Summary

The goal of this pilot feasibility randomized controlled trial is to determine whether Actazin (kiwifruit extract) is a feasible and effective alternative to polyethylene glycol 3350 (PEG 3350) for maintenance therapy in children with functional constipation (FC). This study will include children aged 4 to 17 years who meet the Rome IV criteria for functional constipation. The main questions it aims to answer are: 1. Is it feasible to conduct a definitive, multi-centre trial comparing Actazin to PEG 3350 in children with FC? 2. What are the within-group differences in clinical outcomes such as stool frequency, abdominal pain, and laxative use over a 4-week period? Researchers will compare chewable Actazin tablets with placebo PEG 3350 powder to PEG 3350 powder with placebo Actazin tablets to see if Actazin is a viable non-pharmacologic natural health product alternative for treating FC. Participants will: Undergo an initial bowel cleanout using PEG 3350 and bisacodyl. Following, they will be randomized to one of two groups: 1. Actazin chewable tablets (titrate to effect: 600-2400 mg/day) + placebo PEG 3350 2. PEG 3350 (dose based on age and titratable to effect) + placebo Actazin chewable tablets Participants will take the assigned intervention daily for 4 weeks and complete a daily bowel diary recording stool frequency, consistency (Bristol Stool Scale), abdominal pain, and laxative use. They will have weekly follow-ups via phone or electronic survey to assess adherence, medication use, and adverse events. Additionally, a bi-weekly follow-up will be conducted for an additional 8 weeks to track longer-term outcomes. Outcomes: Primary feasibility outcomes include consent rate, adherence to allocated intervention, and 4-week follow-up completion rate. Secondary clinical outcomes include resolution of FC (Rome IV criteria), weekly stool frequency, abdominal pain episodes, use of rescue laxatives, and treatment palatability. This study is being conducted at McMaster Children's Hospital and is funded by the Hamilton Academic Health Sciences Organization (HAHSO). Data collection will be managed using the Lumedi™ platform, and safety will be overseen by a Data Safety Monitoring Board (DSMB).

Official title: Actazin (Kiwifruit Extract) Versus Polyethylene Glycol 3350 for Maintenance Therapy in Children With Constipation: a Feasibility Randomized Control Trial

Key Details

Gender

All

Age Range

4 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-01

Completion Date

2027-02-01

Last Updated

2025-03-19

Healthy Volunteers

Conditions

Constipation - Functional Constipation Constipation Aggravated

Interventions

DIETARY_SUPPLEMENT

Actazin chewable tablet

Actazin tablets are tableted non-GMO, freeze-dried, green kiwifruit powder from 100% New Zealand-grown green kiwifruit. Currently, kiwifruit extracts (such as Actazin), are marketed in Canada as a natural supplement. It is safe, bioavailable, and has been previously shown to be well tolerated at doses up to 2400 mg.

DRUG

PEG 3350

a commonly used over the counter laxative in north America. A stool softener.

OTHER

Chewable Tablet

Sorbitol-based placebo chewable tablets made by Pharma NZ. Those tablets will have a similar appearance to active Actazin but will not taste the same. This is because the taste of Actazin is a non-altered natural kiwi taste. They will be administered in the same dose and manner as the active Actazin oral chewable tablets.

OTHER

Maltodextrin (Placebo)

Maltodextrin powder, administered in the same doses and manner as active PEG 3350 group.

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

Locations (1)

Hamilton Health Sciences

Hamilton, Ontario, Canada