A Trial of Actazin Versus PEG 3350 for Maintenance Therapy in Children With Constipation
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age4-17
SponsorHamilton Health Sciences Corporation
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
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.
Disqualifiers
Organic causes of constipation (e.g., celiac disease, Hirschsprung's disease, spina bifida, anorectal malformations)
Prior enrollment in trial
Not toilet trained; significantly different FC phenotype than toilet trained children
Any known hypersensitivity to kiwifruit, latex, Actazin or PEG 3350
Trial design
Design model
Parallel
Treatments tested in this trial
Actazin chewable tablet
Dietary supplementActazin 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.
PEG 3350
Druga commonly used over the counter laxative in north America. A stool softener.
Chewable Tablet
Other interventionSorbitol-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.
Maltodextrin (Placebo)
Other interventionMaltodextrin powder, administered in the same doses and manner as active PEG 3350 group.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group 1Experimental treatment 2 interventions
Group B: Group 2Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Consent Rate
Total number consented / Total number eligible and approached for consent
Time frame
18 months2
4-week Follow up rates
Total number of participants who did not complete the 4-week outcome
Time frame
18 months3
Adherence to allocated intervention
Total number of participants who received the intervention they were allocated and did not cross over / Total number of participants
Time frame
18 monthsSecondary outcomes
1
Recruitment rate
Number of participants recruited/month
Time frame
18 months2
Eligibility criteria
Proportion who are being assessed and treated for constipation, but do not meet Rome IV criteria
Time frame
18 months3
Completion of daily bowel diary
Number of missing items on the data collection form / total number of variables collected
Time frame
18 months4
Compliance rate
Number of days participants took laxative / 28 days
Time frame
18 monthsOther outcomes
1
ROME IV criteria
FC resolution (not meeting Rome IV FC criteria) at 28 days (+/-3 days) of treatment
Time frame
18 months2
proportion with clinical resolution of functional constipation
weeks 1-3, not meeting Rome IV FC criteria
Time frame
18 months3
weekly frequencies of the itemized items in Rome IV criteria
Spontaneous Bowel Movements (SBMs) - Frequency per week Episodes of Fecal Incontinence - Number of occurrences per week Retentive Posturing (Withholding Behaviors) - Number of episodes per week Painful or Hard Bowel Movements - Number of painful stools per week Presence of a Large Fecal Mass in the Rectum - Identified through clinical exam (weekly assessment) History of Large-Diameter Stools that Can Obstruct the Toilet - Caregiver-reported frequency per week
Time frame
18 months4
Stool consistency
Daily Bristol Stool Scale score (1 to 7) Type 1: Separate hard lumps (like nuts, hard to pass) Type 2: Sausage-shaped but lumpy Type 3: Sausage-shaped with cracks on the surface Type 4: Smooth, soft, and sausage-like Type 5: Soft blobs with clear-cut edges (easy to pass) Type 6: Mushy, fluffy pieces with ragged edges Type 7: Completely liquid, no solid pieces
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov
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