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

NCT06836024 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 20240420-Kiwi
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is it feasible to conduct a definitive, multi-centre trial comparing Actazin to PEG 3350 in children with FC?
2. 2.What are the within-group differences in clinical outcomes such as stool frequency, abdominal pain, and laxative use over a 4-week period?
3. 3.Actazin chewable tablets (titrate to effect: 600-2400 mg/day) + placebo PEG 3350
4. 4.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.

Conditions

Constipation - Functional; Constipation; Constipation Aggravated

Keywords

Functional Constipation; Pediatric Constipation; Actazin; Kiwifruit Extract; Polyethylene Glycol 3350; Laxative Therapy; Randomized Controlled Trial; Feasibility Study; Non-Pharmacologic Treatment; Rome IV Criteria

Outcome Measures

Primary Outcomes (3)

• Consent Rate

  Total number consented / Total number eligible and approached for consent

  18 months

• 4-week Follow up rates

  Total number of participants who did not complete the 4-week outcome

  18 months

• Adherence to allocated intervention

  Total number of participants who received the intervention they were allocated and did not cross over / Total number of participants

  18 months

Secondary Outcomes (5)

• Recruitment rate

  18 months

• Eligibility criteria

  18 months

• Completion of daily bowel diary

  18 months

• Compliance rate

  18 months

• Palatability

  18 months

Other Outcomes (8)

• ROME IV criteria

  18 months

• proportion with clinical resolution of functional constipation

  18 months

• weekly frequencies of the itemized items in Rome IV criteria

  18 months

Study Arms (2)

Group 1

EXPERIMENTAL

Participants will receive Active Actazin chewable tablets and placebo maltodextrin powder resembling PEG 3350: 1. Actazin oral chewable tablets with a starting dose of 600 mg (1 tablet) and can be titrated up to 2,400 mg (4 tablets). 2. Placebo PEG 3350: Maltodextrin powder, administered in the same doses and manner as active PEG 3350 group.

Dietary Supplement: Actazin chewable tablet; Other: Maltodextrin (Placebo)

Group 2

ACTIVE COMPARATOR

Participants will receive active comparator as PEG 3350 with a placebo chewable tablet resembling Actazin: 1. PEG 3350 dissolved in 125-250 ml of cold water or juice (daily dose is age based: 4-5 years-2 tsp, 6-12 years-4 tsp; \>13 years-5 tsp) and can be titrated by 1 tsp (3.7 grams) daily.57 2. Placebo Actazin oral chewable tablets: 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.

Drug: PEG 3350; Other: Chewable Tablet

Interventions

Actazin chewable tablet DIETARY_SUPPLEMENT

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.

Group 1

PEG 3350 DRUG

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

Group 2

Chewable Tablet OTHER

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.

Group 2

Maltodextrin (Placebo) OTHER

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

Group 1

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• Prior abdominal surgery involving the luminal GI tract, except hernia repairs
• Concomitant use of drugs that are known to affect GI motility (e.g., opioids, domperidone, linaclotide)
• Prior neuropsychiatric or pervasive developmental disorders such as severe non-verbal ASD, major psychiatric disorders (bipolar disorder, schizophrenia, major depression)
• 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
• Absence of a parent/guardian for children who are not mature minors
• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Constipation

Interventions

polyethylene glycol 3350; maltodextrin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elyanne Ratcliffe, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

• Mohamed M Eltorki, MBChB, MSc

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Redjana Carciumaru, MD

CONTACT

905-521-2100; carciur@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: each participant will receive both interventions, one will be active and the other will be placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double dummy design

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

CA (1)