Kiwifruit Extract for Constipation in Children

Overseen By Redjana Carciumaru, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Hamilton Health Sciences Corporation

Must not be taking: Opioids, Domperidone, Linaclotide, others

Disqualifiers: Celiac, Hirschsprung's, Spina bifida, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants 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. If you are taking other medications that affect bowel movements, you may need to stop them, as the trial excludes those using drugs that affect GI motility.

What data supports the effectiveness of the treatment Actazin for constipation in children?

Research shows that Actazin, a kiwifruit-derived supplement, significantly increased bowel movements in healthy adults and those with constipation. This suggests it may help relieve constipation in children as well. ^{1 2 3 4 5}

Is kiwifruit extract safe for children?

There is no specific safety data available for kiwifruit extract or Actazin in children, but general safety in pediatric clinical trials emphasizes careful monitoring and understanding of potential adverse reactions. ^{6 7 8 9 10}

How does the treatment Actazin differ from other treatments for constipation in children?

Actazin, derived from kiwifruit, is unique because it uses natural ingredients to improve bowel movements by increasing stool frequency and enhancing stool form, unlike many synthetic laxatives. It is a dietary supplement that leverages the high fiber content and other functional components of kiwifruit, making it a gentle and natural option for alleviating constipation. ^{1 2 3 11 12}

What is the purpose of 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).

Research Team

Elyanne Ratcliffe, MD

Principal Investigator

Hamilton Health Sciences Corporation

Mohamed M Eltorki, MBChB, MSc

Principal Investigator

Hamilton Health Sciences Corporation

Eligibility Criteria

This trial is for children aged 4 to 17 with functional constipation, as defined by the Rome IV criteria. They must have completed an initial bowel cleanout using PEG 3350 and bisacodyl to participate. The study excludes those who do not meet these specific requirements.

Inclusion Criteria

I am between 4 and 17 years old and can use the toilet and swallow pills.

I have chronic constipation based on specific symptoms.

I agree to only use the trial's laxatives and avoid other PEG 3350 or kiwi products for 4 weeks.

Exclusion Criteria

Not toilet trained; significantly different FC phenotype than toilet trained children

Prior enrollment in trial

Any known hypersensitivity to kiwifruit, latex, Actazin or PEG 3350

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Bowel Cleanout

Participants undergo an initial bowel cleanout using PEG 3350 and bisacodyl before randomization

1 week

Treatment

Participants receive either Actazin chewable tablets with placebo PEG 3350 or PEG 3350 with placebo Actazin tablets for maintenance therapy

4 weeks

Weekly follow-ups via phone or electronic survey

Follow-up

Participants are monitored for longer-term outcomes, adherence, and clinical effects

8 weeks

Bi-weekly follow-ups

Treatment Details

Interventions

• Actazin

Trial Overview The trial tests if Actazin (kiwifruit extract) chewable tablets are a good alternative to PEG 3350 powder for long-term management of constipation in kids. It's a randomized controlled pilot study where participants also receive placebo versions of the treatment they're not being tested on.

Participant Groups

Group I: Group 1 Experimental Treatment 2 Interventions

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.

Group II: Group 2 Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

Findings from Research

Over a 38-month period, drug therapy was linked to an average of 243 reported deaths annually in infants and young children under 2 years old, with a significant number occurring in the first month and year of life.

A substantial portion of adverse events (24%) were associated with drug exposure from the mother during pregnancy, delivery, or lactation, highlighting the need for careful consideration of medication risks during this critical period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reported adverse drug events in infants and children under 2 years of age. Moore, TJ., Weiss, SR., Kaplan, S., et al.[2022]

The scoping review aimed to find practical guidance for establishing a pediatric safety specification in drug development but found no existing articles on the topic, highlighting a gap in the literature.

The review emphasizes that a well-defined pediatric safety specification is crucial for developing protocols that ensure safety monitoring, risk management, and appropriate pharmacokinetic studies in pediatric trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review. Aurich, B., Jacqz-Aigrain, E.[2021]

References

1. China pubmed.ncbi.nlm.nih.gov

Encapsulated green kiwifruit extract: a randomised controlled trial investigating alleviation of constipation in otherwise healthy adults. [2018]

2. Egypt pubmed.ncbi.nlm.nih.gov

Kiwifruit and Kiwifruit Extracts for Treatment of Constipation: A Systematic Review and Meta-Analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Kiwifruit-derived supplements increase stool frequency in healthy adults: a randomized, double-blind, placebo-controlled study. [2015]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Two Gold Kiwifruit Daily for Effective Treatment of Constipation in Adults-A Randomized Clinical Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Increasing dietary fiber intake in terms of kiwifruit improves constipation in Chinese patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Drug Reactions in Children: The Double-Edged Sword of Therapeutics. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Reported adverse drug events in infants and children under 2 years of age. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Metoclopramide-induced acute dystonic reaction: A pediatric case report. [2023]

10. Norway pubmed.ncbi.nlm.nih.gov

Safety in paediatric clinical trials--a 7-year review. [2022]

11. China pubmed.ncbi.nlm.nih.gov

Kiwifruit promotes laxation in the elderly. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

The Manufacturing Process of Kiwifruit Fruit Powder with High Dietary Fiber and Its Laxative Effect. [2020]