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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a natural kiwifruit extract, known as Actazin, can effectively treat functional constipation (FC) in children. The study compares Actazin chewable tablets with the commonly used PEG 3350 powder to determine if Actazin can serve as a viable alternative. Children experiencing symptoms of FC, such as infrequent bowel movements or painful stools, for at least a month may be suitable candidates for this trial. Participants will be randomly assigned to take either Actazin or PEG 3350 daily for four weeks, with progress monitored through a daily bowel diary and regular follow-ups.

As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to important advancements in pediatric care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that Actazin, a kiwifruit extract, is safe for adults. Specifically, taking 600 mg of Actazin daily improved stool consistency without causing serious side effects. However, limited information exists about its safety in children.

Polyethylene glycol 3350 (PEG 3350) is a common treatment for constipation, with substantial evidence showing its safety for children. It has been widely used and is generally well-tolerated.

The trial's advanced stage suggests that earlier research found Actazin reasonably safe. A Data Safety Monitoring Board (DSMB) will oversee safety to ensure participants' well-being. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for constipation?

Unlike the standard treatment for constipation in children, which often involves laxatives like PEG 3350, Actazin is derived from kiwifruit. This unique treatment utilizes a natural extract to potentially ease constipation, offering an alternative for those seeking plant-based solutions. Researchers are excited because Actazin's natural composition might provide a gentler option with fewer side effects. Additionally, its chewable tablet form could make it easier and more appealing for children to take compared to traditional liquid medications.

What evidence suggests that Actazin might be an effective treatment for functional constipation in children?

Research has shown that Actazin, a kiwifruit extract, can significantly aid people with constipation, including children, by increasing bowel movements. In previous studies, a daily intake of 600 mg of Actazin improved stool shape and consistency. Another review found that kiwifruit and its extracts, such as Actazin, relieve constipation by increasing the frequency of bowel movements. In this trial, one group of participants will receive Actazin chewable tablets, while another group will receive polyethylene glycol 3350 (PEG 3350), a well-known and effective treatment for constipation. The study aims to determine if Actazin can be a suitable option for children with functional constipation. ^{1 2 3 4 5}

Who Is on the Research Team?

Elyanne Ratcliffe, MD

Principal Investigator

Hamilton Health Sciences Corporation

Mohamed M Eltorki, MBChB, MSc

Principal Investigator

Hamilton Health Sciences Corporation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06836024?term=AREA%5BConditionSearch%5D(%22Constipation%22)&rank=6

A Trial of Actazin Versus PEG 3350 for Maintenance ... Secondary clinical outcomes include resolution of FC (Rome IV criteria), weekly stool frequency, abdominal pain episodes, use of rescue laxatives, and treatment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9560827/

Kiwifruit and Kiwifruit Extracts for Treatment of Constipation This systematic review aimed to summarize evidence to determine the effectiveness of kiwifruit or kiwifruit extracts in the treatment of constipation.

3. withpower.com withpower.com/trial/kiwifruit-extract-for-constipation-in-children-138da

Kiwifruit Extract for Constipation in Children Research shows that Actazin, a kiwifruit-derived supplement, significantly increased bowel movements in healthy adults and those with constipation. This ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212619824000366

Actazin® green kiwifruit powder consumption at 600 mg ... This study demonstrated that once daily supplementation of 600 mg Actazin green kiwifruit powder resulted in clinically significant improvements in stool form.

5. ctv.veeva.com ctv.veeva.com/study/a-trial-of-actazin-kiwifruit-extract-versus-polyethylene-glycol-3350-for-maintenance-therapy-in-ch

A Trial of Actazin Versus PEG 3350 for Maintenance Therapy ... This study will include children aged 4 to 17 years who meet the Rome IV criteria for functional constipation.