← Back to Search

Dietary Supplement

Kiwifruit Extract for Constipation in Children

Hamilton, Canada

Phase 2 & 3

Waitlist Available

Led By Elyanne Ratcliffe, MD

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fulfill Rome IV diagnostic criteria for FC; 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

Be younger than 18 years old

Must not have

Organic causes of constipation (e.g., celiac disease, Hirschsprung's disease, spina bifida, anorectal malformations)

Prior abdominal surgery involving the luminal GI tract, except hernia repairs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Summary

This trial aims to see if Actazin (kiwifruit extract) is a good alternative to PEG 3350 for treating constipation in children. They will compare Actazin tablets

See full description

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects may include changes in stool frequency or consistency, abdominal pain, and potential reactions from daily use of either Actazin or PEG 3350 over four weeks, monitored through weekly follow-ups.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have chronic constipation based on specific symptoms.

show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have conditions like celiac or Hirschsprung's causing my constipation.

show original

Select...

I have had surgery on my digestive tract, not including hernia repairs.

show original

Select...

I cannot give consent because there's no translator for my language.

show original

Select...

I am taking medication that affects my stomach or bowel movements.

show original

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

4-week Follow up rates

Adherence to allocated intervention

Consent Rate

Secondary study objectives

Completion of daily bowel diary

Compliance rate

Eligibility criteria

+2 more

Other study objectives

Abdominal pain

Bloating

ROME IV criteria

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1Experimental Treatment2 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 2Active Control2 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.

0 / 5Eligibility criteria met