Efficacy of ActiPhen™ on gastrointestinal tract function in otherwise healthy adults. A randomised double blind placebo-controlled study.

Phase 3

Completed

• Conditions: gastrointestinal tract function; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12618000875202
• Lead Sponsor: RDC Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-23
• Study Completion: 2019-12-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Males and females aged over 18 years
- Females using a prescribed form of birth control (e.g. oral contraceptive)
- Experiencing three or more of the following symptoms of gastrointestinal discomfort including bloating, flatulence, diarrhoea, constipation, reflux, heart burn, abdominal pain/discomfort experienced at least 3 days in the last month
- Normal dietary habits (no FODMAP diet, elimination diet, vegan diet, etc) with a minimum 2 month period of self-reported dietary stability.
- Agree to not change current diet or exercise regime during entire study period
- Agree to not use any other dietary supplements or digestive enzymes during the study period
- Able to provide informed consent

Exclusion Criteria

- Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland
function Malignancy)
- People with a past or current history of inflammatory bowel disease or gastrointestinal tract
surgery
- Pregnant or breastfeeding mothers
- Malignancy or treatment for malignancy within the previous 2 years
- Receiving/ prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other
anticoagulation therapy including low dose aspirin
- Active smokers, nicotine, alcohol, drug abuse
- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- Allergic to any of the ingredients in active or placebo formula
- Any history of kiwi fruit allergy
- Those suffering from insomnia or have night-shift employment and unable to have a normal
night’s sleep
- People suffering any neurological disorders such as MS
- Any condition which in the opinion of the investigator makes the participant unsuitable for
inclusion (including hypercholesterolemia)
- Participants who have participated in any other clinical trial during the past 3 months
- Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
- History of infection in the month prior to the study or taking antibiotic therapy
- Hydration therapy during study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in gastrointestinal tract function as assessed by stool frequency via a daily diary[Baseline, week 3 and 6 (end point)]