An Investigation into the Tolerability of Manuka Honey Cyclopower Trademark Chewable Tablets

Phase 2

Completed

• Conditions: Product tolerability; Effects on mouth microflora; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12613001349730
• Lead Sponsor: Manuka Health NZ Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Healthy subjects age 18 to 45 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs at screening.
Subjects must be non-smoking (no use of tobacco products in the previous 3 months).
Subjects must have a body mass index (BMI) within the range of 18 to 29 kg/m2.
Subjects of childbearing potential must be using an acceptable method of contraception for the duration of the study
Subjects must be willing to omit the following dietary products from their diet during screening and throughout the study: dietary prebiotic fibre/ probiotic dietary products, probiotic yoghurt (such as Yakult, Activate), oral probiotics such as BLIS, laxatives / enhanced dietary fibre products (such as Metamucil)
Subjects must be willing to omit the use of dental hygiene products the morning of saliva sample collection (randomisation and end of study) including brushing the teeth, use of mouth washes, antibacterial gum or lozenges.

Exclusion Criteria

A past medical history of clinically significant disease or abnormality including illnesses which affect the gastrointestinal and immune systems
Known allergy to any bee product or Honey Cyclopower
Known allergies or intolerance to fibre-based products
Known allergies or intolerance to xylitol or other ingredients in the study treatment
Have poor oral health as determined by the presence of significant halitosis, active dental cavities or significant gingivitis
Taken any antibiotics in the 3 months prior to screening
Use of any prescription drugs within 7 days prior to initial dosing in this study, other than occasional use of analgesics (less than 3 days in any 7-day period) and/ or hormonal contraceptives
Use of any recreational drugs in last 7 days prior to initial dosing in this study
Significant illness within 2 weeks prior to initial dosing in this study.
Dosing of a study drug in any clinical investigation within 30 days prior to initial dosing in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified