Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001447246
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
28/08/2018
Date last updated
16/02/2022
Date data sharing statement initially provided
19/07/2019
Date results information initially provided
16/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of InferrinTM and lactoferrin on symptoms of Irritable Bowel Syndrome. A randomized double-blind placebo-controlled study.
Scientific title
Efficacy of InferrinTM and lactoferrin on symptoms of Irritable Bowel Syndrome. A randomized double-blind placebo-controlled study.
Secondary ID [1] 295414 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BEG-IBS18
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable bowel syndrome 308651 0
Condition category
Condition code
Oral and Gastrointestinal 307591 307591 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Inferrin™: 120mg of Inferrin™ (equal to 50mg of lactoferrin) (total of 240mg daily) in capsule form. InferrinT™ is a proprietary microencapsulated form of lactoferrin. Participants randomised to this group will be instructed intake 120mg Inferrin™ twice daily with food and 250mL water for 56 days.

Arm 2: 50mg of lactoferrin + 70mg micro-crystalline cellulose powder (total of 100mg and 140mg daily) in capsule form. Lactoferrin is a freeze-dried protein purified directly from premium quality, fresh bovine milk. Participants randomised to this group will be instructed to take 50mg lactoferrin + 70mg mirco-crystalline cellulose powder twice daily with food and 250mL water for 56 days.

Adherence will be monitored by trial product container/capsule return at the end of the trial.
Intervention code [1] 301721 0
Treatment: Drugs
Comparator / control treatment
The placebo product will be microcrystalline cellulose encapsulated in an opaque vegetable capsule. It will be produced to appear identical to the test product and dosed twice daily with food and 250mL water for 56 days.

Adherence will be monitored by trial product container/capsule return at the end of the trial.
Control group
Placebo

Outcomes
Primary outcome [1] 306568 0
Change in IBS-SSS (IBS Symptom severity scale) score
Timepoint [1] 306568 0
measured at baseline, day 28 and day 56 (primary timepoint) post commencement of intervention
Secondary outcome [1] 348901 0
Change in IBS-QOL scale score
Timepoint [1] 348901 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [2] 348902 0
stool consistency (IBS-D) measured using the Bristol Stool Form Scale
Timepoint [2] 348902 0
measured at baseline, day 28 and day 56 post commencement intervention
Secondary outcome [3] 348903 0
stool frequency (IBS-C) measured by increase of 1 or more complete spontaneous bowel movements per week using the Bristol Stool Scale
Timepoint [3] 348903 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [4] 348904 0
Blood chemistry measuring fasting glucose, total serum iron, serum ferritin and hemoglobin via blood test
Timepoint [4] 348904 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [5] 348905 0
blood analysis measuring interleukin 6
Timepoint [5] 348905 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [6] 348906 0
safety markers - Serum Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), Gamma-glutamyl transpeptidase (GGT) and full blood count via blood test
Timepoint [6] 348906 0
measured by baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [7] 348907 0
gut permeability via zonulin blood test
Timepoint [7] 348907 0
measured at baseline and day 56 post commencement of intervention
Secondary outcome [8] 348908 0
body mass index calculated using height (measured using stadiometer) and weight (using scales)
Timepoint [8] 348908 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [9] 348909 0
heart rate measured by heart rate monitor
Timepoint [9] 348909 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [10] 348910 0
blood pressure measure measured by blood pressure monitor
Timepoint [10] 348910 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [11] 348911 0
global tolerability measured on a 5-point Likert scale
Timepoint [11] 348911 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [12] 350602 0
blood analysis measuring high-sensitivity c-reactive protein
Timepoint [12] 350602 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [13] 350603 0
blood analysis interferon-gamma
Timepoint [13] 350603 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [14] 350604 0
blood analysis measuring tumor necrosis factor alpha
Timepoint [14] 350604 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [15] 350608 0
blood analysis measuring immunoglobulin
Timepoint [15] 350608 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [16] 350611 0
blood analysis measuring natural killer cell activity
Timepoint [16] 350611 0
measured at baseline, day 28 and day 56 post commencement of intervention
Secondary outcome [17] 350619 0
weight measured using scales
Timepoint [17] 350619 0
measured at baseline, day 28 and day 56 post commencement of intervention

Eligibility
Key inclusion criteria
Males and females 18 years and over
Patients meeting the Rome IV irritable bowel syndrome (IBS) diagnostic criteria. IBS is defined as recurrent abdominal pain or discomfort at least 1 days/week in last 3 months (onset at least 6 months ago) associated with two or more of the following:
Related to defecation
Associated with a change in frequency of stool
Associated with a change in form (appearance) of stool
Able to provide informed consent
Females using a prescribed form of birth control (e.g. oral contraceptive)
Normal dietary habits (no FODMAP diet, elimination diet, vegan diet, etc) with a minimum 2-month period of self-reported dietary stability.
Otherwise healthy
Agree to not use any other dietary supplements which may impact gastrointestinal tract function during the study period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intake of lactoferrin containing products including sports nutrition products within the last 2 years
Concomitant treatment during the study (including screening phase) with any medication that could influence the gastrointestinal
Regular intake of nonsteroidal anti-inflammatory drugs incl. COX-2-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily)
Regular intake of medications that could influence immune function
Patients with known hypersensitivity to any component of the trial drugs – including cow milk allergy
History of eating disorders
Patients with a history of diseases with abdominal symptoms that can resemble IBS
Presence of any other acute or chronic gastrointestinal disorder
History of abdominal surgery (cholecystectomy and appendectomy can be tolerated when performed at least one year previously)
Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function Malignancy) ?
Pregnant or breastfeeding mothers (females who cannot rule out or suspect they may be pregnant will be directed to their GP for a pregnancy blood test)
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) ?
Any condition which in the opinion of the investigator makes the participant unsuitable for ?inclusion
Participants who have participated in any other clinical trial during the past 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The potential participants are screened by the investigator for inclusion in the study. The eligible participants are enrolled by investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the
numbered containers labelled prior to delivery to investigational site. Product allocated as participants are enrolled in sequential order
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The initial randomisation code will be generated by Random Allocation Software and patients allocated to one of the two groups at time of enrolment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/07/2019
Actual
17/09/2019
Date of last participant enrolment
Anticipated
Actual
13/07/2021
Date of last data collection
Anticipated
Actual
7/10/2021
Sample size
Target
120
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 300002 0
Commercial sector/Industry
Name [1] 300002 0
Tatura Milk Industries Ltd
Country [1] 300002 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett Street
Newstead, QLD, 4006
Country
Australia
Secondary sponsor category [1] 299387 0
None
Name [1] 299387 0
Address [1] 299387 0
Country [1] 299387 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300856 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 300856 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 300856 0
Australia
Date submitted for ethics approval [1] 300856 0
21/08/2018
Approval date [1] 300856 0
22/01/2019
Ethics approval number [1] 300856 0

Summary
Brief summary
Approximately 120 adult male and female participants aged over 18 will be recruited from databases and public media outlets. Following preliminary screening via telephone, if eligible, potential participants will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a health assessment including lifestyle, current medications, weight and height assessment, blood pressure, heart rate, IBS questionnaires and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. A blood test will also be carried out.

Participants will take the allocated product daily for 56 days attend the study site at day 28 for a progress assessment. At this assessment, all baseline tests will be administered including the blood test.

On day 56, the participants will attend the study site and all baseline tests will be administered and blood samples will be collected. A final exit interview will also be undertaken.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85050 0
Dr David Briskey
Address 85050 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
Country 85050 0
Australia
Phone 85050 0
+61 421 784 077
Fax 85050 0
Email 85050 0
[email protected]
Contact person for public queries
Name 85051 0
Ms Amanda Rao
Address 85051 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
Country 85051 0
Australia
Phone 85051 0
+61 414 488 559
Fax 85051 0
Email 85051 0
[email protected]
Contact person for scientific queries
Name 85052 0
Ms Amanda Rao
Address 85052 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
Country 85052 0
Australia
Phone 85052 0
+61 414 488 559
Fax 85052 0
Email 85052 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be shared


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3228Ethical approval    375498-(Uploaded-18-07-2019-11-20-23)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.