Efficacy of InferrinTM and lactoferrin on symptoms of Irritable Bowel Syndrome. A randomized double-blind placebo-controlled study.

Phase 4

Completed

• Conditions: Irritable bowel syndrome; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12618001447246
• Lead Sponsor: RDC Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-28
• Study Completion: 2021-10-07
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

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

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

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

• Study Type: Interventional
• Study Design: Not specified