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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001447246

Acronym

BEG-IBS18

Enrollment

Registered

2018-08-28

Start date

2019-09-17

Completion date

2021-07-13

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results