ACTRN12618001447246已完成4 期
Efficacy of InferrinTM and lactoferrin on symptoms of Irritable Bowel Syndrome. A randomized double-blind placebo-controlled study.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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