The Effect of a Marine Protein Hydrolysate Supplement on Inflammatory Markers, Microbiota Composition and Symptoms in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- IBS-SSS
研究概览
简要总结
The use of natural bioactive products for prevention and treatment of a wide spectrum of conditions, including gastrointestinal disorders and conditions is well known. Based on current evidences, the scientific validity of such products is limited. However, there is sufficient preliminary data to indicate that bioactive compounds may be novel for potentially clinical use, thus further clinical trials investigating effect are needed. This trial is meant to evaluate the effect of an marine protein hydrolysate (MPH) supplement on composition of microbiota, inflammatory markers and symptom severity in people diagnosed with irritable bowel syndrome.
详细描述
Previous studies performed in rodents have found that hydrolyzed proteins from fish alters the lipid and cholesterol metabolism, reduce plasma cholesterol and triglyceride levels and alters the fatty acid composition in liver and adipose tissue. Previous studies in humans have found marine peptides to have both antihypertensive and antioxidant effects. It is also suggested that fish protein hydrolysates may have an immunomodulating effect with beneficial properties in the intestine, and may prevent NSAID-induced injuries, change permeability in the gut and possibly prevent injurious conditions in the gut.
The evidence and knowledge are limited on the interaction between diet, gut microbiota and the influence of specific nutrients, as well as the impact of different sources of proteins on inflammation markers, gut microbiota and symptom severity in patients with irritable bowel syndrome (IBS). Different dietary sources of protein affect the diversity and composition of the human gut microbiota in different degree, demonstrated by a distinct gut bacteria profile observed between omnivores and vegetarians.The specific effect of marine peptides on human gut microbiota composition is as far as the investigators know, previously not investigated. Interestingly, novel results indicate that the presence of fish proteins in the diet have impact on both composition and activity of the gut microbiome, influencing the human microbiota composition.
The many benefits of expanding the utilization of marine products, the previous assumed beneficial intestinal effect and the increased interest in gut health and microbiota, as well as a great need for novel dietary treatment strategies for patients with irritable bowel syndrome (IBS) make this study warrant.
Aim with this trial is to evaluate the effect of an marine protein hydrolysate (MPH) supplement on composition of microbiota, inflammatory markers and symptom severity in human subjects diagnosed with IBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The provider of the dietary supplement deliver the supplement prepared and packed in equal bags (active/placebo) that we hand out to the participants in an randomized order.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Body mass index (BMI) 18-30 kg/m2
- •Irritable Bowel Syndrome (IBS) diagnosis according to Rome IV criteria
排除标准
- •Suspected allergies against fish or shellfish
- •Low or unstable blood pressure
- •Diabetes mellitus pharmacologically treated
- •Chronic diseases or therapies that are likely to interfere with the evaluation of study results such as known inflammation
- •Acute infections (may be reconsidered for inclusion at a later time)
- •Substance misuse
- •Inability or unwillingness to comply with the requirements of study procedures
- •Individuals in the middle of testing different dietary strategies for the treatment of IBS (such as the low-FODMAP diet) and/or not willing to/able to maintain a stable diet throughout the study period
- •Use of pro- or prebiotic supplements
- •Use of antibiotic treatment for the last 4 weeks
- •Immunocompromised patient defined as taking immuno-suppressive medications
结局指标
主要结局
IBS-SSS
时间窗: Before (baseline) and after intervention (6 weeks later).
A decrease of 50 points or more in IBS-SSS, which is a clinically meaningful improvement.The IBS-SSS is a 5-question survey that asks the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale. Scores on the IBS-SSS can range from 0 to 500 with higher scores indicating more severe symptoms. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (\>300) IBS.
次要结局
- SF-NDI_HRQOL(Before (baseline) and after intervention (6 weeks later).)
- Fecal Calprotectin(Before (baseline) and after intervention (6 weeks later).)