Marine Protein Hydrolysate as Dietary Supplement in Irritable Bowel Syndrome (MPH_IBS)

Helse Møre og Romsdal HF

Status

Completed

Conditions

Irritable Bowel Syndrome

Treatments

Dietary Supplement: MPH_active

Dietary Supplement: MPH_placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03801057

2018/1825

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed informed consent
Body mass index (BMI) 18-30 kg/m2
Irritable Bowel Syndrome (IBS) diagnosis according to Rome IV criteria

Exclusion criteria

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