Irritable Bowel Syndrome Clinical Trial
Official title:
The Effect of a Marine Protein Hydrolysate Supplement on Inflammatory Markers, Microbiota Composition and Symptoms in Patients With Irritable Bowel Syndrome
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.
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.
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