Effectiveness of an amino acid beverage formulation in diarrheapredominant irritable bowel syndrome:A pragmatic real-world study

BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care.The primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product reported.Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.

New paradigm of oral rehydration in patients affected by irritable bowel syndrome with chronic diarrhea

Irritable bowel syndrome with diarrhea is a very frequent clinical condition characterized by disabling intestinal symptoms.This disease presents with daily abdominal pain for at least 3 months related to defecation and associated with a change in the frequency of bowel movements and the shape of the stool.International surveys about this disease report a global prevalence of about 1.5%.A new amino acid based electrolyte solution has recently been commercialized for oral rehydration in diarrhea.It is composed of water,electrolytes,and five selected amino acids that function as sodium co-transporters without containing glucose.In recent years,some studies explored the effectiveness of the amino acid based electrolyte beverage in oncologic patients with gastrointestinal mucositis,reporting good results.Recently,a prospective study to evaluate the clinical impact of the amino acid based medical beverage was conducted in patients with diarrhea predominant irritable bowel syndrome.The research was based on a real-life methodology minimizing the disruption of the routine care.One hundred patients suffering from irritable bowel syndrome with diarrhea drank a solution based on selected amino acids twice a day for 2 wk.Each enrolled patient completed the study and showed a significant response rate with regard to stool consistency and pain reduction.Based on this data,we can hypothesize that the amino acid based oral rehydration solution could be a valid tool in the treatment of patients affected by irritable bowel syndrome with diarrhea.It is certainly necessary to plan highquality clinical trials comparing glucose based oral solutions and amino acid based solutions in patients with persisting diarrhea.Probably in the near future all oral rehydration solutions will contain amino acids.

A Commercially Available Skin Care Lotion with a pH of 4.5 and 10% Urea Improves Skin Surface pH, Stratum Corneum Hydration and Epidermal Barrier Function in Subjects with Dry Skin and Atopic Diathesis

OBJECTIVE: The physiological skin surface pH is crucial for several epidermal barrier functions, like stratum corneum integrity, cohesion and restoration. Alterations of the “normal” acidic nature of the skin surface have been shown to correlate with specific skin conditions like aged or inflamed skin and are leading to impaired skin barrier function and formation. It is previously demonstrated that topical acidification in atopic dermatitis improves stratum corneum function, skin barrier structure and clinical signs in dermatitis. Against this background, we examined the impact of a slightly acidic skin care product containing urea on stratum corneum hydration, skin surface pH and epidermal barrier function in subjects with dry skin and atopic diathesis. METHODS: Stratum corneum hydration, skin surface pH and transepidermal water loss were biophysically measured before and after a 4-week treatment period with the test product (pH 4.5, 10% urea) compared to the reference product in 25 volunteers. In addition, dynamic epidermal barrier parameters like stratum corneum integrity, cohesion and recovery were investigated by using a previously described tape stripping approach. RESULTS: It was shown that the test product (pH 4.5, 10% urea) significantly elevated stratum corneum hydration and improved the acidic nature of the skin surface by lowering the skin surface pH to a greater extent compared to the reference product. After the 4-week treatment period a significant faster barrier restoration was detected on the test site treated with the test product compared to the reference product. Moreover, the test product strengthens the skin barrier integrity and cohesion. CONCLUSION: The present marketed skin care lotion was shown to increase epidermal barrier function after 4 weeks of application. Balancing and controlling the skin surface pH in subjects with dry and atopic-prone skin by application of the herein tested o/w emulsion with a given pH of 4.5, in combination with a 10% urea content seems to be effective and beneficial. The results are important for the formulation of topical products for dry and atopic-prone skin.