189 research outputs found
Dietary modification of atopic disease: Use of probiotics in the prevention of atopic dermatitis
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The design of probiotic studies to substantiate health claims
No full textThe EC Regulation No. 1924/2006 on Nutrition and Health claims made on foods has generated considerable debate and concern among scientists and industry. At the time of writing, the European Food Safety Authority (EFSA) has not approved any probiotic claims despite numerous human trials and meta-analyses showing evidence of beneficial effects. On 29th and 30th September 2010, ten independent, academic scientists with a documented record in probiotic research, met to discuss designs for future probiotic studies to demonstrate health benefits for gut and immune function. The expert panel recommended the following: (i) always formulate a precise and concrete hypothesis, and appropriate goals and parameters before starting a trial; (ii) ensure trials have sufficient sample size, such that they are adequately powered to reach statistically significant conclusions, either supporting or rejecting the a priori hypothesis, taking into account adjustment for multiple testing (this might necessitate more than one recruitment site); (iii) ensure trials are of appropriate duration; (iv) focus on a single, primary objective and only evaluate multiple parameters when they are hypothesis-driven. The panel agreed that there was an urgent need to better define which biomarkers are considered valuable for substantiation of a health claim. As a first step, the panel welcomed the publication on the day of the meeting of EFSA's draft guidance document on immune and gut health, although it came too late for study designs and dossiers to be adjusted accordingly. New validated biomarkers need to be identified in order to properly determine the range of physiological functions influenced by probiotics. In addition, validated biomarkers reflecting risk factors for disease, are required for article 14 claims (EC Regulation No. 1924/2006). Finally, the panel concluded that consensus among scientists is needed to decide appropriate clinical endpoints for trials
Changes in Healthy Infant Gut Microbiota over the Past Decades
No full textBifidobacteria typify the gut microbiota of healthy, breastfed infants. Altered gut microbiota composition in early infancy characterized by decreased Bifidobacterium abundance has been linked with a heightened risk of non-communicable diseases. Our goal was to assess factors impacting on the gut microbiota composition in infants throughout the allergy and obesity epidemics of the past decades.The study received funding from the Finnish Cultural Foundation, Avohoidon Tutkimussäätiö, Wellbeing Services County of Southwest Finland, and Research Council of Finland. IATA-CSIC authors (M.C.C. and M.B.-U.) would like to acknowledge the award of the Spanish government MCIN/AEI to the IATA-CSIC as Center of Excellence Accreditation Severo Ochoa (CEX2021-001189-S/MCIN/AEI/10.13039/501100011033).With funding from the Spanish government through the ‘Severo Ochoa Centre of Excellence’ accreditation (CEX2021-001189-S).Peer reviewe
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