1.
Efficacy and Safety of the Adjuvant Use of Probiotic Bacillus clausii Strains in Pediatric Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study.
Vázquez-Frias, R, Consuelo-Sánchez, A, Acosta-Rodríguez-Bueno, CP, Blanco-Montero, A, Robles, DC, Cohen, V, Márquez, D, Perez, M
Paediatric drugs. 2023;25(1):115-126
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Plain language summary
Irritable bowel syndrome (IBS) is considered both a health and a socioeconomic burden. Curative treatment for IBS is currently not available and current management strategies vary. Gut microbiota dysbiosis is increasingly considered as a vital factor in the etiopathogenetic of IBS; thus, gut microbiota are a potential therapeutic target. The aim of this study was to investigate the efficacy and safety of Bacillus clausii plus conventional treatment, compared with placebo plus conventional treatment, in children with IBS in Mexico. This study is a phase III, multicentre, randomised, placebo-controlled, double-blind, parallel clinical trial. Patients (n=259) were centrally randomised 1:1 to treatment with either B. clausii or placebo. Results show that IBS symptom relief in children was very high in both groups (B. clausii and placebo). In fact, there weren’t any significant differences between groups for proportion of patients with clinical improvements at Week 8 or any of the key secondary endpoints. Furthermore, the adverse event profile was similar between groups. Authors conclude that their study was not able to demonstrate the efficacy of B. clausii as an adjuvant to conventional treatment of patients with IBS.
Abstract
OBJECTIVES Current irritable bowel syndrome (IBS) treatments have limited efficacy and probiotics like Bacillus clausii (B. clausii) were found to be effective in the management of several gastrointestinal disorders. This phase III trial assessed the efficacy and safety of adding B. clausii (four strains: O/C, N/R, SIN, T), versus placebo, to conventional treatment of pediatric IBS in Mexico. METHODS Patients aged 6-17 years 11 months with IBS (Rome IV) for at least 2 months were randomized to receive either B. clausii (oral suspension, total dose 4 billion spores/day) or placebo once daily for 8 weeks. All patients also received conventional treatment. The primary endpoint was the difference in the proportion of patients with clinical improvements at Week 8 (Global Assessment Questions [GAQ]). Secondary endpoints included responders by Subject's Global Assessment of Relief for Children with IBS (SGARC); number/consistency of stools; abdominal distention/bloating; abdominal pain/intensity; and IBS behavior. RESULTS 73.6% (95% confidence interval [CI] 67.3-80.0; B. clausii n = 129) and 78.5% (95% CI 72.5-84.4; placebo n = 130) of patients had symptom improvement (p = 0.8182). For Week 8 SGARC, 19.2% (B. clausii) and 20.9% (placebo) reported complete symptom relief. Stool evaluations, bloating, abdominal pain/intensity, and IBS behavior were similar between groups. Both treatments were well tolerated. CONCLUSION No significant differences in efficacy between B. clausii and placebo were demonstrated in addition to conventional treatment. The sample size calculation was based on an expected placebo/conventional treatment response of 30-40%. However, the actual treatment response observed was 80% and, thus, a study with larger population would be warranted. In addition, this study was conducted during the COVID-19 pandemic, when such controlled social conditions may have resulted in better diet, greater family stability, less psychological stress, and lower risk of infections exacerbating IBS, thereby improving symptoms in both groups. EUDRACT NUMBER 2018-004519-31.
2.
Latin American Considerations for Infant and Young Child Formulae.
Ladino, L, Sánchez, N, Vázquez-Frias, R, Koletzko, B
Nutrients. 2021;(11)
Abstract
Infant formula is the only acceptable substitute for breastmilk from 0 to 6 months old when human milk cannot be provided in sufficient amounts. Manufacturers have developed options that intend to meet the changing needs of the child aged from six to twelve months (follow-on formulae) and after the age of one year (young child formulae). The international code for marketing breast milk substitute stipulates standards for marketing practices of these products. In Latin America there are local variations of marketing practices. Novel marketing strategies such as advertising through social media and influencers pose new threats for breastfeeding success in Latin America. This review aims to examine variations in local regulations for marketing of infant formulae and to analyze the emerging phenomenon of influencer advertising. We reviewed the local norms for Latin American countries and examined differences and possible gaps. Emerging evidence of influencer marketing was explored. The results indicate that national regulations differ among Latin American countries, particularly with respect to product labelling and the requirement to use a local native language, highlighting the cost of the product, and different regulations prohibiting certain messages and illustrations. Regarding new marketing strategies, there is limited evidence on advertising infant formula through social media influencers, where different categories of marketing strategies can be described. More transparent reporting of social marketing by formula providers and more independent research on novel marketing strategies are needed.
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Dietary fiber and the microbiota: A narrative review by a group of experts from the Asociación Mexicana de Gastroenterología.
Abreu Y Abreu, AT, Milke-García, MP, Argüello-Arévalo, GA, Calderón-de la Barca, AM, Carmona-Sánchez, RI, Consuelo-Sánchez, A, Coss-Adame, E, García-Cedillo, MF, Hernández-Rosiles, V, Icaza-Chávez, ME, et al
Revista de gastroenterologia de Mexico (English). 2021;(3):287-304
Abstract
Dietary fiber intake is one of the most influential and efficacious strategies for modulating the gut microbiota. Said fiber can be digested by the microbiota itself, producing numerous metabolites, which include the short-chain fatty acids (SCFAs). SCFAs have local and systemic functions that impact the composition and function of the gut microbiota, and consequently, human health. The aim of the present narrative review was to provide a document that serves as a frame of reference for a clear understanding of dietary fiber and its direct and indirect effects on health. The direct benefits of dietary fiber intake can be dependent on or independent of the gut microbiota. The use of dietary fiber by the gut microbiota involves several factors, including the fiber's physiochemical characteristics. Dietary fiber type influences the gut microbiota because not all bacterial species have the same capacity to produce the enzymes needed for its degradation. A low-fiber diet can affect the balance of the SCFAs produced. Dietary fiber indirectly benefits cardiometabolic health, digestive health, certain functional gastrointestinal disorders, and different diseases.
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Mexican consensus on lysosomal acid lipase deficiency diagnosis.
Vázquez-Frias, R, García-Ortiz, JE, Valencia-Mayoral, PF, Castro-Narro, GE, Medina-Bravo, PG, Santillán-Hernández, Y, Flores-Calderón, J, Mehta, R, Arellano-Valdés, CA, Carbajal-Rodríguez, L, et al
Revista de gastroenterologia de Mexico (English). 2018;(1):51-61
Abstract
INTRODUCTION Lysosomal acid lipase deficiency (LAL-D) causes progressive cholesteryl ester and triglyceride accumulation in the lysosomes of hepatocytes and monocyte-macrophage system cells, resulting in a systemic disease with various manifestations that may go unnoticed. It is indispensable to recognize the deficiency, which can present in patients at any age, so that specific treatment can be given. The aim of the present review was to offer a guide for physicians in understanding the fundamental diagnostic aspects of LAL-D, to successfully aid in its identification. METHODS The review was designed by a group of Mexican experts and is presented as an orienting algorithm for the pediatrician, internist, gastroenterologist, endocrinologist, geneticist, pathologist, radiologist, and other specialists that could come across this disease in their patients. An up-to-date review of the literature in relation to the clinical manifestations of LAL-D and its diagnosis was performed. The statements were formulated based on said review and were then voted upon. The structured quantitative method employed for reaching consensus was the nominal group technique. RESULTS A practical algorithm of the diagnostic process in LAL-D patients was proposed, based on clinical and laboratory data indicative of the disease and in accordance with the consensus established for each recommendation. CONCLUSION The algorithm provides a sequence of clinical actions from different studies for optimizing the diagnostic process of patients suspected of having LAL-D.