Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial.

BACKGROUND: The microorganism present in breast milk, added to other factors, determine the colonization of infants. The objective of the present study is to evaluate the safety, tolerance and effects of the consumption of a milk formula during the first year of life that is supplemented with L. fermentum CECT5716 or Bifidobacterium breve CECT7263, two strains originally isolated from breast milk. METHODS: A randomized, double blind, controlled, parallel group study including healthy, formula-fed infants was conducted. Two hundred and thirty-six 1-month-old infants were selected and randomly divided into three study groups according to a randomization list. Infants in the control group received a standard powdered infant formula until 12 months of age. Infants in the probiotic groups received the same infant formula but supplemented with L. fermentum CECT5716 Lc40 or B. breve CECT7263. Main outcome was weigh-gain of infants as safety marker. RESULTS: One hundred and eighty-nine infants completed the eleven months of intervention (61 in control group, 65 in Lf group and 63 in Bb group). The growth of infants in the three groups was consistent with standards. No significant differences were observed in the main outcome, weight-gain (Control group: 5.77 Kg ± 0.95, Lf group: 5.77 Kg ± 1.31, Bb group: 5.58 Kg ± 1.10; p = 0.527). The three milk formulae were well tolerated, and no adverse effects were related to the consumption of any of the formula. Infants receiving B. breve CECT7263 had a 1.7 times lower risk of crying than the control group (OR = 0.569, CI 95% 0.568-0.571; p = 0.001). On the other hand, the incidence of diarrhoea in infants receiving the formula supplemented with L. fermentum CECT5716 was a 44% lower than in infants receiving the control formula (p = 0.014). The consumption of this Lactobacillus strain also reduced the duration of diarrhoea by 2.5 days versus control group (p = 0.044). CONCLUSIONS: The addition of L. fermentum CECT5716 Lc40 or B. breve CECT7263, two probiotic strains naturally found in breast milk, to infant formulae is safe and induces beneficial effects on the health of infants. TRIAL REGISTRATION: The trial was retrospectively registered in the US Library of Medicine ( www.clinicaltrial.gov ) with the number NCT03204630 . Registered 11 August 2016.

Stromal tumors of the stomach. Review of our experience and reclassification of a series of patients.

OBJECTIVE: To retrospectively review a series of 12 patients operated on in our department for stromal tumor of the stomach. Clinical and morphological data, and the patients' postoperative course, were analyzed. METHODS: Medical records for 12 patients (mean age 63.3 years) were retrospectively reviewed to obtain data on clinical presentation, diagnosis and treatment. Surgical morbidity and mortality were analyzed. A pathologist reviewed the resected specimens to determine the morphological factors of prognostic value. The biological nature of the tumor was reclassified based exclusively on mitotic index, and all tumors were staged according to the TGM system. Recurrence and survival rates were also calculated. RESULTS: The most frequent clinical presentation was abdominal pain and gastrointestinal bleeding. The most sensitive diagnostic methods were computerized tomography and echographic endoscopy. Operability and resectability rates were 100% and 91.6% respectively. Local resection was done in 5 patients, partial gastrectomy in 5, and extended total gastrectomy in 1. Histologically, 6 cases were muscular tumors (2 leiomyomas, 3 low-grade leiomyosarcomas and 1 high-grade leiomyosarcoma), 2 were gastrointestinal autonomic nerve (GAN) tumors, and 4 were pure stomal tumors. The morbidity rate was 33.3% and the mortality rate was 8.3% (1 patient). All patients were followed up: 1 patient each died after 9 months and 4 years, 1 developed liver metastases after a disease-free interval of 14 months, and the other 9 patients were still alive and free of disease after intervals ranging from 4 months to 7 years. CONCLUSIONS: Stromal tumors include a group of tumors which may present muscular differentiation (the most frequent type), neural differentiation (GAN tumors) or no differentiation at all (pure stromal tumors). The mitotic index is the most valid parameter to determine biological nature, considering that classification as a benign tumor requires the total absence of mitoses. Treatment was mostly surgical, and local resection with adequate safety margins was effective. Prognosis was relatively good, but long-term follow-up is needed to assess the malignant potential of these tumors.

Tumores estromales gástricos. Revisión de nuestra experiencia y reclasificación de la serie / Stromal tumors of the stomach. Review of our experience and reclassification of a series of patients

OBJETIVO: el propósito del estudio es una revisión retrospectiva de una serie de 12 tumores estromales gástricos intervenidos en nuestro servicio, analizando tanto sus datos clínicos como sus características morfológicas y valorando el tratamiento quirúrgico y la evolución de los pacientes. PACIENTES Y MÉTODOS: se revisan las historias clínicas de todos los pacientes obteniendo datos de presentación clínica, diagnóstico y tratamiento; se analiza morbilidad y mortalidad. Paralelamente se revisan las piezas de anatomía patológica estudiando factores morfológicos de valor pronóstico y reclasificando el carácter biológico de los tumores en base exclusivamente al índice mitótico. Se estadifica la serie según el sistema TGM. Se analiza la tasa de recurrencia y supervivencia. RESULTADOS: la edad media de los pacientes fue de 63,3 años. La forma más frecuente de presentación clínica fue el dolor abdominal y la hemorragia digestiva. Los métodos diagnósticos más sensibles fueron CT y ecoendoscopia. La operabilidad fue del 100 por ciento y la resecabilidad del 91,6 por ciento, se realizó resección local en cinco pacientes, gastrectomía parcial en cinco casos y una gastrectomía total ampliada. Histológicamente seis casos fueron tumores musculares (dos leiomiomas, tres leiomiosarcomas de bajo grado y un leiomiosarcoma de alto grado), hubo dos tumores GAN y cuatro estromales puros. La morbilidad fue del 33,3 por ciento y la mortalidad del 8,3 por ciento (un caso). El seguimiento se llevó a cabo en el 100 por ciento de los casos: dos pacientes fallecieron (a los nueve meses y a los cuatro años respectivamente), un paciente desarrolló metástasis hepáticas (tras un intervalo libre de 14 meses) y el resto están vivos y libres de enfermedad con un rango entre cuatro meses y siete años. CONCLUSIONES: los tumores estromales incluyen un grupo de tumores que pueden presentar diferenciación muscular (los más frecuentes), diferenciación neural (tumores GAN) o ninguna diferenciación (tumores estromales puros). El índice mitótico es el criterio diferencial más válido para determinar su carácter biológico, considerándose que el criterio de benignidad exige la ausencia total de mitosis. El tratamiento se basa fundamentalmente en la cirugía, siendo suficiente la resección local con márgenes de seguridad. El pronóstico es relativamente bueno, siendo necesarios seguimientos a largo plazo para controlar la expresión de su potencia maligno (AU)