The incidence of gastroenteritis has greatly reduced due to improved hygiene conditions in developing countries and the use of Rotavirus vaccine. However, still thousands of children die from gastroenteritis, most of them in poor countries. Yet gastroenteritis management is simple, inexpensive, and effective and is largely the same all over the world. Universal guidelines for gastroenteritis guide the management and include simple interventions put forward early in the course of the disease. Treatment includes rehydration, continuing oral feeding, and antiinfective drugs in selected clinical conditions related to the symptoms or to host-related risk, and possible additional drug treatment to reduce the duration and severity of symptoms. There may be minor geographical differences in the treatment applied due to health care organizations that do not substantially change the standard universal recommendations. Prevention is recommended with sanitation interventions and Rotavirus universal immunization. Implementation of those interventions through educational initiatives and local programs in target areas are needed. A series of recommendations for interventions, education, and research priorities are included here with the aim of reducing the burden of gastroenteritis, to be pursued by scientists, physicians, policy makers, and stakeholders involved. They include the need of recommendations for the management of gastroenteritis in malnourished children, in those with chronic conditions, in neonates, and in emergency settings. A reference system to score dehydration, the definition of optimal composition of rehydration solution and the indications for anti-infective therapy are also included. Rotavirus immunization should be actively promoted, and evidence-based guidelines should be universally implemented. Research priorities are also indicated.
Background and objectives: There is evidence that patients with irritable bowel syndrome (IBS) have a low degree of inflammation in the intestinal mucosa. The aim of the study was to evaluate theprofile of pro-and anti-inflammatory cytokinesin plasmain Mexican pediatric patients with IBS. Patients and methods: Fifteen patients with IBS according to Rome III criteria for childhood and 15 healthy children, matched by age and sex, were included in the study. Plasma levels of tumoral necrosis factor alpha (TNF-␣), interleukins 10 and 12 (IL-10, IL-12) and transforming growth factor beta (TGF-) were quantified and compared between groups. Results: Plasma levels of IL-10 were lower in patients with IBS (86.07 + 21.3 pg/mL vs. 118.71 + 58.62 pg/mL: P=.045) and IL-12 levels were higher in patients with IBS compared to the control group of healthy children (1,204.2 ± 585.9 pg/mL vs. 655.04 ± 557.80 pg/mL; P=.011). The IL-10/IL-12 index was lower in patients with IBS (0.097 ± 0.07 vs. 0.295 ± 0.336; P=.025). Plasma concentration of TGF- was higher in patients with IBS (545.67 ± 337.69 pg/mL vs. 208.48 ± 142.21 pg/mL; P=.001). There was no difference in plasma levels of TNF-␣ between groups.Proinflammatory and anti-inflammatory cytokine profile in pediatric patients with irritable bowel syndrome 7Conclusions: This study suggests that children with IBS have a state of altered immune regulation. This is consistent with the theory of low-grade inflammatory state in these patients. Further studies are needed to elucidate the role played by these cytokines, specifically TGF- in the pathogenesis of IBS. Síndrome de intestino irritable; Pediatría; Citocinas; Factor de crecimiento transformante beta Perfil de citocinas proinflamatorias y antiinflamatorias en pacientes pediátricos con síndrome de intestino irritable Resumen Antecedentes y objetivos: Existe evidencia de un grado bajo de inflamación a nivel de la mucosa intestinal en pacientes con síndrome de intestino irritable (SII). El objetivo del estudio fue evaluar el perfil de citocinas proinflamatorias y antinflamatorias en plasma en pacientes pediátricos mexicanos con SII. Pacientes y métodos: Quince pacientes con SII de acuerdo con los criterios de Roma III para pacientes pediátricos y 15 niños sanos, pareados por edad y sexo fueron incluidos en el estudio. Se cuantificaron en plasma y se compararon el factor de necrosis tumoral alfa (TNF-␣), las interleucinas 10 y 12 (IL-10, IL-12) y el factor de crecimiento transformante beta (TGF-). Resultados: Los niveles plasmáticos de IL-10 fueron menores en los pacientes con SII (86.07 + 21.3 pg/mL vs. 118.71 + 58.62 pg/mL; p = 0.045) y los niveles de IL-12 mayores en los pacientes con SII en comparación con el grupo control de niños sanos (1,204.2 ± 585.9 pg/mL vs. 655.04 ± 557.80 pg/mL; p = 0.011). El índice IL-10/IL-12 fue menor en los pacientes con SII (0.097 ± 0.07 vs. 0.295 ± 0.336; p = 0.025). La concentración en plasma de TGF- fue mayor en los pacientes con SII (545.67 ± 337.69 pg/mL vs. 208.48 ± 142.21 pg/mL; p = 0.001)....
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.
Supplementary Information
The online version contains supplementary material available at 10.1007/s40272-022-00536-9.
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