Bhesania N, Cresci GAM A nutritional approach for managing irritable bowel syndrome. Curr Opin Pediatr. 2017 Oct;29(5):584-591. doi: 10.1097/MOP.0000000000000536.
Bonaccorsi G, Furlan F, Scocuzza M, Lorini C Adherence to Mediterranean Diet among Students from Primary and Middle School in the Province of Taranto, 2016-2018. Int J Environ Res Public Health. 2020 Jul 28;17(15):5437. doi: 10.3390/ijerph17155437.
Devanarayana NM, Rajindrajith S Irritable bowel syndrome in children: Current knowledge, challenges and opportunities. World J Gastroenterol. 2018 Jun 7;24(21):2211-2235. doi: 10.3748/wjg.v24.i21.2211.
Henry CJ Basal metabolic rate studies in humans: measurement and development of new equations. Public Health Nutr. 2005 Oct;8(7A):1133-52. doi: 10.1079/phn2005801.
Iaccarino Idelson P, Scalfi L, Valerio G Adherence to the Mediterranean Diet in children and adolescents: A systematic review. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):283-299. doi: 10.1016/j.numecd.2017.01.002. Epub 2017 Jan 12.
Orsso CE, Gonzalez MC, Maisch MJ, Haqq AM, Prado CM Using bioelectrical impedance analysis in children and adolescents: Pressing issues. Eur J Clin Nutr. 2022 May;76(5):659-665. doi: 10.1038/s41430-021-01018-w. Epub 2021 Oct 7.
Paduano D, Cingolani A, Tanda E, Usai P Effect of Three Diets (Low-FODMAP, Gluten-free and Balanced) on Irritable Bowel Syndrome Symptoms and Health-Related Quality of Life. Nutrients. 2019 Jul 11;11(7):1566. doi: 10.3390/nu11071566.
Saps M, Biring HS, Pusatcioglu CK, Mintjens S, Rzeznikiewiz D A comprehensive review of randomized placebo-controlled pharmacological clinical trials in children with functional abdominal pain disorders. J Pediatr Gastroenterol Nutr. 2015 May;60(5):645-53. doi: 10.1097/MPG.0000000000000718.
Saps M, Miranda A Gastrointestinal Pharmacology. Handb Exp Pharmacol. 2017;239:147-176. doi: 10.1007/164_2016_119.
Savino F, Cresi F, Grasso G, Oggero R, Silvestro L The Biagram vector: a graphical relation between reactance and phase angle measured by bioelectrical analysis in infants. Ann Nutr Metab. 2004;48(2):84-9. doi: 10.1159/000077042. Epub 2004 Feb 25.
WHO Multicentre Growth Reference Study Group WHO Child Growth Standards based on length/height, weight and age. Acta Paediatr Suppl. 2006 Apr;450:76-85. doi: 10.1111/j.1651-2227.2006.tb02378.x.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
