drugset / Trial / NCT05648422
Effect of the Nutritional Support System on Neuromotor Alterations in Patients With Cerebral Palsy
RandomizedSequentialDouble-blindTreatment
Summary
Study to determine the impact of a nutritional support system (NSS) on neuromotor alterations in patients with cerebral palsy.
Timeline
- Start
- 2023-01-16
- Primary completion
- 2025-01
- Completion
- 2025-01
Publications
- Background Trotta T, Porro C, Cianciulli A, Panaro MA. Beneficial Effects of Spirulina Consumption on Brain Health. Nutrients. 2022 Feb 5;14(3):676. doi: 10.3390/nu14030676.
- Background Schweizer U, Fabiano M. Selenoproteins in brain development and function. Free Radic Biol Med. 2022 Sep;190:105-115. doi: 10.1016/j.freeradbiomed.2022.07.022. Epub 2022 Aug 10.
- Background Roy Sarkar S, Mitra Mazumder P, Chatterjee K, Sarkar A, Adhikary M, Mukhopadhyay K, Banerjee S. Saccharomyces boulardii ameliorates gut dysbiosis associated cognitive decline. Physiol Behav. 2021 Jul 1;236:113411. doi: 10.1016/j.physbeh.2021.113411. Epub 2021 Mar 31.
- Background Visco DB, Toscano AE, Juarez PAR, Gouveia HJCB, Guzman-Quevedo O, Torner L, Manhaes-de-Castro R. A systematic review of neurogenesis in animal models of early brain damage: Implications for cerebral palsy. Exp Neurol. 2021 Jun;340:113643. doi: 10.1016/j.expneurol.2021.113643. Epub 2021 Feb 23.
- Background Rubin DI. Needle Electromyography Waveforms During Needle Electromyography. Neurol Clin. 2021 Nov;39(4):919-938. doi: 10.1016/j.ncl.2021.06.003. Epub 2021 Aug 31.
- Background Le Roy C, Barja S, Sepulveda C, Guzman ML, Olivarez M, Figueroa MJ, Alvarez M. Vitamin D and iron deficiencies in children and adolescents with cerebral palsy. Neurologia (Engl Ed). 2021 Mar;36(2):112-118. doi: 10.1016/j.nrl.2017.11.005. Epub 2018 Jan 17. English, Spanish.
- Background Tinkov AA, Skalnaya MG, Skalny AV. Serum trace element and amino acid profile in children with cerebral palsy. J Trace Elem Med Biol. 2021 Mar;64:126685. doi: 10.1016/j.jtemb.2020.126685. Epub 2020 Nov 12.
- Background Huff TC, Sant DW, Camarena V, Van Booven D, Andrade NS, Mustafi S, Monje PV, Wang G. Vitamin C regulates Schwann cell myelination by promoting DNA demethylation of pro-myelinating genes. J Neurochem. 2021 Jun;157(6):1759-1773. doi: 10.1111/jnc.15015. Epub 2020 Apr 14.
- Background Sorrenti V, Castagna DA, Fortinguerra S, Buriani A, Scapagnini G, Willcox DC. Spirulina Microalgae and Brain Health: A Scoping Review of Experimental and Clinical Evidence. Mar Drugs. 2021 May 22;19(6):293. doi: 10.3390/md19060293.
- Background Eyles DW. Vitamin D: Brain and Behavior. JBMR Plus. 2020 Oct 18;5(1):e10419. doi: 10.1002/jbm4.10419. eCollection 2021 Jan.
- Background Kazmierczak-Siedlecka K, Ruszkowski J, Fic M, Folwarski M, Makarewicz W. Saccharomyces boulardii CNCM I-745: A Non-bacterial Microorganism Used as Probiotic Agent in Supporting Treatment of Selected Diseases. Curr Microbiol. 2020 Sep;77(9):1987-1996. doi: 10.1007/s00284-020-02053-9. Epub 2020 May 29.
- Background Sainz-Pelayo MP, Albu S, Murillo N, Benito-Penalva J. [Spasticity in neurological pathologies. An update on the pathophysiological mechanisms, advances in diagnosis and treatment]. Rev Neurol. 2020 Jun 16;70(12):453-460. doi: 10.33588/rn.7012.2019474. Spanish.
- Background Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.
- Background Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.
- Background Leal-Martinez F, Franco D, Pena-Ruiz A, Castro-Silva F, Escudero-Espinosa AA, Rolon-Lacarrier OG, Lopez-Alarcon M, De Leon X, Linares-Eslava M, Ibarra A. Effect of a Nutritional Support System (Diet and Supplements) for Improving Gross Motor Function in Cerebral Palsy: An Exploratory Randomized Controlled Clinical Trial. Foods. 2020 Oct 13;9(10):1449. doi: 10.3390/foods9101449.
- Background Choi S, Hong DK, Choi BY, Suh SW. Zinc in the Brain: Friend or Foe? Int J Mol Sci. 2020 Nov 25;21(23):8941. doi: 10.3390/ijms21238941.
- Background Santos HO, Teixeira FJ, Schoenfeld BJ. Dietary vs. pharmacological doses of zinc: A clinical review. Clin Nutr. 2020 May;39(5):1345-1353. doi: 10.1016/j.clnu.2019.06.024. Epub 2019 Jul 4.
- Background Hariharan S, Dharmaraj S. Selenium and selenoproteins: it's role in regulation of inflammation. Inflammopharmacology. 2020 Jun;28(3):667-695. doi: 10.1007/s10787-020-00690-x. Epub 2020 Mar 6.
- Background Calderon-Ospina CA, Nava-Mesa MO. B Vitamins in the nervous system: Current knowledge of the biochemical modes of action and synergies of thiamine, pyridoxine, and cobalamin. CNS Neurosci Ther. 2020 Jan;26(1):5-13. doi: 10.1111/cns.13207. Epub 2019 Sep 6.
- Background Michielsen M, Vaughan-Graham J, Holland A, Magri A, Suzuki M. The Bobath concept - a model to illustrate clinical practice. Disabil Rehabil. 2019 Aug;41(17):2080-2092. doi: 10.1080/09638288.2017.1417496. Epub 2017 Dec 17.
- Background Vinals-Labanino CP, Velazquez-Bustamante AE, Vargas-Santiago SI, Arenas-Sordo ML. Usefulness of Cerebral Palsy Curves in Mexican Patients: A Cross-Sectional Study. J Child Neurol. 2019 May;34(6):332-338. doi: 10.1177/0883073819830560. Epub 2019 Mar 11.
- Background Fragale N, Navarre N, Rogers J. General Nutrition for Children with Cerebral Palsy. In: Miller F, Bachrach S, Lennon N, O'Neil M, editors. Cerebral Palsy Cham: Springer International Publishing; 2019. p. 1-10.
- Background Steele KM, Munger ME, Peters KM, Shuman BR, Schwartz MH. Repeatability of electromyography recordings and muscle synergies during gait among children with cerebral palsy. Gait Posture. 2019 Jan;67:290-295. doi: 10.1016/j.gaitpost.2018.10.009. Epub 2018 Oct 22.
- Background Picon-Pages P, Garcia-Buendia J, Munoz FJ. Functions and dysfunctions of nitric oxide in brain. Biochim Biophys Acta Mol Basis Dis. 2019 Aug 1;1865(8):1949-1967. doi: 10.1016/j.bbadis.2018.11.007. Epub 2018 Nov 27.
- Background Kaur H, Bose C, Mande SS. Tryptophan Metabolism by Gut Microbiome and Gut-Brain-Axis: An in silico Analysis. Front Neurosci. 2019 Dec 18;13:1365. doi: 10.3389/fnins.2019.01365. eCollection 2019.
- Background Lu J, Claud EC. Connection between gut microbiome and brain development in preterm infants. Dev Psychobiol. 2019 Jul;61(5):739-751. doi: 10.1002/dev.21806. Epub 2018 Nov 20.
- Background Panti-May JA, Zonta ML, Cociancic P, Barrientos-Medina RC, Machain-Williams C, Robles MR, Hernandez-Betancourt SF. Occurrence of intestinal parasites in Mayan children from Yucatan, Mexico. Acta Trop. 2019 Jul;195:58-61. doi: 10.1016/j.actatropica.2019.04.023. Epub 2019 Apr 22.
- Background Bivona G, Gambino CM, Iacolino G, Ciaccio M. Vitamin D and the nervous system. Neurol Res. 2019 Sep;41(9):827-835. doi: 10.1080/01616412.2019.1622872. Epub 2019 May 30.
- Background Gasperi V, Sibilano M, Savini I, Catani MV. Niacin in the Central Nervous System: An Update of Biological Aspects and Clinical Applications. Int J Mol Sci. 2019 Feb 23;20(4):974. doi: 10.3390/ijms20040974.
- Background Ballaz SJ, Rebec GV. Neurobiology of vitamin C: Expanding the focus from antioxidant to endogenous neuromodulator. Pharmacol Res. 2019 Aug;146:104321. doi: 10.1016/j.phrs.2019.104321. Epub 2019 Jun 20.
- Background Heshmati J, Morvaridzadeh M, Maroufizadeh S, Akbari A, Yavari M, Amirinejad A, Maleki-Hajiagha A, Sepidarkish M. Omega-3 fatty acids supplementation and oxidative stress parameters: A systematic review and meta-analysis of clinical trials. Pharmacol Res. 2019 Nov;149:104462. doi: 10.1016/j.phrs.2019.104462. Epub 2019 Sep 26.
- Background Tamtaji OR, Heidari-Soureshjani R, Mirhosseini N, Kouchaki E, Bahmani F, Aghadavod E, Tajabadi-Ebrahimi M, Asemi Z. Probiotic and selenium co-supplementation, and the effects on clinical, metabolic and genetic status in Alzheimer's disease: A randomized, double-blind, controlled trial. Clin Nutr. 2019 Dec;38(6):2569-2575. doi: 10.1016/j.clnu.2018.11.034. Epub 2018 Dec 10.
- Background Sharma SK, Bansal MP, Sandhir R. Altered dietary selenium influences brain iron content and behavioural outcomes. Behav Brain Res. 2019 Oct 17;372:112011. doi: 10.1016/j.bbr.2019.112011. Epub 2019 Jun 15.
- Background Gao Z, Chen L, Xiong Q, Xiao N, Jiang W, Liu Y, Wu X, Hou W. Degraded Synergistic Recruitment of sEMG Oscillations for Cerebral Palsy Infants Crawling. Front Neurol. 2018 Sep 18;9:760. doi: 10.3389/fneur.2018.00760. eCollection 2018.
- Background Caramico-Favero DCO, Guedes ZCF, Morais MB. FOOD INTAKE, NUTRITIONAL STATUS AND GASTROINTESTINAL SYMPTOMS IN CHILDREN WITH CEREBRAL PALSY. Arq Gastroenterol. 2018 Oct-Dec;55(4):352-357. doi: 10.1590/S0004-2803.201800000-78.
- Background Guo YE, Suo N, Cui X, Yuan Q, Xie X. Vitamin C promotes oligodendrocytes generation and remyelination. Glia. 2018 Jul;66(7):1302-1316. doi: 10.1002/glia.23306. Epub 2018 Feb 9.
- Background Garcia-Sanchez SF, Gomez-Galindo MT, Guzman-Pantoja JE. [Botulinum toxin A and physical therapy in gait in cerebral palsy]. Rev Med Inst Mex Seguro Soc. 2017 Jan-Feb;55(1):18-24. Spanish.
- Background Westfall S, Lomis N, Kahouli I, Dia SY, Singh SP, Prakash S. Microbiome, probiotics and neurodegenerative diseases: deciphering the gut brain axis. Cell Mol Life Sci. 2017 Oct;74(20):3769-3787. doi: 10.1007/s00018-017-2550-9. Epub 2017 Jun 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitazoxanide | Other / unclassified | 7.5 mg/kg | — |