Cerebral PalsyNSS-PCNCT05648422
Effect of the Nutritional Support System on Neuromotor Alterations in Patients With Cerebral Palsy
A study testing Probiotics, NSS Nutritional Support System and Deworming in people with Cerebral Palsy and Spastic, run by Anahuac University at 1 site in Mexico.
Trial summary
Study to determine the impact of a nutritional support system (NSS) on neuromotor alterations in patients with cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Malnutrition
- What is being tested?
- Probiotics, NSS Nutritional Support System and Deworming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteMexico
- Study dates
- 16 Jan 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with GMFCS III classification.
- Patients with spastic CP.
- Both sexes age 4 to 11 years.
- Primary caregiver engaged (full presence).
- Able to follow instructions.
- Tolerant to oral feeding.
- Parents or guardians to sign informed consent letter.
- Children, if able to write, sign the letter of assent.
Who cannot join
- Have received antibiotics 15 days prior to treatment.
- Having received botulinum toxin therapy in the last six months. Consumption of muscle relaxants in the last three months.
- Patient with any type of surgery in a period of less than 6 months.
- Presence of any other catabolic disease, which further increases their risk of malnutrition (renal, cardiovascular, pulmonary, hepatic, immunological).
- Intolerance to oral feeding.
- Lack of stimulation at home.
- Moderate to severe gastroesophageal reflux.
- Able to walk without support.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Apac I.A.P. (Association For People With Cerebral Palsy)
México, 06720
Fernando Leal-Martínez, PhD, 5521094339, ferman5@hotmail.com
Mariana M Sarmiento, MD
About this study
Official title: Effect of the Nutritional Support System (NSS) on Neuromotor Alterations in Patients With Cerebral Palsy
Study to determine the impact of a nutritional support system (NSS) on neuromotor alterations in patients with cerebral palsy.
Read the detailed description
Cerebral Palsy (CP) is a group of motor disorders of the brain and can be accompanied by alterations in sensation, perception, cognition, communication and behavior, epilepsy and secondary musculoskeletal disorders. These disorders decrease daily functional performance in the areas of mobility, cognition and self-care, resulting in the need for a primary caregiver and increased health care costs. Rehabilitative treatment to increase functional independence is taken from the point of view of motor function (physiotherapy), however, no emphasis is placed on nutritional treatment aimed at alterations in mobility, cognition and self-care; currently it has been observed that eating disorders alter neuromuscular function directly or indirectly, therefore many patients do not respond adequately to treatment due to deterioration in secondary nutritional status. Dietary deficiency in patients with ICH is the result of the lack of an essential nutrient in the diet, each of these nutrients has a functional dynamic in the different stages, so that if one of them is missing or deficient, a functional or organic alteration, a biochemical variation or a disorder in body mass will occur. The World Health Organization (WHO) only considers energy, protein and fat requirements according to the age of the child. The NSS (Nutritional Support System) consisting of specific diet, supplementation (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, and inuline) and probiotics, have individually demonstrated effects such as neuronal regeneration, neuroprotective effect, reduction of oxidative stress.
A randomized, blinded, clinical trial will be conducted in children aged 4 to 11 years with CP functional level III of the Gross Motor Function Classification System (GMFCS), without impaired cognitive status and unable to walk on their own. They are randomly assigned to three groups: 1) follow-up group (GS) to which conventional diet (WHO) be applied; 2) control group 2 (GC) to which conventional diet (WHO), deworming and probiotics will be applied 3) intervention group (GI) deworming, probiotics, NSS supplements and specific diet will be applied, they will be followed up for three months; They will be evaluated at baseline, week 7 and week 13 with Gross Motor Function Measure 66 (GMFM-66) and MACS; at baseline and week 13 with kinetics and kinematic analysis, and electromyography (EMG). Statistical analysis: For the intragroup inferential statistical analysis, 2-way ANOVA will be used if the distribution is normal, otherwise FRIEDMAN will be used, in both cases post hoc tests will be applied; for the intergroup analysis, 1-way ANOVA will be used if the distribution is normal, otherwise KRUSKAL WALLIS will be used, in both cases post hoc tests will be applied.
- Conditions
- Cerebral Palsy, Spastic, Malnutrition
- Being tested
- Probiotics, NSS Nutritional Support System, Deworming, Specific diet, Conventional diet (WHO)
- Keywords
- Cerebral Palsy, Nutritional Support, NSS, Probiotics, Diet, Neurogenesis, Neuroplasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Also called Probiotics (Saccharomyces Boulardii)
Saccharomyces Boulardii 200 mg every 12 hours for 6 days at week 1, 5 and 9
NSS Nutritional Support SystemDietary supplement
Also called NSS
Nutritional Support System consists in NSS envelope (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, glycine, tryptophan, and inuline) every 12 hours for 12 weeks.
DewormingDrug
Also called Nitazoxanide
nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days
Specific dietOther
This diet focuses on meeting caloric needs according to age, weight, height, and stress factor dividing total caloric value in 50% carbohydrates, 30% lipids, and 20% proteins. It consists of smoothies at breakfast and dinner, high consumption of fish, five meals during the day, 70% of meals eaten during the day will consist on vegetables, fruits, roots, cereals, and legumes. Red meat, gluten, lactose, junk food, sugar, salt, fast food free.
Conventional diet (WHO)Other
This diet focuses on meeting caloric needs according to age, weight, height, and stress factor dividing total caloric value in 50% carbohydrates, 30% lipids, and 20% proteins. It consists of general nutricional recommendations.
| Study group | Role | What they receive |
|---|---|---|
| FG (FOLLOW GROUP) | No intervention | FG receive: Conventional diet (WHO). |
| CG (CONTROL GROUP) | Experimental | CG receive: Conventional diet (WHO), deworming (nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days), and probiotics (Saccharomyces Boulardii, 200 mg every 12 hours for 6 days at week 1, 5 and 9). Receives: Dietary Supplement: Probiotics; Drug: Deworming; Other: Conventional diet (WHO) |
| IG (INTERVENTION GROUP) | Experimental | IG receive: Deworming (nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days), probiotics (Saccharomyces Boulardii, 200 mg every 12 hours for 6 days at week 1, 5 and 9), specific diet, and NSS envelope (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, and inuline) every 12 hours for 12 weeks. Receives: Dietary Supplement: Probiotics; Dietary Supplement: NSS Nutritional Support System; Drug: Deworming; Other: Specific diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 7 WEEKS
It measures five mobility ability areas, known as dimensions: lying, sitting, crawling and kneeling, standing, and walking, running and jumping.
The main criterion is that the difference between each level is significant for daily living and these are based on functional limitations, support from gait aids such as crutches, canes, walkers or wheeled mobility.
It is intended to indicate at what level the child/youth's gross motor functioning abilities and limitations are at.
Measured: Baseline period, and week 7
CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 13 WEEKS
It measures five mobility ability areas, known as dimensions: lying, sitting, crawling and kneeling, standing, and walking, running and jumping.
The main criterion is that the difference between each level is significant for daily living and these are based on functional limitations, support from gait aids such as crutches, canes, walkers or wheeled mobility.
It is intended to indicate at what level the child/youth's gross motor functioning abilities and limitations are at.
Measured: Baseline period, and week 13
CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM AT 7 WEEKS
The Manual Ability Classification System (MACS) is a functional description and is also used to complement the child's diagnostic assessment giving a classification based on fine motor skills.
The MACS results are based on the child's performance in daily life, it does not take into account the differences between the function of the two hands; rather, it looks at how children handle age-appropriate objects and the need and extent of support or adaptations.
Measured: Baseline period, week 7
CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM 13 WEEKS
The Manual Ability Classification System (MACS) is a functional description and is also used to complement the child's diagnostic assessment giving a classification based on fine motor skills.
The MACS results are based on the child's performance in daily life, it does not take into account the differences between the function of the two hands; rather, it looks at how children handle age-appropriate objects and the need and extent of support or adaptations.
Measured: Baseline period, week 13
CHANGE FROM BASELINE MUSCLE ELECTRIC ACTIVITY AT 13 WEEKS
This study will measure the average behavior of a muscle or muscle group. It will give information on spasticity, coactivation of synergic and antagonic muscles, and maximum voluntary contraction.
The changes at muscle electric activity will be evaluated by applying electromyography (EMG) studies at baseline and at week 13.
Measured: Baseline and week 13
CHANGE FROM BASELINE GAIT ANALYSIS AT 13 WEEKS
This will provide objective and quantitative measures useful to assess gross motor skills with spatiotemporal, kinetics and kinematics data.
In each gait cycle it will measure walking speed, cadence, stride and step length and support, and joint angles.
The progression of the patient from the baseline period compared to week 13 will be evaluated with 3D motion capture systems.
Measured: Baseline and week 13
CHANGE FROM BASELINE CRAWLING ANALYSIS AT 13 WEEKS
This will provide objective and quantitative measures useful to assess gross motor skills with spatiotemporal, kinetics and kinematics data.
In each crawling analysis, speed, inter limb coordination and joint angles will be measured with 3D motion capture systems.
Measured: Baseline and week 13
Secondary outcomes (2)
CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 7 WEEKS
Midarm muscle area (MMA) will be calculated using the equation: [MCA - (π (TSF))^2]/4π) Mid upper arm circumference (MCA) will be measured in centimeters and the tricipital skinfold (TSF) will be measured using Harpenden skin fold caliper giving the measurements in millimeters.
Measured: Baseline and week 7
CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 13 WEEKS
Midarm muscle area (MMA) will be calculated using the equation: [MCA - (π (TSF))^2]/4π) Mid upper arm circumference (MCA) will be measured in centimeters and the tricipital skinfold (TSF) will be measured using Harpenden skin fold caliper giving the measurements in millimeters.
Measured: Baseline and week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start16 Jan 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, controlled clinical trial with blinding.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anahuac University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Leal-Martinez, Anahuac University
- Investigators
- Fernando Leal, PhD, Study director, Anahuac University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648422
- Sponsor's protocol ID
- 202082
- Acronym
- NSS-PC
- Status last verified
- Jan 2023
- First submitted
- 15 Feb 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
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.
PubMed 35277035Schweizer 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.
PubMed 35961466Roy 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.
PubMed 33811908Visco 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.
PubMed 33631199Rubin 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.
PubMed 34602219Le 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.
PubMed 29342407Tinkov 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.
PubMed 33249374Huff 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.
PubMed 32219848Sorrenti 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.
PubMed 34067317Eyles DW. Vitamin D: Brain and Behavior. JBMR Plus. 2020 Oct 18;5(1):e10419. doi: 10.1002/jbm4.10419. eCollection 2021 Jan.
PubMed 33553986Kazmierczak-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.
PubMed 32472262Sainz-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.
PubMed 32500524Sadowska 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.
PubMed 32606703Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.
PubMed 32053326Leal-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.
PubMed 33066040
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Nutritional Support System (NSS) on Neuromotor Alterations in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05648422
- Acronym / sponsor ID
- NSS-PC / 202082
- Conditions
- Cerebral Palsy, Spastic, Malnutrition
- Keywords
- Cerebral Palsy, Nutritional Support, NSS, Probiotics, Diet, Neurogenesis, Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Anahuac UniversityUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to determine the impact of a nutritional support system (NSS) on neuromotor alterations in patients with cerebral palsy.
Detailed description
Cerebral Palsy (CP) is a group of motor disorders of the brain and can be accompanied by alterations in sensation, perception, cognition, communication and behavior, epilepsy and secondary musculoskeletal disorders. These disorders decrease daily functional performance in the areas of mobility, cognition and self-care, resulting in the need for a primary caregiver and increased health care costs. Rehabilitative treatment to increase functional independence is taken from the point of view of motor function (physiotherapy), however, no emphasis is placed on nutritional treatment aimed at alterations in mobility, cognition and self-care; currently it has been observed that eating disorders alter neuromuscular function directly or indirectly, therefore many patients do not respond adequately to treatment due to deterioration in secondary nutritional status. Dietary deficiency in patients with ICH is the result of the lack of an essential nutrient in the diet, each of these nutrients has a functional dynamic in the different stages, so that if one of them is missing or deficient, a functional or organic alteration, a biochemical variation or a disorder in body mass will occur. The World Health Organization (WHO) only considers energy, protein and fat requirements according to the age of the child. The NSS (Nutritional Support System) consisting of specific diet, supplementation (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, and inuline) and probiotics, have individually demonstrated effects such as neuronal regeneration, neuroprotective effect, reduction of oxidative stress.
A randomized, blinded, clinical trial will be conducted in children aged 4 to 11 years with CP functional level III of the Gross Motor Function Classification System (GMFCS), without impaired cognitive status and unable to walk on their own. They are randomly assigned to three groups: 1) follow-up group (GS) to which conventional diet (WHO) be applied; 2) control group 2 (GC) to which conventional diet (WHO), deworming and probiotics will be applied 3) intervention group (GI) deworming, probiotics, NSS supplements and specific diet will be applied, they will be followed up for three months; They will be evaluated at baseline, week 7 and week 13 with Gross Motor Function Measure 66 (GMFM-66) and MACS; at baseline and week 13 with kinetics and kinematic analysis, and electromyography (EMG). Statistical analysis: For the intragroup inferential statistical analysis, 2-way ANOVA will be used if the distribution is normal, otherwise FRIEDMAN will be used, in both cases post hoc tests will be applied; for the intergroup analysis, 1-way ANOVA will be used if the distribution is normal, otherwise KRUSKAL WALLIS will be used, in both cases post hoc tests will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, controlled clinical trial with blinding.
| Arm | Type | Receives |
|---|---|---|
| FG (FOLLOW GROUP) | No intervention | –FG receive: Conventional diet (WHO). |
| CG (CONTROL GROUP) | Experimental | Dietary Supplement: Probiotics, Drug: Deworming, Other: Conventional diet (WHO)CG receive: Conventional diet (WHO), deworming (nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days), and probiotics (Saccharomyces Boulardii, 200 mg every 12 hours for 6 days at week 1, 5 and 9). |
| IG (INTERVENTION GROUP) | Experimental | Dietary Supplement: Probiotics, Dietary Supplement: NSS Nutritional Support System, Drug: Deworming, Other: Specific dietIG receive: Deworming (nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days), probiotics (Saccharomyces Boulardii, 200 mg every 12 hours for 6 days at week 1, 5 and 9), specific diet, and NSS envelope (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, and inuline) every 12 hours for 12 weeks. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Patients with GMFCS III classification.
- Patients with spastic CP.
- Both sexes age 4 to 11 years.
- Primary caregiver engaged (full presence).
- Able to follow instructions.
Key exclusion criteria (8 listed)
- Have received antibiotics 15 days prior to treatment.
- Having received botulinum toxin therapy in the last six months. Consumption of muscle relaxants in the last three months.
- Patient with any type of surgery in a period of less than 6 months.
- Presence of any other catabolic disease, which further increases their risk of malnutrition (renal, cardiovascular, pulmonary, hepatic, immunological).
- Intolerance to oral feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsAlso: Probiotics (Saccharomyces Boulardii)Saccharomyces Boulardii 200 mg every 12 hours for 6 days at week 1, 5 and 9 | Dietary supplement | CG (CONTROL GROUP), IG (INTERVENTION GROUP) |
| NSS Nutritional Support SystemAlso: NSSNutritional Support System consists in NSS envelope (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, glycine, tryptophan, and inuline) every 12 hours for 12 weeks. | Dietary supplement | IG (INTERVENTION GROUP) |
| DewormingAlso: Nitazoxanidenitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days | Drug | CG (CONTROL GROUP), IG (INTERVENTION GROUP) |
| Specific dietThis diet focuses on meeting caloric needs according to age, weight, height, and stress factor dividing total caloric value in 50% carbohydrates, 30% lipids, and 20% proteins. It consists of smoothies at breakfast and dinner, high consumption of fish, five meals during the day, 70% of meals eaten during the day will consist on vegetables, fruits, roots, cereals, and legumes. Red meat, gluten, lactose, junk food, sugar, salt, fast food free. | Other | IG (INTERVENTION GROUP) |
| Conventional diet (WHO)This diet focuses on meeting caloric needs according to age, weight, height, and stress factor dividing total caloric value in 50% carbohydrates, 30% lipids, and 20% proteins. It consists of general nutricional recommendations. | Other | CG (CONTROL GROUP) |
Primary outcome
CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 7 WEEKS
Time frame: Baseline period, and week 7
It measures five mobility ability areas, known as dimensions: lying, sitting, crawling and kneeling, standing, and walking, running and jumping. The main criterion is that the difference between each level is significant for daily living and these are based on functional limitations, support from gait aids such as crutches, canes, walkers or wheeled mobility. It is intended to indicate at what level the child/youth's gross motor functioning abilities and limitations are at.
CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 13 WEEKS
Time frame: Baseline period, and week 13
It measures five mobility ability areas, known as dimensions: lying, sitting, crawling and kneeling, standing, and walking, running and jumping. The main criterion is that the difference between each level is significant for daily living and these are based on functional limitations, support from gait aids such as crutches, canes, walkers or wheeled mobility. It is intended to indicate at what level the child/youth's gross motor functioning abilities and limitations are at.
CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM AT 7 WEEKS
Time frame: Baseline period, week 7
The Manual Ability Classification System (MACS) is a functional description and is also used to complement the child's diagnostic assessment giving a classification based on fine motor skills. The MACS results are based on the child's performance in daily life, it does not take into account the differences between the function of the two hands; rather, it looks at how children handle age-appropriate objects and the need and extent of support or adaptations.
CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM 13 WEEKS
Time frame: Baseline period, week 13
The Manual Ability Classification System (MACS) is a functional description and is also used to complement the child's diagnostic assessment giving a classification based on fine motor skills. The MACS results are based on the child's performance in daily life, it does not take into account the differences between the function of the two hands; rather, it looks at how children handle age-appropriate objects and the need and extent of support or adaptations.
CHANGE FROM BASELINE MUSCLE ELECTRIC ACTIVITY AT 13 WEEKS
Time frame: Baseline and week 13
This study will measure the average behavior of a muscle or muscle group. It will give information on spasticity, coactivation of synergic and antagonic muscles, and maximum voluntary contraction. The changes at muscle electric activity will be evaluated by applying electromyography (EMG) studies at baseline and at week 13.
CHANGE FROM BASELINE GAIT ANALYSIS AT 13 WEEKS
Time frame: Baseline and week 13
This will provide objective and quantitative measures useful to assess gross motor skills with spatiotemporal, kinetics and kinematics data. In each gait cycle it will measure walking speed, cadence, stride and step length and support, and joint angles. The progression of the patient from the baseline period compared to week 13 will be evaluated with 3D motion capture systems.
CHANGE FROM BASELINE CRAWLING ANALYSIS AT 13 WEEKS
Time frame: Baseline and week 13
This will provide objective and quantitative measures useful to assess gross motor skills with spatiotemporal, kinetics and kinematics data. In each crawling analysis, speed, inter limb coordination and joint angles will be measured with 3D motion capture systems.
2 secondary outcomes
CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 7 WEEKS
Time frame: Baseline and week 7
CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 13 WEEKS
Time frame: Baseline and week 13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 35277035Trotta 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: PubMed 35961466Schweizer 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.
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- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Leal, PhD study director
Anahuac University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics, NSS Nutritional Support System and Deworming in people with Cerebral Palsy and Spastic, run by Anahuac University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Leal, PhD (5521094339, ferman5@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 7 WEEKS (time frame: Baseline period, and week 7). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05648422, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.