Study of the ONS "Nutrinidrink With Dietary Fiber" Use Effect on Some Health Indicators in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Russian Prospective Open Comparative in Two Groups, Low-interventional Study on the Effect of the Oral Nutrition Supplement (ONS) "Nutrinidrink With Dietary Fiber" on the Health Indicators in Children With Cerebral Palsy (CP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05581732
• Other study ID #: NOCP
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: January 2023
• Source: Enrollme.ru, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this low-interventional study was to study the effect of additional nutritional support with ONS "Nutrinidrink with dietary fiber" on the anthropometric parameters of patients and the dynamics of gastrointestinal symptoms in patients with cerebral palsy. Among the additional objectives were to study the quality of life, metabolic parameters and the dynamics of some functional parameters of patients. Possible adverse events were also studied and described.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of cerebral palsy, spastic and hyperkinetic forms;
• Class of cerebral palsy GMFCS 2-3;
• Z-score BMI = -1;
• The patient's ability to safely swallow liquid food;
• Availability of informed consent signed by the patient's legal representative for inclusion in the study and processing of personal data.

Exclusion Criteria:

• Individual intolerance to the investigational product components;
• Galactosemia;
• Allergy to cow's milk proteins and other food intolerances;
• Participation in another clinical study currently or in the past 30 days;
• Any other medical or non-medical reason that, in the physician's opinion, may prevent the patient from participating in the study.
• Deterioration of the patient's condition requiring his transfer to enteral or parenteral nutrition;
• Transfer of a patient to another hospital;
• Complications that could be caused by the investigational product (diarrhea, nausea, vomiting, allergies, etc.);
• Withdrawal for a safety reason
• Refusal of the patient (his legal representative) from further participation in the study and withdrawal of informed consent to participate in the study and the processing of personal data. At the same time, the exclusion of a patient from the study should not affect the nature of his therapy

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Dietary Supplement:
• Nutrinidrink with Dietary Fiber
Nutrinidrink with Dietary Fiber is a specialized nutrition for children during illness and recovery period, as well as with increased protein and energy needs: mental and / or physical stress, chronic diseases, growth and / or weight deficiency

Locations

Country	Name	City	State
Russian Federation	Center for nutrition and biotechnology	Moscow
Russian Federation	Scientific and Clinical Center for Children's Psychoneurology	Moscow
Russian Federation	Child's Clinical Hospital by Ivanova	Samara

Sponsors (2)

Lead Sponsor	Collaborator
Enrollme.ru, LLC	Danone Nutricia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Body Mass Index	during observation up to 16 weeks
Primary	Z-score (BMI)	Body mass index z-scores are measures of relative weight adjusted for child age and sex	during observation up to 16 weeks
Primary	Bioelectrical impedance analysis	Device-based diagnostics to measure the voltage of weak electrical currents in order to calculate impedance (resistance) of the body	during observation up to 16 weeks
Primary	Gastrointestinal symptoms scale	A patient reported 5 score questionnaire to evaluate frequency and severity of gastrointestinal symptoms with 1 - minimal symptom manifestation, 5 - maximal symptom manifestation	during observation up to 16 weeks
Primary	Martinet-Kushelevsky test	Activity test to determine the level of physical abilities	during observation up to 16 weeks