Study of the ONS "Nutrinidrink With Dietary Fiber" Use Effect on Some Health Indicators in Children With Cerebral Palsy
- Conditions
- Cerebral Palsy
- Interventions
- Dietary Supplement: Nutrinidrink with Dietary Fiber
- Registration Number
- NCT05581732
- Lead Sponsor
- Enrollme.ru, LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Nutrinidrink with Dietary Fiber 32 patients in the study group received supplemental nutritional support with ONS "Nutrinidrink with Dietary Fiber" in a pre-calculated amount daily throughout the study for 14-16 weeks. During the hospital stay, additional nutritional support was added to the patient's standard hospital diet (ATC table). On an outpatient basis, the patient received the required amount of ONS at his disposal and add it as a supplement to his/her usual and habitual diet between main meals.
- Primary Outcome Measures
Name Time Method BMI during observation up to 16 weeks Body Mass Index
Gastrointestinal symptoms scale during observation up to 16 weeks A patient reported 5 score questionnaire to evaluate frequency and severity of gastrointestinal symptoms with 1 - minimal symptom manifestation, 5 - maximal symptom manifestation
Martinet-Kushelevsky test during observation up to 16 weeks Activity test to determine the level of physical abilities
Z-score (BMI) during observation up to 16 weeks Body mass index z-scores are measures of relative weight adjusted for child age and sex
Bioelectrical impedance analysis during observation up to 16 weeks Device-based diagnostics to measure the voltage of weak electrical currents in order to calculate impedance (resistance) of the body
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
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, Russian Federation