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Completed

NCT Number: NCT05581732

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for nutrition and biotechnology, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrinidrink with Dietary Fiber

Dietary Supplement

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

Primary outcomes

  1. BMI

    Time frame: during observation up to 16 weeks

    Body Mass Index

  2. Z-score (BMI)

    Time frame: during observation up to 16 weeks

    Body mass index z-scores are measures of relative weight adjusted for child age and sex

  3. Bioelectrical impedance analysis

    Time frame: 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

  4. Gastrointestinal symptoms scale

    Time frame: 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

  5. Martinet-Kushelevsky test

    Time frame: during observation up to 16 weeks

    Activity test to determine the level of physical abilities

Sponsors and collaborators

Lead sponsor

Enrollme.ru, LLC

Network

Collaborators

  • Danone Nutricia

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2022
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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