The effect of home-made gavage compared to commercial formula in children

The effect of home-made gavage in comparison with commercial formula on final outcomes, nutritional status and education level in 8-18 year old children.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231111060018N1

Enrollment

Registered

2025-03-13

Start date

2025-05-10

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral nutrition with homemade formula.

Interventions

Intervention 1: Intervention group: In the intervention group, daily calorie needs are first determined using the EER formula, and then, according to the individual's needs, a homemade formula with a

Eligibility

Sex/Gender

All

Age

8 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children 8 to 18 years old with a gastric peg or tube larger than size 14 Willingness to cooperate and complete the informed consent questionnaire by parents No hospitalization or ICU Stability of the individual's condition

Exclusion criteria

Exclusion criteria: All disorders that require a diet with limited macronutrient intake

Design outcomes

Primary

Measure	Time frame
Weight. Timepoint: The beginning and end of the intervention. Method of measurement: Weighing with a digital scale with high accuracy.;Height. Timepoint: The beginning and end of the intervention. Method of measurement: Using a standard meter.;Mid arm circumference. Timepoint: The beginning and end of the intervention. Method of measurement: Using a standard meter.	—

Secondary

Measure	Time frame
Inflammation status (High-sensitivity C-reactive protein). Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Oxidative stress status (Interleukin-6). Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Serum albumin index. Timepoint: At the beginning and end of the study. Method of measurement: Using laboratory methods.;Sodium. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Potassium. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Urea. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Creatinine. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Calcium. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Nutritional tolerance. Timepoint: At the beginning and end of the intervention. Method of measurement: Based on a checklist based on symptoms such as diarrhea, constipation, reflux, nausea and vomiting, and the amount of remaining stomach volume.;Zinc. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Ferritin. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Vitamin D. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.	—

Measure

Time frame

Inflammation status (High-sensitivity C-reactive protein). Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Oxidative stress status (Interleukin-6). Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Serum albumin index. Timepoint: At the beginning and end of the study. Method of measurement: Using laboratory methods.;Sodium. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Potassium. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Urea. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Creatinine. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Calcium. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Nutritional tolerance. Timepoint: At the beginning and end of the intervention. Method of measurement: Based on a checklist based on symptoms such as diarrhea, constipation, reflux, nausea and vomiting, and the amount of remaining stomach volume.;Zinc. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Ferritin. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.;Vitamin D. Timepoint: At the beginning and end of the intervention. Method of measurement: Using laboratory methods.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeedeh Talebi

Mashhad University of Medical Sciences

talebis@mums.ac.ir+98 51 3842 0718

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026