Effects of biscuit supplementation fortified with zinc, glutamine, prebiotics, and dietary fiber on intestinal mucosal rehabilitation in children aged 12-18 months with undernutrition

Effects of biscuit supplementation fortified with zinc, glutamine, prebiotics, and dietary fiber on intestinal mucosal rehabilitation in children aged 12-18 months with undernutrition: A Study of Integrity of Intestinal Mucosa and Growth

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11266048

Enrollment

Registered

2018-01-09

Start date

2018-02-01

Completion date

Unknown

Last updated

2018-02-12

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

Conditions

Malnourishment Nutritional, Metabolic, Endocrine Malnourishment

Interventions

Interventions are performed by giving biscuits fortified with glutamine, zinc, prebiotics, and dietary fiber to the subjects. The subjects of 68 people are randomly allocated to one of two groups, nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 12-18 months 2. Malnutrition 3. Parents are willing to sign informed consent after being briefed and informed about the research;Inclusion criteria: 1. Age 12-18 months 2. Malnutrition 3. Parents are willing to sign informed consent after being briefed and informed about the research

Exclusion criteria

Exclusion criteria: Suffering from chronic illness (congenital heart disease, nephrotic syndrome, digestive problems, worms and other chronic diseases).;Exclusion criteria: Suffering from chronic illness (congenital heart disease, nephrotic syndrome, digestive problems, worms and other chronic diseases).

Design outcomes

Primary

Measure	Time frame
1. Improvement in intestinal integrity in undernourished children 12-18 months with improvement in markers of bowel integrity through examination of Intestinal Fatty Acid Binding Protein (IFABP), Alpha-1-Antitrypsin (AAT), and Calprotectin in children ages 12-18 months with malnutrition: 1.1. IFABP is measured using “urine” tests, ELISA method, at baseline, 3 months and 6 months 1.2. Calprotectin is measured using “stool” tests, ELISA method, at baseline, 3 and 6 months 1.3. AAT is measured using “stool” tests, ELISA method, at baseline, 3 and 6 months ;1. Improvement in intestinal integrity in undernourished children 12-18 months with improvement in markers of bowel integrity through examination of Intestinal Fatty Acid Binding Protein (IFABP), Alpha-1-Antitrypsin (AAT), and Calprotectin in children ages 12-18 months with malnutrition: 1.1. IFABP is measured using “urine” tests, ELISA method, at baseline, 3 months and 6 months 1.2. Calprotectin is measured using “stool” tests, ELISA method, at baseline, 3 and 6 months 1.3. AAT is measured using “stool” tests, ELISA method, at baseline, 3 and 6 months	—

Measure

Time frame

1. Improvement in intestinal integrity in undernourished children 12-18 months with improvement in markers of bowel integrity through examination of Intestinal Fatty Acid Binding Protein (IFABP), Alpha-1-Antitrypsin (AAT), and Calprotectin in children ages 12-18 months with malnutrition: 1.1. IFABP is measured using “urine” tests, ELISA method, at baseline, 3 months and 6 months 1.2. Calprotectin is measured using “stool” tests, ELISA method, at baseline, 3 and 6 months 1.3. AAT is measured using “stool” tests, ELISA method, at baseline, 3 and 6 months ;1. Improvement in intestinal integrity in undernourished children 12-18 months with improvement in markers of bowel integrity through examination of Intestinal Fatty Acid Binding Protein (IFABP), Alpha-1-Antitrypsin (AAT), and Calprotectin in children ages 12-18 months with malnutrition: 1.1. IFABP is measured using “urine” tests, ELISA method, at baseline, 3 months and 6 months 1.2. Calprotectin is measured using “stool” tests, ELISA method, at baseline, 3 and 6 months 1.3. AAT is measured using “stool” tests, ELISA method, at baseline, 3 and 6 months

—

Secondary

Measure	Time frame
1. Improvement in nutrient absorption, marked with improvement in Steatocrite level measured using “stool” tests, ELISA method at baseline, 3 and 6 months 2. Improvement in nutritional status. Nutritional status is based on improvement in Z-Score (WHZ and HAZ), measured at the end of every month during 6 months of intervention. Weight is measured using digital weight scale for children under 2 years old (brand will be confirmed later). Height is measured using manual height scale (brand will be confirmed later). WHZ and HAZ are calculated by Anthropometry Calculator Application published by WHO.;1. Improvement in nutrient absorption, marked with improvement in Steatocrite level measured using “stool” tests, ELISA method at baseline, 3 and 6 months 2. Improvement in nutritional status. Nutritional status is based on improvement in Z-Score (WHZ and HAZ), measured at the end of every month during 6 months of intervention. Weight is measured using digital weight scale for children under 2 years old (brand will be confirmed later). Height is measured using manual height scale (brand will be confirmed later). WHZ and HAZ are calculated by Anthropometry Calculator Application published by WHO.	—

Measure

Time frame

1. Improvement in nutrient absorption, marked with improvement in Steatocrite level measured using “stool” tests, ELISA method at baseline, 3 and 6 months 2. Improvement in nutritional status. Nutritional status is based on improvement in Z-Score (WHZ and HAZ), measured at the end of every month during 6 months of intervention. Weight is measured using digital weight scale for children under 2 years old (brand will be confirmed later). Height is measured using manual height scale (brand will be confirmed later). WHZ and HAZ are calculated by Anthropometry Calculator Application published by WHO.;1. Improvement in nutrient absorption, marked with improvement in Steatocrite level measured using “stool” tests, ELISA method at baseline, 3 and 6 months 2. Improvement in nutritional status. Nutritional status is based on improvement in Z-Score (WHZ and HAZ), measured at the end of every month during 6 months of intervention. Weight is measured using digital weight scale for children under 2 years old (brand will be confirmed later). Height is measured using manual height scale (brand will be confirmed later). WHZ and HAZ are calculated by Anthropometry Calculator Application published by WHO.

—

Countries

Indonesia

Contacts

Public Contact; ;

;

;;

Outcome results

None listed

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