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

• Register: ISRCTN
• Last refreshed on: 12 February 2018
• Main ID: ISRCTN11266048
• Date of registration: 09/01/2018
• Prospective Registration: Yes
• Primary sponsor: University Indonesia
• Public title: Effects of biscuit supplementation fortified with zinc, glutamine, prebiotics, and dietary fiber on intestinal mucosal rehabilitation in children aged 12-18 months with undernutrition
• Scientific title: 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
• Date of first enrolment: 01/02/2018
• Target sample size: 68
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11266048
• Study type: Interventional
• Study design: Interventional single-centered study (Treatment)

Countries of recruitment

Indonesia

Contacts

• Name: Eva Jeumpa Soelaeman

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Malnourishment
Nutritional, Metabolic, Endocrine
Malnourishment

Intervention(s)

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, namely 34 people in the intervention group and 34 control groups. Randomisation is done by block technique 4 (four). Interventions are double-blinded with biscuit packaging, both fortified and placebo, made in the same form and packaging, differing only in content. In the intervention group, participants receive fortified biscuits as much as two pieces per day as a dietary supplement. Those in the control group receive a placebo biscuit as much as two pieces per day as a dietary supplement.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

17-06-0605

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Research Ethics Committee of the Faculty of Medicine University of Indonesia and Cipto Mangunkusumo Hospital Jakarta, 19/06/2017, ref: 568 / UN2.F1 / ETIK / 2017 and protocol number: 17-06-0605

Results

• Results available: Yes
• Date Completed: 31/12/2018