NCT03495401

Brief Summary

The purpose of this study is to investigate the effects of double fortification (iron and zinc) in synbiotic milk (L.plantarum Dad13 and fructooligosaccharides) on under 5 years stunted children growth, gut microbiota composition, blood zinc and hemoglobin level, and cognitive level.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

April 28, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

March 4, 2018

Last Update Submit

April 29, 2018

Conditions

Stunting

Outcome Measures

Primary Outcomes (1)

  • Changes in Gut Microbiota Associated to Synbiotic Milk Treatment

    Stools samples will be collected and analyzed before and after the intervention and compared between groups (Lactobacillus, Bifidobacteria, Bacteroides, Prevotella, and Enterobacteria) using qPCR method.

    3 months

Secondary Outcomes (6)

  • Changes in Height per Age Z-score Associated to Synbiotic Milk Treatment

    3 months

  • Changes in Hemoglobin Level Associated to Synbiotic Milk Treatment

    3 months

  • Changes in Calprotectin Level Associated to Synbiotic Milk Treatment

    3 months

  • Changes in Blood Zinc Level Associated to Synbiotic Milk Treatment

    3 months

  • Changes in Cognitive Level Associated to Synbiotic Milk Treatment

    3 months

  • +1 more secondary outcomes

Study Arms (2)

fortified synbiotic milk

EXPERIMENTAL

100 ml fortified (7,47 mg ferrous sulphate and 4,33 mg zinc acetate) synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides

Dietary Supplement: fortified synbiotic milk

non-fortified synbiotic milk

PLACEBO COMPARATOR

100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides

Dietary Supplement: non-fortified synbiotic milk

Interventions

fortified synbiotic milkDIETARY_SUPPLEMENT

100 ml fortified (7,47 mg ferrous sulphate and 4,33 mg zinc acetate) synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides

Also known as: susu synbio (synbio milk) fortified
fortified synbiotic milk
non-fortified synbiotic milkDIETARY_SUPPLEMENT

100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides

Also known as: susu synbio (synbio milk) non-fortified
non-fortified synbiotic milk

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age between 2 year to 5 years
  • height per age z-score under -2 (stunting)
  • parents sign inform consent form

You may not qualify if:

  • have congenital abnormality
  • lactose intolerant
  • use antibiotic for more than 2 weeks
  • consume micronutrient supplement (especially iron and zinc) in the last 3 months
  • diagnose with chronic diseases and infection that interfere metabolism (i.e. tuberculosis, HIV, autoimmune disease, diabetes mellitus type 1)
  • suffer marasmus and/or kwashiorkor
  • not willing to continue the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Gadjah Mada

Sleman, D.I.Yogyakarta, 55281, Indonesia

RECRUITING

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Siti Helmyati, DR.

    Gadjah Mada University

    PRINCIPAL INVESTIGATOR

  • Lily A. Lestari, DR.

    Gadjah Mada University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Siti Helmyati, DR.

CONTACT

+62274547775siti.helmyati@gmail.com

Lily A. Lestari, DR.

CONTACT

+62274547775santi_wap@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention group given fortified synbiotic milk, control group given non-fortified synbiotic milk
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR.

Study Record Dates

First Submitted

March 4, 2018

First Posted

April 12, 2018

Study Start

April 28, 2018

Primary Completion

September 30, 2018

Study Completion

December 31, 2018

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

ID(1)