Isomil Post Marketing Observational Study | NCT01809951

Studies
Isomil Post Marketing Observational Study

NCT01809951

Sponsor

Melva Louisa

Status

Completed

Last Update Posted

Jun 16, 2017Actual

Enrollment

534Actual

Phase

Not provided

Conditions

Cow's Milk Allergy

Interventions

Not provided

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011Actual

Primary Completion Date

Apr 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jan 25, 2013

First Submission Date that Met QC Criteria

Mar 11, 2013

First Posted Date

Mar 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2017

Last Update Posted Date

Jun 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The use of soy-isolate protein based formula for infants with cow's milk protein intolerance is common in Indonesia, however, there has not been any systematic collection of clinical data to determine the formula's gastrointestinal tolerance, and the parent's perceptions regarding the formula.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

534Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Isomil Advance with LCP		4 spoonful of Isomil Advance with LCP in 240 mL of water, 4 times a day

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parent's acceptance in the feeding of a soy-based infant formula with LCP in infants with symptoms suggestive adverse reactions to cow milk protein		4-week

Secondary Outcomes

Measure	Description	Time Frame
percentage of infants with gastrointestinal adverse events		4-week
percentage of infants with adverse events		4-week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infants of 6 - 12 months of age
full term infants
birth weight more than 2500 grams
infants developed symptoms suggestive adverse reactions to cow's milk protein in the investigator's clinical judgements
subject is prescribed a soy-based infant formula by physician

Exclusion Criteria:

established/suspected hypersensitivity fo soy
presence of adverse reactions to cow's milk caused by coincidental infections or other systemic disease
history of blood group incompatibility, premature delivery, HIV infections, major congenital abnormalities, systemic diseases
presence of severe gastrointestinal disorder
subject is participating in any interventional clinical study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

12 Months

Standard Ages

Child

Study Population

Infants with symptoms suggestive adverse reactions to cow's milk protein

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zakiudin Munasir, MD, PhD	Division of allergy and Immunology, Department of Child Health, Faculty of Medicine, Universitas Indonesia	Principal Investigator
Sumadiono, MD, PhD	RS Sardjito, Jl Kesehatan No 1 Yogyakarta	Study Chair
Anang Endaryanto, MD, PhD	Allergy Immunology Working Unit, East Java Branch of Indonesian Pediatric Society	Study Chair
Dina Muktiarti, MD	Sub Divisi Alergi Imunologi IKA FKUI, Jakarta	Study Chair
Dewi Kumara Wati, MD, PhD	RSUP Sanglah, Jl Kesehatan No 1-10 Denpasar Bali	Study Chair
Budi Setiabudiawan, MD, PhD	RS Hasan Sadikin Jl Pasteur No 38 Bandung	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Divisi Alergi Imunologi FKUI RSCM		Jakarta		10430	Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016269	Milk Hypersensitivity

Ancestor Terms

ID	Term
D005512	Food Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided