NCT03223181

Brief Summary

In this study the investigators aimed to evaluate diagnostic accuracy the scoring tool used to determine cow's milk protein allergy, the cow's milk related symptom score, is based on the gastrointestinal, respiratory system and dermatological symptoms being together in young Turkish children.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

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

Study Start

First participant enrolled

June 8, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

May 25, 2017

Last Update Submit

December 17, 2017

Conditions

Cow Milk Allergy

Keywords

Comiss

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the cow's milk related symptom score

    point change in cow's milk related symptom score within the 8 weeks follow-up period will be assess

    8 weeks

Study Arms (1)

COMİSS

Measure of CoMiSS followed by two to four weeks eviction Cow's milk protein diet and second CoMiSS measurement

Eligibility Criteria

Age15 Days - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients of 15 days to 1 year of age at the time of enrolment who have COMİSS score ≥12.

You may qualify if:

  • Reminding CMPA-respiratory system and dermatological symptoms and scoring over 12 in CoMİSS.

You may not qualify if:

  • Infants already fed with extensive hydrolyzed formula or amino aside based on formula.
  • Patients with a disease impairing normal gut transit, a known lactose intolerance severe chronic diarrhea, failure to thrive and neurological disease those that use antibiotics and those that have recently had surgical intervention or medical treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital Ankara University School of Medicine

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Lifschitz C, Szajewska H. Cow's milk allergy: evidence-based diagnosis and management for the practitioner. Eur J Pediatr. 2015 Feb;174(2):141-50. doi: 10.1007/s00431-014-2422-3. Epub 2014 Sep 26.

    PMID: 25257836BACKGROUND

  • Koletzko S, Niggemann B, Arato A, Dias JA, Heuschkel R, Husby S, Mearin ML, Papadopoulou A, Ruemmele FM, Staiano A, Schappi MG, Vandenplas Y; European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Diagnostic approach and management of cow's-milk protein allergy in infants and children: ESPGHAN GI Committee practical guidelines. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):221-9. doi: 10.1097/MPG.0b013e31825c9482.

    PMID: 22569527BACKGROUND

  • Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2.

    PMID: 15893282BACKGROUND

  • Piemontese P, Gianni ML, Braegger CP, Chirico G, Gruber C, Riedler J, Arslanoglu S, van Stuijvenberg M, Boehm G, Jelinek J, Roggero P; MIPS 1 Working Group. Tolerance and safety evaluation in a large cohort of healthy infants fed an innovative prebiotic formula: a randomized controlled trial. PLoS One. 2011;6(11):e28010. doi: 10.1371/journal.pone.0028010. Epub 2011 Nov 30.

    PMID: 22140499BACKGROUND

  • Vandenplas Y, Dupont C, Eigenmann P, Host A, Kuitunen M, Ribes-Koninckx C, Shah N, Shamir R, Staiano A, Szajewska H, Von Berg A. A workshop report on the development of the Cow's Milk-related Symptom Score awareness tool for young children. Acta Paediatr. 2015 Apr;104(4):334-9. doi: 10.1111/apa.12902. Epub 2015 Jan 29.

    PMID: 25557474RESULT

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • CANSU ALTUNTAS, DR

    Ankara University

    PRINCIPAL INVESTIGATOR

  • ZARIFE KULOGLU, PROF

    Ankara University

    PRINCIPAL INVESTIGATOR

  • BETUL ULUKOL, PROF

    Ankara University

    PRINCIPAL INVESTIGATOR

  • SEDA TOPCU, DR

    Ankara University

    PRINCIPAL INVESTIGATOR

  • NISA EDA CULLAS ILARSLAN, DR

    Ankara University

    PRINCIPAL INVESTIGATOR

  • FATIH GUNAY, DR

    Ankara University

    PRINCIPAL INVESTIGATOR

  • NESLİHAN DOĞULU, MD

    Ankara University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SUNA SELBUZ, DR

CONTACT

905070073704kaymaksuna@gmail.com

AYDAN KANSU, PROF

CONTACT

905053591130aydankansu@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant doctor

Study Record Dates

First Submitted

May 25, 2017

First Posted

July 21, 2017

Study Start

June 8, 2015

Primary Completion

December 20, 2017

Study Completion

December 25, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)