NCT02312349

Brief Summary

Celiac disease (CD) is a chronic autoimmune disorder in genetically susceptible individuals characterized by inflammation of the small intestine due to gluten intolerance. This protein is found in cereals such as wheat, barley and rye. In Argentina, oats are also considered a toxic grain since are as highly contaminated as the previous three. For this reason, the acronym TACC (Trigo, avena, cebada y centono: wheat, oats, barley and centono) is used for their identification. An effective treatment for celiac disease consists in a gluten-free diet (GFD). For most patients, a gluten-free intake results in a symptomatic and pathological complete remission and decreases the risk of complications. The overall prevalence of CD is around 1% in several Western countries. An Argentinian study shows a 1.167 prevalence of CD in studied patients, being doubled for women than men. Another study in a closed population of the Health Plan of Hospital Italiano de Bs As estimated a prevalence of 0.22 CD diagnosis. In developed countries, for each diagnosed case there is an average of 5-10 cases that have not been diagnosed yet. CD patients and their families should be properly informed about GFD, since there are many factors, voluntary and involuntary, which can affect the treatment. Even though a strict diet is imperative, food handling awareness is equally important in order to prevent cross-contamination and gluten intake hidden in certain products. In recent years, several countries have shown an increasing interest in improving the supply of gluten-free foods in supermarkets, food factories and restaurants. In turn, a British study shows that chefs have less awareness about celiac disease than the overall population. Another Canadian study, which assessed the quality of life of people with CD, revealed that 80% of them avoid eating in restaurants for fear of contamination, causing a decrease in their social life. In Argentina, there are associations that generate lists of marks and gluten-free products allowing safe intake of processed foods, however, it is unknown the food supply suitable for consumption for people with CD as well as the staff's knowledge in gluten-free food preparation in restaurants, pubs, pizzerias and fast food places. U.S. has quality assurance systems that certify good manufacturing practices and GFD handling in restaurants and selling local foods, although its application is not mandatory. In our country, there is no such certification, so food safety on restaurants can not be guaranteed. Eating behaviors are influenced by the reality in which people live, including food availability indoors and outdoors. The current lifestyle leads more and more people to make meals away from home, so that the variety and quality of food sold in restaurants and other stores conditions the consumption. Thus, the availability of "safe" foods in places where people with CD carried some of their meals, help improve adherence to the GFD. The aim of this study is to investigate gluten-free products' supply in elaborated food stores in Buenos Aires City and to discover the level of information possessed by manufacturers in the production of food.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

December 3, 2014

Last Update Submit

August 9, 2019

Conditions

Keywords

Celiac DiseaseGluten free elaborated food

Outcome Measures

Primary Outcomes (1)

  • Gluten Free elaborated food

    Percentage of any available elaborated food free of gluten in its preparation an components for each restaurant evaluated

    At baseline

Secondary Outcomes (2)

  • Knowledge about Celiac Disease

    At baseline

  • Appropriate preparation, delivery and storage of Gluten Free dishes

    At baseline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

It will generate a stratified random sample of 15% of businesses (restaurants, bars, pizzerias and fast food outlets) located in the three selected districts. To be used to sample a sampling frame of the selected districts conducted by the same research group (NCT01388972).

You may qualify if:

  • \- Restaurants, bars, pizzerias and fast food outlets, located in the three selected districts.

You may not qualify if:

  • Refusal by the owner or manager of local participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Related Publications (1)

  • Garipe LY, Bravo B, Fernandez M, Garcia M, Petrosini A, Soriano MM, Perman GP, Giunta DH. Evaluacion de la oferta de alimentos libres de gluten en locales de comida elaborada en la Ciudad Autonoma de Buenos Aires. Acta Gastroenterol Latinoam. 2015 Sep;45(3):190-7. Spanish.

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 9, 2014

Study Start

September 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations