Celiac DiseaseGLUTLEARNNCT05923346
Educational Intervention on Celiac Disease and Gluten-free Diet Through Social Networks (GLUTLEARN Project).
A study testing GLUTLEARN in people with Celiac Disease, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial summary
Celiac disease (CD) is an autoimmune disease that occurs in people who are genetically predisposed to gluten consumption (1). The prevalence of the disease is about 1-2% and it is more common in women than in men, and in children than in adults (2). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- GLUTLEARN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be of legal age
- Have celiac disease or be involved in the care of a person with celiac disease
- Be an Instagram user
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of the Basque Country (UPV/EHU)
Vitoria-Gasteiz, Álava, 01006
About this study
Celiac disease (CD) is an autoimmune disease that occurs in people who are genetically predisposed to gluten consumption (1). The prevalence of the disease is about 1-2% and it is more common in women than in men, and in children than in adults (2).
The only current treatment for celiac disease is a strict, lifelong gluten-free diet. This involves the complete elimination of gluten from the diet. Gluten is not only present in some cereals such as wheat, rye, barley and oats, but is also found in many foods that have been processed. In addition to being safe, the gluten-free diet must also be balanced.
Read more
Following a gluten-free diet creates psychological and social problems for the people who have to follow it (3). It has been seen in several studies that people with celiac condition can feel different and excluded, as it is difficult to eat out, to make sure that the food is gluten-free and to avoid cross-contact (4-8).
Due to the complicate situation of people with celiac disease, they do not hesitate to seek information about the management of their diseas. That is why people with celiac disease turn to social networks, as a rapid, visual and accessible way to share information (9-11).
In line with the objectives of the University to which the Gluten3S research group belongs to (University of the Basque Country, UPV/EHU), the group has been aware for some time of the importance of disseminating science on social networks in order to make the results of the research reach the general public. It is considered that creating a nutritional education programme about CD and Gluten-Free Diet (GFD), delivered by experts in the field, could be useful in improving knowledge and attitudes about this matter. This will empower people with CD to improve their self-care and take control of their situation. Furthermore, it is also interesting to design the programme in such a way that the impact of the intervention can be measured, always with the intention of continuous improvement and reaching people with celiac disease and their environment in an effective way.
The educational intervention will be carried out for one month and is aimed at adults with coeliac disease or adults with coeliac relatives who are involved in their care. Each day a post will be uploaded to Instagram with specific, accurate and current information. The content of the intervention has been divided into 5 main blocks: 1) general concepts about CD, 2) balanced GFD, 3) food labelling, 4) cross-contact/cross-contamination, 5) new research on CD and useful resources for disease management.
The evaluation of the intervention will be carried out through pre- and post-intervention questionnaires.
- Conditions
- Celiac Disease
- Being tested
- GLUTLEARN
- Keywords
- celiac disease, nutrition education, gluten-free diet, balanced diet, social networks
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLUTLEARNOther
The group will be made up of users of the social network Instagram who have celiac disease or are close to a celiac patient (parent/guardian of celiac children or cohabitants).
The intervention will be carried out through the social network Instagram. Participants will be recruited through the same social network. Participants must agree to take part in the study.
The educational intervention will be carried out for one month, where each day a "post" will be uploaded with specific, truthful and current information. The content of the intervention has been divided into 5 main blocks: 1) general concepts about CD, 2) balanced GFD, 3) food labelling, 4) cross-contact/cross-contamination, 5) new research on CD and useful resources for disease management.
| Study group | Role | What they receive |
|---|---|---|
| Glutlearn | Experimental | Not described Receives: Other: GLUTLEARN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge regarding celiac disease
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Measured: 5 weeks
Attitude towards celiac disease: degree of concern
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Measured: 5 weeks
Knowledge regarding balanced GFD
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Measured: 5 weeks
Knowledge regarding food labels
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Measured: 5 weeks
Attitude: degree of confidence in their choice of food
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Measured: 5 weeks
Knowledge regarding cross-contact
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Measured: 5 weeks
Attitude: degree of confidence in avoiding cross-contact
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Measured: 5 weeks
Knowledge regarding new research in CD
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Measured: 5 weeks
Secondary outcomes (2)
Satisfaction about the education received
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test). Secondary outcomes will be measured in the post-questionnaire. • The unit of measure will be the score obtained in the questionnaires (0, disagree-4,agree).
Measured: Immediately after the intervention
Perception of the importance of educational activities
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test). Secondary outcomes will be measured in the post-questionnaire. • The unit of measure will be the score obtained in the questionnaires (0, disagree-4,agree).
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Feb 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Itziar Churruca Ortega, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923346
- Sponsor's protocol ID
- M10_2020_081 GLUTLEARN
- Other IDs
- GIU18/78, GIU21/053, IT-1419-19, University-Society US22/22
- Acronym
- GLUTLEARN
- Status last verified
- Nov 2023
- First submitted
- 19 Jun 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lebwohl B, Rubio-Tapia A. Epidemiology, Presentation, and Diagnosis of Celiac Disease. Gastroenterology. 2021 Jan;160(1):63-75. doi: 10.1053/j.gastro.2020.06.098. Epub 2020 Sep 18.
PubMed 32950520Singh P, Arora A, Strand TA, Leffler DA, Catassi C, Green PH, Kelly CP, Ahuja V, Makharia GK. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Jun;16(6):823-836.e2. doi: 10.1016/j.cgh.2017.06.037. Epub 2018 Mar 16.
PubMed 29551598Itzlinger A, Branchi F, Elli L, Schumann M. Gluten-Free Diet in Celiac Disease-Forever and for All? Nutrients. 2018 Nov 18;10(11):1796. doi: 10.3390/nu10111796.
PubMed 30453686Rosen A, Ivarsson A, Nordyke K, Karlsson E, Carlsson A, Danielsson L, Hogberg L, Emmelin M. Balancing health benefits and social sacrifices: a qualitative study of how screening-detected celiac disease impacts adolescents' quality of life. BMC Pediatr. 2011 May 10;11:32. doi: 10.1186/1471-2431-11-32.
PubMed 21569235Olsson C, Lyon P, Hornell A, Ivarsson A, Sydner YM. Food that makes you different: the stigma experienced by adolescents with celiac disease. Qual Health Res. 2009 Jul;19(7):976-84. doi: 10.1177/1049732309338722.
PubMed 19556403Cadenhead JW, Wolf RL, Lebwohl B, Lee AR, Zybert P, Reilly NR, Schebendach J, Satherley R, Green PHR. Diminished quality of life among adolescents with coeliac disease using maladaptive eating behaviours to manage a gluten-free diet: a cross-sectional, mixed-methods study. J Hum Nutr Diet. 2019 Jun;32(3):311-320. doi: 10.1111/jhn.12638. Epub 2019 Mar 5.
PubMed 30834587Wolf RL, Lebwohl B, Lee AR, Zybert P, Reilly NR, Cadenhead J, Amengual C, Green PHR. Hypervigilance to a Gluten-Free Diet and Decreased Quality of Life in Teenagers and Adults with Celiac Disease. Dig Dis Sci. 2018 Jun;63(6):1438-1448. doi: 10.1007/s10620-018-4936-4. Epub 2018 Jan 31.
PubMed 29387990Singh P, Dennis M. Eliminating Dietary Gluten: Don't Be a "Glutton for Punishment". Dig Dis Sci. 2018 Jun;63(6):1374-1375. doi: 10.1007/s10620-018-5010-y. No abstract available.
PubMed 29546643Al Sarkhy A. Social media usage pattern and its influencing factors among celiac patients and their families. Saudi J Gastroenterol. 2020 Mar-Apr;26(2):99-104. doi: 10.4103/sjg.SJG_495_19.
PubMed 32031161McNally SL, Donohue MC, Newton KP, Ogletree SP, Conner KK, Ingegneri SE, Kagnoff MF. Can consumers trust web-based information about celiac disease? Accuracy, comprehensiveness, transparency, and readability of information on the internet. Interact J Med Res. 2012 Apr 4;1(1):e1. doi: 10.2196/ijmr.2010.
PubMed 23611901Trovato CM, Montuori M, Oliva S, Cucchiara S, Cignarelli A, Sansone A. Assessment of public perceptions and concerns of celiac disease: A Twitter-based sentiment analysis study. Dig Liver Dis. 2020 Apr;52(4):464-466. doi: 10.1016/j.dld.2020.02.004. Epub 2020 Feb 29. No abstract available.
PubMed 32127326Vazquez-Polo M, Navarro V, Larretxi I, Perez-Junkera G, Lasa A, Matias S, Simon E, Churruca I. Uncovering the Concerns and Needs of Individuals with Celiac Disease: A Cross-Sectional Study. Nutrients. 2023 Aug 22;15(17):3681. doi: 10.3390/nu15173681.
PubMed 37686713
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention on Celiac Disease and Gluten-free Diet Through Social Networks (GLUTLEARN Project).
- ClinicalTrials.gov ID
- NCT05923346
- Acronym / sponsor ID
- GLUTLEARN / M10_2020_081 GLUTLEARN
- Conditions
- Celiac Disease
- Keywords
- celiac disease, nutrition education, gluten-free diet, balanced diet, social networks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Celiac disease (CD) is an autoimmune disease that occurs in people who are genetically predisposed to gluten consumption (1). The prevalence of the disease is about 1-2% and it is more common in women than in men, and in children than in adults (2).
The only current treatment for celiac disease is a strict, lifelong gluten-free diet. This involves the complete elimination of gluten from the diet. Gluten is not only present in some cereals such as wheat, rye, barley and oats, but is also found in many foods that have been processed. In addition to being safe, the gluten-free diet must also be balanced.
Following a gluten-free diet creates psychological and social problems for the people who have to follow it (3). It has been seen in several studies that people with celiac condition can feel different and excluded, as it is difficult to eat out, to make sure that the food is gluten-free and to avoid cross-contact (4-8).
Due to the complicate situation of people with celiac disease, they do not hesitate to seek information about the management of their diseas. That is why people with celiac disease turn to social networks, as a rapid, visual and accessible way to share information (9-11).
In line with the objectives of the University to which the Gluten3S research group belongs to (University of the Basque Country, UPV/EHU), the group has been aware for some time of the importance of disseminating science on social networks in order to make the results of the research reach the general public. It is considered that creating a nutritional education programme about CD and Gluten-Free Diet (GFD), delivered by experts in the field, could be useful in improving knowledge and attitudes about this matter. This will empower people with CD to improve their self-care and take control of their situation. Furthermore, it is also interesting to design the programme in such a way that the impact of the intervention can be measured, always with the intention of continuous improvement and reaching people with celiac disease and their environment in an effective way.
The educational intervention will be carried out for one month and is aimed at adults with coeliac disease or adults with coeliac relatives who are involved in their care. Each day a post will be uploaded to Instagram with specific, accurate and current information. The content of the intervention has been divided into 5 main blocks: 1) general concepts about CD, 2) balanced GFD, 3) food labelling, 4) cross-contact/cross-contamination, 5) new research on CD and useful resources for disease management.
The evaluation of the intervention will be carried out through pre- and post-intervention questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glutlearn | Experimental | Other: GLUTLEARN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be of legal age
- Have celiac disease or be involved in the care of a person with celiac disease
- Be an Instagram user
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLUTLEARNThe group will be made up of users of the social network Instagram who have celiac disease or are close to a celiac patient (parent/guardian of celiac children or cohabitants). The intervention will be carried out through the social network Instagram. Participants will be recruited through the same social network. Participants must agree to take part in the study. The educational intervention will be carried out for one month, where each day a "post" will be uploaded with specific, truthful and current information. The content of the intervention has been divided into 5 main blocks: 1) general concepts about CD, 2) balanced GFD, 3) food labelling, 4) cross-contact/cross-contamination, 5) new research on CD and useful resources for disease management. | Other | Glutlearn |
Primary outcome
Knowledge regarding celiac disease
Time frame: 5 weeks
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Attitude towards celiac disease: degree of concern
Time frame: 5 weeks
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Knowledge regarding balanced GFD
Time frame: 5 weeks
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Knowledge regarding food labels
Time frame: 5 weeks
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Attitude: degree of confidence in their choice of food
Time frame: 5 weeks
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Knowledge regarding cross-contact
Time frame: 5 weeks
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Attitude: degree of confidence in avoiding cross-contact
Time frame: 5 weeks
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
Knowledge regarding new research in CD
Time frame: 5 weeks
A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers).
2 secondary outcomes
Satisfaction about the education received
Time frame: Immediately after the intervention
Perception of the importance of educational activities
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 32950520Lebwohl B, Rubio-Tapia A. Epidemiology, Presentation, and Diagnosis of Celiac Disease. Gastroenterology. 2021 Jan;160(1):63-75. doi: 10.1053/j.gastro.2020.06.098. Epub 2020 Sep 18.
- Background: PubMed 29551598Singh P, Arora A, Strand TA, Leffler DA, Catassi C, Green PH, Kelly CP, Ahuja V, Makharia GK. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Jun;16(6):823-836.e2. doi: 10.1016/j.cgh.2017.06.037. Epub 2018 Mar 16.
- Background: PubMed 30453686Itzlinger A, Branchi F, Elli L, Schumann M. Gluten-Free Diet in Celiac Disease-Forever and for All? Nutrients. 2018 Nov 18;10(11):1796. doi: 10.3390/nu10111796.
- Background: PubMed 21569235Rosen A, Ivarsson A, Nordyke K, Karlsson E, Carlsson A, Danielsson L, Hogberg L, Emmelin M. Balancing health benefits and social sacrifices: a qualitative study of how screening-detected celiac disease impacts adolescents' quality of life. BMC Pediatr. 2011 May 10;11:32. doi: 10.1186/1471-2431-11-32.
- Background: PubMed 19556403Olsson C, Lyon P, Hornell A, Ivarsson A, Sydner YM. Food that makes you different: the stigma experienced by adolescents with celiac disease. Qual Health Res. 2009 Jul;19(7):976-84. doi: 10.1177/1049732309338722.
- Background: PubMed 30834587Cadenhead JW, Wolf RL, Lebwohl B, Lee AR, Zybert P, Reilly NR, Schebendach J, Satherley R, Green PHR. Diminished quality of life among adolescents with coeliac disease using maladaptive eating behaviours to manage a gluten-free diet: a cross-sectional, mixed-methods study. J Hum Nutr Diet. 2019 Jun;32(3):311-320. doi: 10.1111/jhn.12638. Epub 2019 Mar 5.
- Background: PubMed 29387990Wolf RL, Lebwohl B, Lee AR, Zybert P, Reilly NR, Cadenhead J, Amengual C, Green PHR. Hypervigilance to a Gluten-Free Diet and Decreased Quality of Life in Teenagers and Adults with Celiac Disease. Dig Dis Sci. 2018 Jun;63(6):1438-1448. doi: 10.1007/s10620-018-4936-4. Epub 2018 Jan 31.
- Background: PubMed 29546643Singh P, Dennis M. Eliminating Dietary Gluten: Don't Be a "Glutton for Punishment". Dig Dis Sci. 2018 Jun;63(6):1374-1375. doi: 10.1007/s10620-018-5010-y. No abstract available.
- Background: PubMed 32031161Al Sarkhy A. Social media usage pattern and its influencing factors among celiac patients and their families. Saudi J Gastroenterol. 2020 Mar-Apr;26(2):99-104. doi: 10.4103/sjg.SJG_495_19.
- Background: PubMed 23611901McNally SL, Donohue MC, Newton KP, Ogletree SP, Conner KK, Ingegneri SE, Kagnoff MF. Can consumers trust web-based information about celiac disease? Accuracy, comprehensiveness, transparency, and readability of information on the internet. Interact J Med Res. 2012 Apr 4;1(1):e1. doi: 10.2196/ijmr.2010.
- Background: PubMed 32127326Trovato CM, Montuori M, Oliva S, Cucchiara S, Cignarelli A, Sansone A. Assessment of public perceptions and concerns of celiac disease: A Twitter-based sentiment analysis study. Dig Liver Dis. 2020 Apr;52(4):464-466. doi: 10.1016/j.dld.2020.02.004. Epub 2020 Feb 29. No abstract available.
- Results publication: PubMed 37686713Vazquez-Polo M, Navarro V, Larretxi I, Perez-Junkera G, Lasa A, Matias S, Simon E, Churruca I. Uncovering the Concerns and Needs of Individuals with Celiac Disease: A Cross-Sectional Study. Nutrients. 2023 Aug 22;15(17):3681. doi: 10.3390/nu15173681.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLUTLEARN in people with Celiac Disease, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge regarding celiac disease (time frame: 5 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05923346, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.