Celiac DiseaseCELLiomicSNCT07362654
Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease
A study testing Gluten 50 mg, Gluten 5 g and Collection of blood, stool and urine samples on Day 1 and Day 8. in people with Celiac Disease and Gluten Sensitivity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
This study investigates how the immune system of children with celiac disease responds to controlled, small amounts of gluten. Children on a strict gluten-free diet are randomly assigned to receive either placebo, 50 mg of gluten, or 5 g of gluten once daily for three days, simulating real-life accidental exposure or… Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Celiac Disease, Gluten Sensitivity, Autoimmune Diseases
- What is being tested?
- Gluten 50 mg, Gluten 5 g and Collection of blood, stool and urine samples on Day 1 and Day 8.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jul 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8 to 14 years at study entry.
- Diagnosis of celiac disease according to ESPGHAN 2020 criteria.
- At least 18 months on a strict gluten-free diet (GFD).
- Adequate adherence to the GFD, demonstrated by negative fecal gluten immunogenic peptides (GIP) prior to inclusion.
- Asymptomatic from a gastrointestinal perspective in the preceding weeks.
- Ability to swallow the gluten/placebo preparation.
- Written informed consent from parents/legal guardians and assent from the child.
Who cannot join
- Obesity defined as BMI ≥ 95th percentile according to WHO criteria.
- Diagnosed inflammatory bowel disease or diabetes mellitus.
- Acute infectious illness at the time of inclusion.
- Chronic hepatic, pulmonary, renal, or rheumatologic disease.
- History of severe acute reactions to accidental gluten ingestion.
- Use of oral corticosteroids or immunosuppressive therapy in the previous 3 months.
- Any condition that, in the opinion of the investigators, may contraindicate participation or compromise study integrity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, 29010
Rafael Martín Masot, MD, PhD, +34 951 290 000, rafammgr@uma.es
Lara María Bossini Castillo, MD, PhD, lbossinicastillo@ugr.es
About this study
Official title: Single-cell Study of the Systemic Immune Response to Controlled Gluten Intake in Pediatric Celiac Disease
This study investigates how the immune system of children with celiac disease responds to controlled, small amounts of gluten. Children on a strict gluten-free diet are randomly assigned to receive either placebo, 50 mg of gluten, or 5 g of gluten once daily for three days, simulating real-life accidental exposure or dietary transgression. Blood samples are collected on Day 1 (before gluten intake) and Day 8 (five days after the last dose). Stool and urine samples are also collected for complementary analyses.
Using single-cell ribonucleic acid (RNA) sequencing, T-cell receptor sequencing, microRNA profiling, and exploratory metabolomics, the study aims to characterize changes in immune cell populations and gene expression after gluten exposure. The objective is to determine whether even very small amounts of gluten induce measurable systemic immune responses and whether these responses differ according to the dose administered. Understanding these mechanisms may support the development of new biomarkers and improve clinical management of pediatric celiac disease.
Read the detailed description
Celiac disease is a chronic, immune-mediated enteropathy triggered by gluten ingestion in genetically predisposed individuals. In pediatric patients, strict adherence to a gluten-free diet (GFD) leads to mucosal recovery and clinical improvement; however, the systemic immunological landscape during long-term GFD remains incompletely understood. Accidental gluten exposure is common in daily life and may trigger subclinical immune activation even in the absence of overt symptoms. The biological consequences of such low-dose exposures, particularly at the single-cell level, are not fully characterized in children.
CELLiomicS (Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease) is a randomized, controlled, parallel-group clinical study designed to characterize systemic immune responses to controlled gluten ingestion in pediatric patients with established celiac disease. Eligible participants are children aged 8-14 years who have followed a strict GFD for at least 18 months before enrollment. The minimum estimated sample size was 45 participants with biopsy- or serology-confirmed celiac disease. Anticipating dropout rate or non-analyzable data of approximately 10-15%, the study planned to recruit a total of 51 participants.
Participants are randomized into three intervention groups: placebo, 50 mg gluten, or 5 g gluten. The selected gluten doses represent two clinically relevant scenarios: (1) accidental low-level exposure (50 mg), and (2) dietary transgression (5 g), both below the threshold typically required to cause serological relapse. Gluten or placebo is administered once daily on Days 1, 2, and 3. Blood samples are obtained on Day 1 (baseline) and Day 8 (five days after the final dose). Stool and urine samples are also collected at the same time points for complementary analyses, including fecal gluten immunogenic peptides (GIP) and exploratory metabolomics.
Peripheral blood mononuclear cells are processed for high-dimensional immune profiling using single-cell RNA sequencing and T-cell receptor (TCR) sequencing (10x Genomics). These analyses enable characterization of immune cell composition, transcriptional activity, and clonal T-cell dynamics before and after gluten challenge. In addition, exosomal microRNA expression is assessed as approved by the ethics committee amendment SICEIA-2025-001434, and untargeted metabolomic profiling of blood, stool, and urine samples is performed to explore systemic metabolic signatures associated with gluten exposure.
The primary objective is to identify gluten-induced transcriptional and cellular changes in peripheral immune cells between baseline (Day 1) and post-intervention (Day 8). Secondary objectives include: (1) assessing dose-dependent immune activation; (2) identifying immune cell subsets and gene expression programs associated with different gluten quantities; (3) characterizing TCR repertoire alterations following gluten exposure; (4) evaluating inter-individual variability in immune responses; (5) analyzing exosomal microRNA changes; and (6) identifying metabolomic signatures associated with gluten ingestion.
By providing a high-resolution view of systemic immune activation following controlled gluten ingestion, this study aims to deepen understanding of the biological impact of real-world gluten exposure in pediatric celiac disease and to support the development of novel biomarkers for dietary monitoring and personalized clinical management.
- Conditions
- Celiac Disease, Gluten Sensitivity, Autoimmune Diseases
- Being tested
- Placebo, Gluten 50 mg, Gluten 5 g, Collection of blood, stool and urine samples on Day 1 and Day 8.
- Keywords
- Celiac Disease, Gluten Exposure, Single-Cell RNA Sequencing, Gluten-Free Diet, Immune Response, Pediatrics, Omics
- Medical subject headings
- Celiac Disease, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo preparation identical in appearance and administration schedule to gluten doses. Administered once daily on Days 1, 2, and 3. Used as the comparator. Participants and evaluators remain blinded to allocation.
Gluten 50 mgDietary supplement
Participants receive 50 mg of gluten once daily on Days 1, 2, and 3. This dose simulates accidental low-level gluten exposure in children with celiac disease. Participants and evaluators remain blinded to allocation.
Gluten 5 gDietary supplement
Participants receive 5 g of gluten once daily on Days 1, 2, and 3. This dose simulates a dietary transgression in children with celiac disease. Participants and evaluators remain blinded to allocation.
Collection of blood, stool and urine samples on Day 1 and Day 8.Procedure or surgery
In addition to blood samples, stool and urine samples will be collected for complementary analyses (including fecal gluten immunogenic peptides (GIP) and exploratory metabolomic assays)
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Participants receive a placebo preparation once daily on Days 1, 2, and 3. Blood samples are collected on Day 1 (baseline) and Day 8 (post-intervention). Participants and evaluators remain blinded to allocation. Receives: Dietary Supplement: Placebo; Procedure: Collection of blood, stool and urine samples on Day 1 and Day 8. |
| Low-Dose Gluten (50 mg) | Experimental | Participants receive 50 mg of gluten once daily on Days 1, 2, and 3, simulating accidental low-level exposure. Blood samples are collected on Day 1 (baseline) and Day 8 (post-intervention). Participants and evaluators remain blinded to allocation. Receives: Dietary Supplement: Gluten 50 mg; Procedure: Collection of blood, stool and urine samples on Day 1 and Day 8. |
| High-Dose Gluten (5 g) | Experimental | Participants receive 5 g of gluten once daily on Days 1, 2, and 3, simulating a dietary transgression. Blood samples are collected on Day 1 (baseline) and Day 8 (post-intervention). Participants and evaluators remain blinded to allocation. Receives: Dietary Supplement: Gluten 5 g; Procedure: Collection of blood, stool and urine samples on Day 1 and Day 8. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peripheral blood immune cell gene expression after controlled gluten ingestion
Change from baseline (Day 1) to post-intervention (Day 8) in gene expression profiles of peripheral blood immune cells measured by single-cell RNA sequencing (scRNA-seq).
Measured: Day 1 to Day 8
Change in peripheral blood T-cell receptor repertoire after controlled gluten ingestion
Change from baseline (Day 1) to post-intervention (Day 8) in T-cell receptor (TCR) diversity and clonality in peripheral blood T cells measured by TCR sequencing
Measured: Day 1 to Day 8
Secondary outcomes (6)
Dose-dependent changes in immune gene expression after gluten exposure
Change from baseline (Day 1) to post-intervention (Day 8) in immune-related gene expression levels measured by single-cell RNA sequencing (scRNA-seq), comparing placebo, 50 mg gluten, and 5 g gluten groups.
Measured: Day 1 to Day 8
Dose-dependent changes in T-cell receptor repertoire clonality after gluten exposure
Change from baseline (Day 1) to post-intervention (Day 8) in T-cell receptor (TCR) clonality and diversity measured by TCR sequencing, comparing placebo, 50 mg gluten, and 5 g gluten groups.
Measured: Day 1 to Day 8
Inter-individual variability in immune gene expression response to gluten exposure across participants
Inter-individual variability in changes from baseline (Day 1) to post-intervention (Day 8) in immune gene expression profiles measured by single-cell RNA sequencing (scRNA-seq).
Measured: Day 1 to Day 8
Changes in serum exosomal microRNA expression after gluten exposure
Change from baseline (Day 1) to post-intervention (Day 8) in serum exosomal microRNA expression levels.
Measured: Day 1 to Day 8
Changes in metabolomic profiles after gluten exposure
Change from baseline (Day 1) to post-intervention (Day 8) in untargeted metabolomic profiles measured in blood, stool, and urine samples.
Measured: Day 1 to Day 8
Changes in peripheral blood immune cell type proportions after gluten exposure
Change from baseline (Day 1) to post-intervention (Day 8) in the relative proportions of immune cell types identified in peripheral blood by single-cell RNA sequencing (scRNA-seq).
Measured: Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start7 Jul 2025
- Primary completionApr 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with celiac disease are randomized into three parallel intervention groups receiving placebo, 50 mg gluten, or 5 g gluten.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Regional de Malaga, Andaluz Health Service, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental, Universidad de Málaga, Consorcio Centro de Investigación Biomédica en Red (CIBER), Biohealth Research Institute in Granada (ibs.GRANADA)
- Responsible party
- Sponsor
- Investigators
- Rafael Martín Masot, MD, PhD, Principal investigator, Hospital Regional Universitario de Málaga / IBIMA-BIONANDLara María Bossini Castillo, MD, PhD, Principal investigator, IBS Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362654
- Sponsor's protocol ID
- PI-0070-2024
- Acronym
- CELLiomicS
- Status last verified
- Nov 2025
- First submitted
- 17 Dec 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset contains highly sensitive genomic, transcriptomic, and immunological data from pediatric participants. Data cannot be sufficiently anonymized to ensure participant privacy under GDPR regulations. Only aggregated results will be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-cell Study of the Systemic Immune Response to Controlled Gluten Intake in Pediatric Celiac Disease
- ClinicalTrials.gov ID
- NCT07362654
- Acronym / sponsor ID
- CELLiomicS / PI-0070-2024
- Conditions
- Celiac Disease, Gluten Sensitivity, Autoimmune Diseases
- Keywords
- Celiac Disease, Gluten Exposure, Single-Cell RNA Sequencing, Gluten-Free Diet, Immune Response, Pediatrics, Omics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Collaborators
- Hospital Regional de Malaga, Andaluz Health Service, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental, Universidad de Málaga, Consorcio Centro de Investigación Biomédica en Red (CIBER), Biohealth Research Institute in Granada (ibs.GRANADA)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 23 Jan 2026 (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.
This study investigates how the immune system of children with celiac disease responds to controlled, small amounts of gluten. Children on a strict gluten-free diet are randomly assigned to receive either placebo, 50 mg of gluten, or 5 g of gluten once daily for three days, simulating real-life accidental exposure or dietary transgression. Blood samples are collected on Day 1 (before gluten intake) and Day 8 (five days after the last dose). Stool and urine samples are also collected for complementary analyses.
Using single-cell ribonucleic acid (RNA) sequencing, T-cell receptor sequencing, microRNA profiling, and exploratory metabolomics, the study aims to characterize changes in immune cell populations and gene expression after gluten exposure. The objective is to determine whether even very small amounts of gluten induce measurable systemic immune responses and whether these responses differ according to the dose administered. Understanding these mechanisms may support the development of new biomarkers and improve clinical management of pediatric celiac disease.
Detailed description
Celiac disease is a chronic, immune-mediated enteropathy triggered by gluten ingestion in genetically predisposed individuals. In pediatric patients, strict adherence to a gluten-free diet (GFD) leads to mucosal recovery and clinical improvement; however, the systemic immunological landscape during long-term GFD remains incompletely understood. Accidental gluten exposure is common in daily life and may trigger subclinical immune activation even in the absence of overt symptoms. The biological consequences of such low-dose exposures, particularly at the single-cell level, are not fully characterized in children.
CELLiomicS (Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease) is a randomized, controlled, parallel-group clinical study designed to characterize systemic immune responses to controlled gluten ingestion in pediatric patients with established celiac disease. Eligible participants are children aged 8-14 years who have followed a strict GFD for at least 18 months before enrollment. The minimum estimated sample size was 45 participants with biopsy- or serology-confirmed celiac disease. Anticipating dropout rate or non-analyzable data of approximately 10-15%, the study planned to recruit a total of 51 participants.
Participants are randomized into three intervention groups: placebo, 50 mg gluten, or 5 g gluten. The selected gluten doses represent two clinically relevant scenarios: (1) accidental low-level exposure (50 mg), and (2) dietary transgression (5 g), both below the threshold typically required to cause serological relapse. Gluten or placebo is administered once daily on Days 1, 2, and 3. Blood samples are obtained on Day 1 (baseline) and Day 8 (five days after the final dose). Stool and urine samples are also collected at the same time points for complementary analyses, including fecal gluten immunogenic peptides (GIP) and exploratory metabolomics.
Peripheral blood mononuclear cells are processed for high-dimensional immune profiling using single-cell RNA sequencing and T-cell receptor (TCR) sequencing (10x Genomics). These analyses enable characterization of immune cell composition, transcriptional activity, and clonal T-cell dynamics before and after gluten challenge. In addition, exosomal microRNA expression is assessed as approved by the ethics committee amendment SICEIA-2025-001434, and untargeted metabolomic profiling of blood, stool, and urine samples is performed to explore systemic metabolic signatures associated with gluten exposure.
The primary objective is to identify gluten-induced transcriptional and cellular changes in peripheral immune cells between baseline (Day 1) and post-intervention (Day 8). Secondary objectives include: (1) assessing dose-dependent immune activation; (2) identifying immune cell subsets and gene expression programs associated with different gluten quantities; (3) characterizing TCR repertoire alterations following gluten exposure; (4) evaluating inter-individual variability in immune responses; (5) analyzing exosomal microRNA changes; and (6) identifying metabolomic signatures associated with gluten ingestion.
By providing a high-resolution view of systemic immune activation following controlled gluten ingestion, this study aims to deepen understanding of the biological impact of real-world gluten exposure in pediatric celiac disease and to support the development of novel biomarkers for dietary monitoring and personalized clinical management.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants with celiac disease are randomized into three parallel intervention groups receiving placebo, 50 mg gluten, or 5 g gluten.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo, Procedure: Collection of blood, stool and urine samples on Day 1 and Day 8.Participants receive a placebo preparation once daily on Days 1, 2, and 3. Blood samples are collected on Day 1 (baseline) and Day 8 (post-intervention). Participants and evaluators remain blinded to allocation. |
| Low-Dose Gluten (50 mg) | Experimental | Dietary Supplement: Gluten 50 mg, Procedure: Collection of blood, stool and urine samples on Day 1 and Day 8.Participants receive 50 mg of gluten once daily on Days 1, 2, and 3, simulating accidental low-level exposure. Blood samples are collected on Day 1 (baseline) and Day 8 (post-intervention). Participants and evaluators remain blinded to allocation. |
| High-Dose Gluten (5 g) | Experimental | Dietary Supplement: Gluten 5 g, Procedure: Collection of blood, stool and urine samples on Day 1 and Day 8.Participants receive 5 g of gluten once daily on Days 1, 2, and 3, simulating a dietary transgression. Blood samples are collected on Day 1 (baseline) and Day 8 (post-intervention). Participants and evaluators remain blinded to allocation. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 8 to 14 years at study entry.
- Diagnosis of celiac disease according to ESPGHAN 2020 criteria.
- At least 18 months on a strict gluten-free diet (GFD).
- Adequate adherence to the GFD, demonstrated by negative fecal gluten immunogenic peptides (GIP) prior to inclusion.
- Asymptomatic from a gastrointestinal perspective in the preceding weeks.
Key exclusion criteria (7 listed)
- Obesity defined as BMI ≥ 95th percentile according to WHO criteria.
- Diagnosed inflammatory bowel disease or diabetes mellitus.
- Acute infectious illness at the time of inclusion.
- Chronic hepatic, pulmonary, renal, or rheumatologic disease.
- History of severe acute reactions to accidental gluten ingestion.
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 |
|---|---|---|
| PlaceboPlacebo preparation identical in appearance and administration schedule to gluten doses. Administered once daily on Days 1, 2, and 3. Used as the comparator. Participants and evaluators remain blinded to allocation. | Dietary supplement | Placebo Group |
| Gluten 50 mgParticipants receive 50 mg of gluten once daily on Days 1, 2, and 3. This dose simulates accidental low-level gluten exposure in children with celiac disease. Participants and evaluators remain blinded to allocation. | Dietary supplement | Low-Dose Gluten (50 mg) |
| Gluten 5 gParticipants receive 5 g of gluten once daily on Days 1, 2, and 3. This dose simulates a dietary transgression in children with celiac disease. Participants and evaluators remain blinded to allocation. | Dietary supplement | High-Dose Gluten (5 g) |
| Collection of blood, stool and urine samples on Day 1 and Day 8.In addition to blood samples, stool and urine samples will be collected for complementary analyses (including fecal gluten immunogenic peptides (GIP) and exploratory metabolomic assays) | Procedure or surgery | High-Dose Gluten (5 g), Low-Dose Gluten (50 mg), Placebo Group |
Primary outcome
Change in peripheral blood immune cell gene expression after controlled gluten ingestion
Time frame: Day 1 to Day 8
Change from baseline (Day 1) to post-intervention (Day 8) in gene expression profiles of peripheral blood immune cells measured by single-cell RNA sequencing (scRNA-seq).
Change in peripheral blood T-cell receptor repertoire after controlled gluten ingestion
Time frame: Day 1 to Day 8
Change from baseline (Day 1) to post-intervention (Day 8) in T-cell receptor (TCR) diversity and clonality in peripheral blood T cells measured by TCR sequencing
6 secondary outcomes
Dose-dependent changes in immune gene expression after gluten exposure
Time frame: Day 1 to Day 8
Dose-dependent changes in T-cell receptor repertoire clonality after gluten exposure
Time frame: Day 1 to Day 8
Inter-individual variability in immune gene expression response to gluten exposure across participants
Time frame: Day 1 to Day 8
Changes in serum exosomal microRNA expression after gluten exposure
Time frame: Day 1 to Day 8
Changes in metabolomic profiles after gluten exposure
Time frame: Day 1 to Day 8
Changes in peripheral blood immune cell type proportions after gluten exposure
Time frame: Day 1 to Day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset contains highly sensitive genomic, transcriptomic, and immunological data from pediatric participants. Data cannot be sufficiently anonymized to ensure participant privacy under GDPR regulations. Only aggregated results will be made publicly available.
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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.
Rafael Martín Masot, MD, PhD principal investigator
Hospital Regional Universitario de Málaga / IBIMA-BIONAND
Lara María Bossini Castillo, MD, PhD principal investigator
IBS Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten 50 mg, Gluten 5 g and Collection of blood, stool and urine samples on Day 1 and Day 8. in people with Celiac Disease and Gluten Sensitivity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael Martín Masot, MD, PhD (+34 951290000, rafammgr@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peripheral blood immune cell gene expression after controlled gluten ingestion (time frame: Day 1 to Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2026.