Celiac DiseaseNCT03168490
In Vivo Effects of the Gluten Friendly Bread in Coeliac Disease
A study testing Gluten Friendly bread in people with Celiac Disease, run by University of Roehampton at 1 site in United Kingdom.
Trial summary
In the last two decades, a series of epidemiological studies have shown a particular increase in Coeliac Disease (CD), a life-long intolerance to gluten proteins (the seed storage proteins) present in most cereals (wheat, barley and rye) both in the United States and Europe, and in developing countries. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Gluten Friendly bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2016to 28 Sep 2021
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 20-80 years of age
- Have a medical diagnosis for coeliac disease (blood test and biopsy confirmed)
- On a gluten-free diet for a minimum of 12 months
- Able to attend 6 appointments and donate blood, urine and faecal samples before and after bread intake
- Willing to participate in the entire study (signed informed consent required)
Who cannot join
- History or evidence of intestinal disease; such as tumour, irritable bowel syndrome, etc., within the previous 5 years
- Diagnosed with another auto-immune condition (e.g. Type 1 diabetes, autoimmune thyroid disease)
- Be extremely sensitive to exposure to gluten
- Received antibiotics in the previous six months
- History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma)
- Smoker
Show all 25Show fewer
- Lactose intolerant
- Currently prescribed immunosuppressive drugs. Participants will be required to withdraw should they begin taking any of the ineligible medication
- Intention to use regularly other medication which affects gastrointestinal motility
- History of alcohol or drug misuse
- Suffer from any major conditions involving the following:
- Head
- Ears
- Eyes
- Nose and Throat
- Dermatological/Connective tissue
- Neurological
- Lymphatic
- Urogenital/Rectal
- Abdominal
- Respiratory
- A previous cardiovascular event within the last 6 months
- presence of secondary dyslipemias related to thyroid dysfunction
- used any drug affecting lipid metabolism in previous 3 months
- a history of alcohol abuse
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, SW15 4JD
About this study
Official title: In Vivo Human Intervention Approach to Test the Effects of "Gluten Friendly Bread" in Coeliac Disease Patients: GLUTEN FRIENDLY STUDY
In the last two decades, a series of epidemiological studies have shown a particular increase in Coeliac Disease (CD), a life-long intolerance to gluten proteins (the seed storage proteins) present in most cereals (wheat, barley and rye) both in the United States and Europe, and in developing countries. In these subjects, the consumption of cereals containing gluten causes a chronic inflammatory process leading to lesions in the small intestine and a dysfunction in nutrient absorption.The only current treatment for CD is a strict lifelong gluten-free diet. In most cases (some people do not respond) this dietary regimen guarantees the full recovery of small intestine architecture and functions, though for many patients the gluten-free diet is highly restrictive, especially for social events and during travelling. In addition, this dietary therapy has often low content of vitamins and ions, such as vitamins B and calcium, iron, zinc and magnesium, as well as fibre. Furthermore, one of the major risks is to develop obesity and diseases related to metabolic syndrome.
Recently a new and innovative detoxification method has been developed with the purpose to overcome the disadvantages of the prior methods. The method is based on the application of microwave energy for few seconds to hydrated wheat kernels; the treatment induces modifications to endosperm components which dramatically reduce the immunogenicity of the most common epitopes involved in coeliac disease, without compromising the technological properties necessary to process flour into bread, pasta and other baked goods.
The method is based on the analysis of recent studies that have reported, when high temperatures are applied to the caryopsis of wheat, the protein polymers present in the pasta produced with these "baked grain" present a size distribution pattern that is not observed in pasta during the drying cycles. The researchers Lamacchia and others explained this phenomenon on the basis of the fact that in the caryopsis of wheat, gluten is not yet formed and gluten proteins are deposited in different protein bodies.
Read the detailed description
The aim of this study is to investigate the effects of gluten friendly bread on the faecal microbiota composition, metabolism and immunity in coeliac individuals aged 20-80 years.
The study consists of a 6-visit (screening visit + 5 visits) randomised intervention with the Gluten Friendly bread at different doses and placebo (control bread).
Subjects will be randomly distributed into four groups: placebo (control bread in a dose of 1.5 g gluten/day), low gluten group taking the Gluten Friendly bread in a dose of 1.5 g gluten/day, medium gluten group (3 g gluten/day) and high gluten group (6 g gluten/day). As wheat generally contains 10% of gluten (i.e. 100 g of bread contain 10 g of gluten), bread buns of 60 g, 30 g and 15 g will be elaborated for high, medium and low gluten groups, respectively.
Control bread and also gluten free bread as 15g buns will be assessed as controls.
The study will include a screening visit, baseline visit, visits at midpoint, endpoint of the treatment periods and a final visit after 2 weeks of the treatment. Volunteers will provide a blood sample at a pre- screening visit (~10ml; 1 dessert spoon), to check for anaemia (defined as haemoglobin men <14g/dl; women <11.5g/dl). The design will include a 14-day run-in period followed by 14 days of treatment and a final visit post-gluten challenge. Participants will be asked to consume a multi-sugar drink (7.5g lactulose and 2g D-mannitol ≥98% in 100 ml of water) (a dosage used widely in oral clinical testing- LAMA testing) in the evening before each study visit (visits: 1, 2, 3, 4 and 5) at 8 pm and be instructed to collect all overnight and morning first spot pass urine sample. This non-invasive assessment of intestinal permeability in humans has a 20-year history. LAMA evaluation has been reported to be an accurate measure of small intestinal mucosal permeability though assessment of differential absorption of lactulose and mannitol. They will also provide a faecal sample for each study visit (visits: 1, 2, 3, 4 and 5).
Each visit will take approximately 30 minutes.
- Conditions
- Celiac Disease
- Being tested
- Gluten Friendly bread
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten Friendly breadDietary supplement
parallel study
| Study group | Role | What they receive |
|---|---|---|
| 1.5g low gluten friendly bread | Active comparator | 1.5g low gluten friendly bread as15g bun/day to be consumed as 250 ml beverages at breakfast for 14 days Receives: Dietary Supplement: Gluten Friendly bread |
| 3g medium gluten friendly bread | Active comparator | 3g medium gluten friendly bread as 30g bun to be consumed as 250 ml beverages at breakfast for 14days Receives: Dietary Supplement: Gluten Friendly bread |
| 6g high gluten friendly bread | Active comparator | 6g high gluten friendly bread as 60g bun to be consumed as 250 ml beverages at breakfast for 14 days Receives: Dietary Supplement: Gluten Friendly bread |
| Control bread | Placebo comparator | Placebo control bread as 15g bun to be consumed as 250 ml beverages at breakfast for 14 days Receives: Dietary Supplement: Gluten Friendly bread |
| Gluten free bread | Placebo comparator | Gluten bread as 15g bun to be consumed as 250 ml beverages at breakfast for 14 days Receives: Dietary Supplement: Gluten Friendly bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cellular and molecular basis for modulation of immune function by GLUTEN FRIENDLY BREAD
Blood samples will be processed and analyzed for inflammatory/immune biomarkers (trans-glutaminase IgA and IgG, cytokines INF-Ɣ, IL-6, IL-8, IL-10, TNF-α and C-reactive protein).
activation markers, expression of toll like receptors.
Measured: Change from baseline at 14 days
Secondary outcomes (1)
The modulation of the gut microbiota by gluten friendly bread
Fecal16S rRNA amplicon sequencing to assess changes in fecal bacterial abundance and species diversity
Measured: Change from baseline at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Feb 2016
- Primary completion2 Nov 2018
- Study completion28 Sep 2021
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-centre, prospective, randomised, placebo-controlled, parallel-group trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- Carmen Lamacchia, Study director, The University of Foggia-Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168490
- Sponsor's protocol ID
- LSC 15/146
- Status last verified
- Sep 2021
- First submitted
- 22 May 2017
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Human Intervention Approach to Test the Effects of "Gluten Friendly Bread" in Coeliac Disease Patients: GLUTEN FRIENDLY STUDY
- ClinicalTrials.gov ID
- NCT03168490
- Acronym / sponsor ID
- LSC 15/146
- Conditions
- Celiac Disease
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 30 May 2017 (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.
In the last two decades, a series of epidemiological studies have shown a particular increase in Coeliac Disease (CD), a life-long intolerance to gluten proteins (the seed storage proteins) present in most cereals (wheat, barley and rye) both in the United States and Europe, and in developing countries. In these subjects, the consumption of cereals containing gluten causes a chronic inflammatory process leading to lesions in the small intestine and a dysfunction in nutrient absorption.The only current treatment for CD is a strict lifelong gluten-free diet. In most cases (some people do not respond) this dietary regimen guarantees the full recovery of small intestine architecture and functions, though for many patients the gluten-free diet is highly restrictive, especially for social events and during travelling. In addition, this dietary therapy has often low content of vitamins and ions, such as vitamins B and calcium, iron, zinc and magnesium, as well as fibre. Furthermore, one of the major risks is to develop obesity and diseases related to metabolic syndrome.
Recently a new and innovative detoxification method has been developed with the purpose to overcome the disadvantages of the prior methods. The method is based on the application of microwave energy for few seconds to hydrated wheat kernels; the treatment induces modifications to endosperm components which dramatically reduce the immunogenicity of the most common epitopes involved in coeliac disease, without compromising the technological properties necessary to process flour into bread, pasta and other baked goods.
The method is based on the analysis of recent studies that have reported, when high temperatures are applied to the caryopsis of wheat, the protein polymers present in the pasta produced with these "baked grain" present a size distribution pattern that is not observed in pasta during the drying cycles. The researchers Lamacchia and others explained this phenomenon on the basis of the fact that in the caryopsis of wheat, gluten is not yet formed and gluten proteins are deposited in different protein bodies.
Detailed description
The aim of this study is to investigate the effects of gluten friendly bread on the faecal microbiota composition, metabolism and immunity in coeliac individuals aged 20-80 years.
The study consists of a 6-visit (screening visit + 5 visits) randomised intervention with the Gluten Friendly bread at different doses and placebo (control bread).
Subjects will be randomly distributed into four groups: placebo (control bread in a dose of 1.5 g gluten/day), low gluten group taking the Gluten Friendly bread in a dose of 1.5 g gluten/day, medium gluten group (3 g gluten/day) and high gluten group (6 g gluten/day). As wheat generally contains 10% of gluten (i.e. 100 g of bread contain 10 g of gluten), bread buns of 60 g, 30 g and 15 g will be elaborated for high, medium and low gluten groups, respectively.
Control bread and also gluten free bread as 15g buns will be assessed as controls.
The study will include a screening visit, baseline visit, visits at midpoint, endpoint of the treatment periods and a final visit after 2 weeks of the treatment. Volunteers will provide a blood sample at a pre- screening visit (~10ml; 1 dessert spoon), to check for anaemia (defined as haemoglobin men <14g/dl; women <11.5g/dl). The design will include a 14-day run-in period followed by 14 days of treatment and a final visit post-gluten challenge. Participants will be asked to consume a multi-sugar drink (7.5g lactulose and 2g D-mannitol ≥98% in 100 ml of water) (a dosage used widely in oral clinical testing- LAMA testing) in the evening before each study visit (visits: 1, 2, 3, 4 and 5) at 8 pm and be instructed to collect all overnight and morning first spot pass urine sample. This non-invasive assessment of intestinal permeability in humans has a 20-year history. LAMA evaluation has been reported to be an accurate measure of small intestinal mucosal permeability though assessment of differential absorption of lactulose and mannitol. They will also provide a faecal sample for each study visit (visits: 1, 2, 3, 4 and 5).
Each visit will take approximately 30 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- A single-centre, prospective, randomised, placebo-controlled, parallel-group trial
| Arm | Type | Receives |
|---|---|---|
| 1.5g low gluten friendly bread | Active comparator | Dietary Supplement: Gluten Friendly bread1.5g low gluten friendly bread as15g bun/day to be consumed as 250 ml beverages at breakfast for 14 days |
| 3g medium gluten friendly bread | Active comparator | Dietary Supplement: Gluten Friendly bread3g medium gluten friendly bread as 30g bun to be consumed as 250 ml beverages at breakfast for 14days |
| 6g high gluten friendly bread | Active comparator | Dietary Supplement: Gluten Friendly bread6g high gluten friendly bread as 60g bun to be consumed as 250 ml beverages at breakfast for 14 days |
| Control bread | Placebo comparator | Dietary Supplement: Gluten Friendly breadPlacebo control bread as 15g bun to be consumed as 250 ml beverages at breakfast for 14 days |
| Gluten free bread | Placebo comparator | Dietary Supplement: Gluten Friendly breadGluten bread as 15g bun to be consumed as 250 ml beverages at breakfast for 14 days |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 20-80 years of age
- Have a medical diagnosis for coeliac disease (blood test and biopsy confirmed)
- On a gluten-free diet for a minimum of 12 months
- Able to attend 6 appointments and donate blood, urine and faecal samples before and after bread intake
- Willing to participate in the entire study (signed informed consent required)
Key exclusion criteria (25 listed)
- History or evidence of intestinal disease; such as tumour, irritable bowel syndrome, etc., within the previous 5 years
- Diagnosed with another auto-immune condition (e.g. Type 1 diabetes, autoimmune thyroid disease)
- Be extremely sensitive to exposure to gluten
- Received antibiotics in the previous six months
- History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma)
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 |
|---|---|---|
| Gluten Friendly breadparallel study | Dietary supplement | 1.5g low gluten friendly bread, 3g medium gluten friendly bread, 6g high gluten friendly bread, Control bread, Gluten free bread |
Primary outcome
The cellular and molecular basis for modulation of immune function by GLUTEN FRIENDLY BREAD
Time frame: Change from baseline at 14 days
Blood samples will be processed and analyzed for inflammatory/immune biomarkers (trans-glutaminase IgA and IgG, cytokines INF-Ɣ, IL-6, IL-8, IL-10, TNF-α and C-reactive protein). activation markers, expression of toll like receptors.
1 secondary outcome
The modulation of the gut microbiota by gluten friendly bread
Time frame: Change from baseline at 14 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- 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.
Carmen Lamacchia study director
The University of Foggia-Italy
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 Friendly bread in people with Celiac Disease, run by University of Roehampton at 1 site in United Kingdom.
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 5 inclusion and 25 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: stopped early, as of the sponsor's last update on 29 Sep 2021. 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 United Kingdom. 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?
The study was stopped early. Results are not available in the source record.
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?
The cellular and molecular basis for modulation of immune function by GLUTEN FRIENDLY BREAD (time frame: Change from baseline at 14 days). 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 29 Sep 2021.