Celiac DiseaseProtalsafeNCT03483805
Effects of a Nutritional Solution to Improve Intestinal Permeability in Celiac Patients
A study testing Protalsafe in people with Celiac Disease, run by Société Guaranteed Gluten Free (GGF) at 1 site in France.
Trial summary
Celiac disease (or gluten intolerance) is recognized as one of the most common chronic diseases: prevalence of 1 in 100 to 1/300 people in Europe and the United States. To date, the treatment consists of a total elimination of any source of gluten from the diet. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Protalsafe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2016to 12 Jan 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- celiac disease diagnosis at least 1 year ago
- diagnosis proven through biopsy report or general practioner letter or health insurance cover
- not following a strict gluten free diet (Pavie score 1-3)
- covered by health insurance
- not in exclusion period from another study
Who cannot join
- pregnant, breastfeeding women or planing pregnancy
- gluten intolerance of non celiac origin or any other dietary intolerance of allergy
- digestive pathology other than celiac disease
- chronic transit problems (diarrhoea or constipation)
- uncontrolled pathology
- diabetes
Show all 14Show fewer
- medical treatment impacting outcome markers (corticosteroids, NSAIDS, immune suppressor drugs, pancreatic enzymes, amphetamines)
- recent or regular intake of prebiotics, probiotics, food supplements including B vitamins, iron or calcium.
- antibiotics in the past month
- excessive alcohol intake
- drug user
- planing to change tobacco use
- any other reason why the investigator feels the subject may not be compliant
- adults under judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Controlled and Parallel Study of the Effect of a New Nutritional Solution to Improve Intestinal Permeability in Celiac Patients
Celiac disease (or gluten intolerance) is recognized as one of the most common chronic diseases: prevalence of 1 in 100 to 1/300 people in Europe and the United States. To date, the treatment consists of a total elimination of any source of gluten from the diet. This eviction generates many daily constraints that would explain that more than 50% of patients do not follow this diet correctly. Hidden sources of gluten in a number of foods also carry the burden of this difficulty in effective exclusion. The objective of the ProtAlSafe study is to develop an innovative nutritional approach in the form of a dietary supplement to improve quality of life of patients. The product is not intended to replace a strict gluten-free diet but to propose a nutritional approach in the form of a dietary supplement to improve quality of life of patients. The expected benefits for people consuming the test product are an overall improvement in quality of life and an improvement in biological markers (intestinal permeability, chronic inflammation, etc.) associated with celiac disease.
- Conditions
- Celiac Disease
- Being tested
- Protalsafe, Placebo
- Keywords
- synbiotic, nutrition, permeability, gluten free diet, quality of life, digestive comfort
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtalsafeDietary supplement
mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water
PlaceboDietary supplement
maize maltodextrin in powder form, to be diluted in water
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Protalsafe product, daily, 12 weeks Receives: Dietary Supplement: Protalsafe |
| Placebo | Placebo comparator | Placebo product, daily, 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactulose/mannitol recovery in 5-hour urine sample
ratio of the two sugars following ingestion
Measured: after 12 weeks of treatment
serum zonulin
circulating concentration
Measured: after 12 weeks of treatment
Secondary outcomes (6)
microbiota profile
taxonomic sequencing
Measured: baseline and after 12 weeks of treatment
digestive health
gastrointestinal symptoms rating scale (GSRS), 13 questions with answers rating from 0 to 3
Measured: baseline and after 12 weeks of treatment
digestive comfort
visual analogic scale on digestive symptoms, 5 questions with 10cm scale rating from no symptoms (left) to worsening
Measured: baseline and after 12 weeks of treatment
quality of life- digestive health
celiac disease quality of life questionnaire (F-CDQ), subset of digestive questions
Measured: baseline and after 12 weeks of treatment
quality of life
celiac disease quality of life questionnaire (F-CDQ)
Measured: baseline and after 12 weeks of treatment
circulating inflammation markers
concentration of cytokines interleukin-6, tumor necrosis factor-alpha and interleukin-10
Measured: baseline and after 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start21 Dec 2016
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Guaranteed Gluten Free (GGF)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Polytechnique UniLaSalle, Institut Pasteur de Lille, Association Française des Intolérants au Gluten (AFDIAG)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483805
- Sponsor's protocol ID
- 2016-A00330-51
- Acronym
- Protalsafe
- Status last verified
- Apr 2018
- First submitted
- 19 Mar 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Controlled and Parallel Study of the Effect of a New Nutritional Solution to Improve Intestinal Permeability in Celiac Patients
- ClinicalTrials.gov ID
- NCT03483805
- Acronym / sponsor ID
- Protalsafe / 2016-A00330-51
- Conditions
- Celiac Disease
- Keywords
- synbiotic, nutrition, permeability, gluten free diet, quality of life, digestive comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Société Guaranteed Gluten Free (GGF)Industry (pharma, biotech, devices)
- Collaborators
- Institut Polytechnique UniLaSalle, Institut Pasteur de Lille, Association Française des Intolérants au Gluten (AFDIAG)
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 30 Mar 2018 (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 (or gluten intolerance) is recognized as one of the most common chronic diseases: prevalence of 1 in 100 to 1/300 people in Europe and the United States. To date, the treatment consists of a total elimination of any source of gluten from the diet. This eviction generates many daily constraints that would explain that more than 50% of patients do not follow this diet correctly. Hidden sources of gluten in a number of foods also carry the burden of this difficulty in effective exclusion. The objective of the ProtAlSafe study is to develop an innovative nutritional approach in the form of a dietary supplement to improve quality of life of patients. The product is not intended to replace a strict gluten-free diet but to propose a nutritional approach in the form of a dietary supplement to improve quality of life of patients. The expected benefits for people consuming the test product are an overall improvement in quality of life and an improvement in biological markers (intestinal permeability, chronic inflammation, etc.) associated with celiac disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: ProtalsafeProtalsafe product, daily, 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo product, daily, 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- celiac disease diagnosis at least 1 year ago
- diagnosis proven through biopsy report or general practioner letter or health insurance cover
- not following a strict gluten free diet (Pavie score 1-3)
- covered by health insurance
- not in exclusion period from another study
Key exclusion criteria (14 listed)
- pregnant, breastfeeding women or planing pregnancy
- gluten intolerance of non celiac origin or any other dietary intolerance of allergy
- digestive pathology other than celiac disease
- chronic transit problems (diarrhoea or constipation)
- uncontrolled pathology
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 |
|---|---|---|
| Protalsafemix of prebiotic, probiotic and plant extract in powder form, to be diluted in water | Dietary supplement | Treatment |
| Placebomaize maltodextrin in powder form, to be diluted in water | Dietary supplement | Placebo |
Primary outcome
Lactulose/mannitol recovery in 5-hour urine sample
Time frame: after 12 weeks of treatment
ratio of the two sugars following ingestion
serum zonulin
Time frame: after 12 weeks of treatment
circulating concentration
6 secondary outcomes
microbiota profile
Time frame: baseline and after 12 weeks of treatment
digestive health
Time frame: baseline and after 12 weeks of treatment
digestive comfort
Time frame: baseline and after 12 weeks of treatment
quality of life- digestive health
Time frame: baseline and after 12 weeks of treatment
quality of life
Time frame: baseline and after 12 weeks of treatment
circulating inflammation markers
Time frame: baseline and after 12 weeks of treatment
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 20 Apr 2018.
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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 Protalsafe in people with Celiac Disease, run by Société Guaranteed Gluten Free (GGF) at 1 site in France.
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 14 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 20 Apr 2018. 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 France. 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 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?
Lactulose/mannitol recovery in 5-hour urine sample (time frame: after 12 weeks of treatment). 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 20 Apr 2018.