Celiac DiseaseNCT03775499
Probiotic BL NCC 2705 and Gluten Sensitivity
A study testing Intervention 1 : BL NCC 2705 + Maltodextrin, Intervention 1 : Maltodextrin and Intervention 2 : BL NCC 2705 + Maltodextrin in people with Celiac Disease and Non-celiac Gluten Sensitivity, run by Société des Produits Nestlé (SPN) at 1 site in Netherlands.
Trial summary
The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease, Non-celiac Gluten Sensitivity
- What is being tested?
- Intervention 1 : BL NCC 2705 + Maltodextrin, Intervention 1 : Maltodextrin and Intervention 2 : BL NCC 2705 + Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Oct 2018to 15 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to sign written informed consent prior to trial entry
- Male or female adults >18 years of age
- For NCGS: self-reported gluten sensitivity with negative CD serology, on gluten free diet for at least 6 weeks with self-reported significant symptomatic improvement
- For CD: confirmed serologic and histologic diagnosis of CD and on GFD for at least 12 months with self-reported significant symptomatic improvement
- Body Mass Index (BMI) within the range >18 - <30 kg/m2
- Willing and able to comply with study procedures and restrictions
- In good health as determined by a medical history and medical examination
Who cannot join
- Documented IgE-mediated food allergy
- Subjects following an overly imbalanced or restrictive diet as per nutritional advice
- Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be detrimental for the participants safety or potentially interfering with the study procedures and/or study outcomes
- Concurrent organic GI pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli
- Previous abdominal surgery with the exception of hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, hemorrhoidectomy
- Patients who received antibiotics in the previous 2 weeks
- women of childbearing potential not willing to use an effective contraception method
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof of Concept Clinical Trial of Safety and Biological Activity of Bifidobacterium Longum NCC 2705 in Gluten Sensitivity
The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.
Read the detailed description
This trial is a multicenter, double blind, randomized, placebo controlled, 2 by 2 cross-over design (i.e. 2-sequences, 2-periods, 2-treatments) for each specific population (i.e. self-reported Non Coeliac Gluten Sensitivity and Coeliac Disease subjects).
1 capsule of BL NCC 2705 or placebo will be given twice a day in the morning and in the evening with a meal over 2 periods of 4 days.
On day four a single dose of gluten (3g) will be administered and duodenal fluid will be collected in the following hours through a naso-intestinal catheter. The viability of BL NCC 2705, the production of serpin and its effects on gluten digestion and intestinal enzymatic activity will be determined.
No chronic administration of gluten as a challenge is foreseen in the study.
After a wash out period of minimum 2 weeks, period will be repeated.
- Conditions
- Celiac Disease, Non-celiac Gluten Sensitivity
- Being tested
- Intervention 1 : BL NCC 2705 + Maltodextrin, Intervention 1 : Maltodextrin, Intervention 2 : BL NCC 2705 + Maltodextrin, Intervention 2 : Maltodextrin
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1 : BL NCC 2705 + MaltodextrinDietary supplement
2 capsules of BL NCC 2705/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of BL NCC 2705 in the morning of the 4th day
Intervention 1 : MaltodextrinOther
2 capsules of Placebo/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of Placebo in the morning of the 4th day
Intervention 2 : BL NCC 2705 + MaltodextrinDietary supplement
2 capsules of BL NCC 2705/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of BL NCC 2705 in the morning of the 4th day
Intervention 2 : MaltodextrinOther
2 capsules of Placebo/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of Placebo in the morning of the 4th day
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Placebo - Period 2: BL NCC 2705 | Other | For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity) Receives: Other: Intervention 1 : Maltodextrin; Dietary Supplement: Intervention 2 : BL NCC 2705 + Maltodextrin |
| Period 1: BL NCC 2705 - Period 2: Placebo | Other | For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity) Receives: Dietary Supplement: Intervention 1 : BL NCC 2705 + Maltodextrin; Other: Intervention 2 : Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence, type and severity of adverse event
incidence, type and severity of adverse event
Measured: from Baseline to end of study (up to maximum 43 days)
Gastro-intestinal tolerability: visual analog scale
Sum of visual analog scale for gastro-intestinal symptoms assessment (nausea, vomiting, diarrhea, audible bowel sound, flatulence and abdominal cramping symptoms are assessed). Each scale is from 0 (no symptom) to 100mm (maximum symptom). The maximum sum value is 600.
Measured: from Baseline to end of study (up to maximum 43 days)
Secondary outcomes (5)
Concentration of bacterial Serpin RNA and/or proteins (ng/mL) in duodenal aspirates
Measurements via RT-PRC and immuno-assay
Measured: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Concentration of Probiotic BL NCC 2705 (ng/mL) in duodenal aspirates
Measurements via PCR
Measured: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Concentration of gluten derived pepides in duodenal aspirates
Effect of BL NCC 2705 on gluten digestion based on the amount of gluten peptides detected in duodenal apsirates
Measured: 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Concentration of gluten derived pepides in urine
Effect of BL NCC 2705 on gluten digestion based on the amount of gluten peptides detected in urine
Measured: 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Level of elastase (Units/ mL) activity in duodenal aspirates
Measurements of proteolytic activity based assay
Measured: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start9 Oct 2018
- Primary completion4 Oct 2019
- Study completion15 Dec 2020
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carmine D'Urzo, Dr., Study director, Nestec Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775499
- Sponsor's protocol ID
- 17.11.NRC
- Status last verified
- Dec 2020
- First submitted
- 1 Nov 2018
- Last updated
- 23 Dec 2020
- 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 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Clinical Trial of Safety and Biological Activity of Bifidobacterium Longum NCC 2705 in Gluten Sensitivity
- ClinicalTrials.gov ID
- NCT03775499
- Acronym / sponsor ID
- 17.11.NRC
- Conditions
- Celiac Disease, Non-celiac Gluten Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 14 Dec 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.
The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.
Detailed description
This trial is a multicenter, double blind, randomized, placebo controlled, 2 by 2 cross-over design (i.e. 2-sequences, 2-periods, 2-treatments) for each specific population (i.e. self-reported Non Coeliac Gluten Sensitivity and Coeliac Disease subjects).
1 capsule of BL NCC 2705 or placebo will be given twice a day in the morning and in the evening with a meal over 2 periods of 4 days.
On day four a single dose of gluten (3g) will be administered and duodenal fluid will be collected in the following hours through a naso-intestinal catheter. The viability of BL NCC 2705, the production of serpin and its effects on gluten digestion and intestinal enzymatic activity will be determined.
No chronic administration of gluten as a challenge is foreseen in the study.
After a wash out period of minimum 2 weeks, period will be repeated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: Placebo - Period 2: BL NCC 2705 | Other | Other: Intervention 1 : Maltodextrin, Dietary Supplement: Intervention 2 : BL NCC 2705 + MaltodextrinFor the 2 populations (Celiac and Non-Celiac Gluten Sensitivity) |
| Period 1: BL NCC 2705 - Period 2: Placebo | Other | Dietary Supplement: Intervention 1 : BL NCC 2705 + Maltodextrin, Other: Intervention 2 : MaltodextrinFor the 2 populations (Celiac and Non-Celiac Gluten Sensitivity) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to sign written informed consent prior to trial entry
- Male or female adults >18 years of age
- For NCGS: self-reported gluten sensitivity with negative CD serology, on gluten free diet for at least 6 weeks with self-reported significant symptomatic improvement
- For CD: confirmed serologic and histologic diagnosis of CD and on GFD for at least 12 months with self-reported significant symptomatic improvement
- Body Mass Index (BMI) within the range >18 - <30 kg/m2
Key exclusion criteria (7 listed)
- Documented IgE-mediated food allergy
- Subjects following an overly imbalanced or restrictive diet as per nutritional advice
- Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be detrimental for the participants safety or potentially interfering with the study procedures and/or study outcomes
- Concurrent organic GI pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli
- Previous abdominal surgery with the exception of hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, hemorrhoidectomy
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 |
|---|---|---|
| Intervention 1 : BL NCC 2705 + Maltodextrin2 capsules of BL NCC 2705/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of BL NCC 2705 in the morning of the 4th day | Dietary supplement | Period 1: BL NCC 2705 - Period 2: Placebo |
| Intervention 1 : Maltodextrin2 capsules of Placebo/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of Placebo in the morning of the 4th day | Other | Period 1: Placebo - Period 2: BL NCC 2705 |
| Intervention 2 : BL NCC 2705 + Maltodextrin2 capsules of BL NCC 2705/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of BL NCC 2705 in the morning of the 4th day | Dietary supplement | Period 1: Placebo - Period 2: BL NCC 2705 |
| Intervention 2 : Maltodextrin2 capsules of Placebo/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of Placebo in the morning of the 4th day | Other | Period 1: BL NCC 2705 - Period 2: Placebo |
Primary outcome
incidence, type and severity of adverse event
Time frame: from Baseline to end of study (up to maximum 43 days)
incidence, type and severity of adverse event
Gastro-intestinal tolerability: visual analog scale
Time frame: from Baseline to end of study (up to maximum 43 days)
Sum of visual analog scale for gastro-intestinal symptoms assessment (nausea, vomiting, diarrhea, audible bowel sound, flatulence and abdominal cramping symptoms are assessed). Each scale is from 0 (no symptom) to 100mm (maximum symptom). The maximum sum value is 600.
5 secondary outcomes
Concentration of bacterial Serpin RNA and/or proteins (ng/mL) in duodenal aspirates
Time frame: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Concentration of Probiotic BL NCC 2705 (ng/mL) in duodenal aspirates
Time frame: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Concentration of gluten derived pepides in duodenal aspirates
Time frame: 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Concentration of gluten derived pepides in urine
Time frame: 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Level of elastase (Units/ mL) activity in duodenal aspirates
Time frame: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
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 23 Dec 2020.
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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.
Carmine D'Urzo, Dr. study director
Nestec Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 : BL NCC 2705 + Maltodextrin, Intervention 1 : Maltodextrin and Intervention 2 : BL NCC 2705 + Maltodextrin in people with Celiac Disease and Non-celiac Gluten Sensitivity, run by Société des Produits Nestlé (SPN) at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 23 Dec 2020. 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 Netherlands. 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?
incidence, type and severity of adverse event (time frame: from Baseline to end of study (up to maximum 43 days)). 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 23 Dec 2020.