Back to resultsProbiotic BL NCC 2705 and Gluten Sensitivity
Primary Purpose
Celiac Disease, Non-celiac Gluten Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intervention 1 : BL NCC 2705 + Maltodextrin
Intervention 1 : Maltodextrin
Intervention 2 : BL NCC 2705 + Maltodextrin
Intervention 2 : Maltodextrin
Sponsored by
About this trial
This is an interventional supportive care trial for Celiac Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Viecuri Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Period 1: Placebo - Period 2: BL NCC 2705
Period 1: BL NCC 2705 - Period 2: Placebo
Arm Description
For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)
For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)
Outcomes
Primary Outcome Measures
incidence, type and severity of adverse event
incidence, type and severity of adverse event
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.
Secondary Outcome Measures
Concentration of bacterial Serpin RNA and/or proteins (ng/mL) in duodenal aspirates
Measurements via RT-PRC and immuno-assay
Concentration of Probiotic BL NCC 2705 (ng/mL) in duodenal aspirates
Measurements via PCR
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
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
Level of elastase (Units/ mL) activity in duodenal aspirates
Measurements of proteolytic activity based assay
Full Information
NCT ID
NCT03775499
First Posted
November 1, 2018
Last Updated
December 22, 2020
Sponsor
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT03775499
Brief Title
Probiotic BL NCC 2705 and Gluten Sensitivity
Official Title
Proof of Concept Clinical Trial of Safety and Biological Activity of Bifidobacterium Longum NCC 2705 in Gluten Sensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
October 4, 2019 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Non-celiac Gluten Sensitivity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Period 1: Placebo - Period 2: BL NCC 2705
Arm Type
Other
Arm Description
For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)
Arm Title
Period 1: BL NCC 2705 - Period 2: Placebo
Arm Type
Other
Arm Description
For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention 1 : BL NCC 2705 + Maltodextrin
Intervention Description
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 Type
Other
Intervention Name(s)
Intervention 1 : Maltodextrin
Intervention Description
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 Type
Dietary Supplement
Intervention Name(s)
Intervention 2 : BL NCC 2705 + Maltodextrin
Intervention Description
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 Type
Other
Intervention Name(s)
Intervention 2 : Maltodextrin
Intervention Description
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
Primary Outcome Measure Information:
Title
incidence, type and severity of adverse event
Description
incidence, type and severity of adverse event
Time Frame
from Baseline to end of study (up to maximum 43 days)
Title
Gastro-intestinal tolerability: visual analog scale
Description
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.
Time Frame
from Baseline to end of study (up to maximum 43 days)
Secondary Outcome Measure Information:
Title
Concentration of bacterial Serpin RNA and/or proteins (ng/mL) in duodenal aspirates
Description
Measurements via RT-PRC and immuno-assay
Time Frame
19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Title
Concentration of Probiotic BL NCC 2705 (ng/mL) in duodenal aspirates
Description
Measurements via PCR
Time Frame
19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Title
Concentration of gluten derived pepides in duodenal aspirates
Description
Effect of BL NCC 2705 on gluten digestion based on the amount of gluten peptides detected in duodenal apsirates
Time Frame
10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Title
Concentration of gluten derived pepides in urine
Description
Effect of BL NCC 2705 on gluten digestion based on the amount of gluten peptides detected in urine
Time Frame
10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Title
Level of elastase (Units/ mL) activity in duodenal aspirates
Description
Measurements of proteolytic activity based assay
Time Frame
19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmine D'Urzo, Dr.
Organizational Affiliation
Nestec Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Viecuri Hospital
City
Venlo
Country
Netherlands
12. IPD Sharing Statement
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Probiotic BL NCC 2705 and Gluten Sensitivity
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