Status:
COMPLETED
Probiotic BL NCC 2705 and Gluten Sensitivity
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Celiac Disease
Non-celiac Gluten Sensitivity
Eligibility:
All Genders
18+ years
Phase:
NA
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 Coe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03775499
Start Date
October 9 2018
End Date
December 15 2020
Last Update
December 23 2020
Active Locations (1)
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1
Viecuri Hospital
Venlo, Netherlands