Celiac Disease Clinical Trial
Official title:
Proof of Concept Clinical Trial of Safety and Biological Activity of Bifidobacterium Longum NCC 2705 in Gluten Sensitivity
Verified date | December 2020 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.
Status | Completed |
Enrollment | 38 |
Est. completion date | December 15, 2020 |
Est. primary completion date | October 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Willing and able to sign written informed consent prior to trial entry 2. Male or female adults >18 years of age 3. 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 4. For CD: confirmed serologic and histologic diagnosis of CD and on GFD for at least 12 months with self-reported significant symptomatic improvement 5. Body Mass Index (BMI) within the range >18 - <30 kg/m2 6. Willing and able to comply with study procedures and restrictions 7. In good health as determined by a medical history and medical examination Exclusion Criteria: 1. Documented IgE-mediated food allergy 2. Subjects following an overly imbalanced or restrictive diet as per nutritional advice 3. 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 4. Concurrent organic GI pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli 5. Previous abdominal surgery with the exception of hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, hemorrhoidectomy 6. Patients who received antibiotics in the previous 2 weeks 7. women of childbearing potential not willing to use an effective contraception method |
Country | Name | City | State |
---|---|---|---|
Netherlands | Viecuri Hospital | Venlo |
Lead Sponsor | Collaborator |
---|---|
Nestlé |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence, type and severity of adverse event | incidence, type and severity of adverse event | from Baseline to end of study (up to maximum 43 days) | |
Primary | 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. | from Baseline to end of study (up to maximum 43 days) | |
Secondary | Concentration of bacterial Serpin RNA and/or proteins (ng/mL) in duodenal aspirates | Measurements via RT-PRC and immuno-assay | 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36) | |
Secondary | Concentration of Probiotic BL NCC 2705 (ng/mL) in duodenal aspirates | Measurements via PCR | 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36) | |
Secondary | 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 | 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36) | |
Secondary | 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 | 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36) | |
Secondary | Level of elastase (Units/ mL) activity in duodenal aspirates | Measurements of proteolytic activity based assay | 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36) |
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