Celiac Disease, Non-celiac Gluten Sensitivity
Conditions
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.
Interventions
OTHERIntervention 2 : Maltodextrin
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
DIETARY_SUPPLEMENTIntervention 1 : BL NCC 2705 + Maltodextrin
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
OTHERIntervention 1 : Maltodextrin
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
DIETARY_SUPPLEMENTIntervention 2 : BL NCC 2705 + Maltodextrin
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
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence, type and severity of adverse event | from Baseline to end of study (up to maximum 43 days) | incidence, type and severity of adverse event |
| Gastro-intestinal tolerability: visual analog scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of gluten derived pepides in duodenal aspirates | 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36) | Effect of BL NCC 2705 on gluten digestion based on the amount of gluten peptides detected in duodenal apsirates |
| Concentration of bacterial Serpin RNA and/or proteins (ng/mL) in duodenal aspirates | 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36) | Measurements via RT-PRC and immuno-assay |
| Level of elastase (Units/ mL) activity in duodenal aspirates | 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36) | Measurements of proteolytic activity based assay |
| Concentration of gluten derived pepides in urine | 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36) | Effect of BL NCC 2705 on gluten digestion based on the amount of gluten peptides detected in urine |
| Concentration of Probiotic BL NCC 2705 (ng/mL) in duodenal aspirates | 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36) | Measurements via PCR |
Countries
Netherlands
Outcome results
None listed