Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Placebo - Period 2: BL NCC 2705 | Other | For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity) |
|
| Period 1: BL NCC 2705 - Period 2: Placebo | Other | For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention 1 : BL NCC 2705 + Maltodextrin | Dietary 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Concentration of Probiotic BL NCC 2705 (ng/mL) in duodenal aspirates |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carmine D'Urzo, Dr. | Nestec Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viecuri Hospital | Venlo | Netherlands |
Not provided
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C008315 | maltodextrin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intervention 1 : Maltodextrin | Other | 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 + Maltodextrin | Dietary 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 : Maltodextrin | Other | 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 |
|
Measurements via PCR |
| 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 | 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 | 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 | 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36) |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |