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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
38
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
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
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
Viecuri Hospital
Venlo, Netherlands
incidence, type and severity of adverse event
incidence, type and severity of adverse event
Time frame: 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.
Time frame: from Baseline to end of study (up to maximum 43 days)
Concentration of bacterial Serpin RNA and/or proteins (ng/mL) in duodenal aspirates
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)
Concentration of Probiotic BL NCC 2705 (ng/mL) in duodenal aspirates
Measurements via PCR
Time frame: 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
Time frame: 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
Time frame: 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36)
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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
Level of elastase (Units/ mL) activity in duodenal aspirates
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)