Clinical trial NCT03775499: Probiotic BL NCC 2705 and Gluten Sensitivity
Official title: Proof of Concept Clinical Trial of Safety and Biological Activity of Bifidobacterium Longum NCC 2705 in Gluten Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Non-celiac Gluten Sensitivity
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-12-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence, type and severity of adverse event
timeFrame: from Baseline to end of study (up to maximum 43 days)
measure: Gastro-intestinal tolerability: visual analog scale
timeFrame: from Baseline to end of study (up to maximum 43 days)
Secondary outcomes:
measure: Concentration of bacterial Serpin RNA and/or proteins (ng/mL) in duodenal aspirates
timeFrame: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
measure: Concentration of Probiotic BL NCC 2705 (ng/mL) in duodenal aspirates
timeFrame: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
measure: Concentration of gluten derived pepides in duodenal aspirates
timeFrame: 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36)
measure: Concentration of gluten derived pepides in urine
timeFrame: 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36)
measure: Level of elastase (Units/ mL) activity in duodenal aspirates
timeFrame: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)
Other outcomes:
Locations:
city: Venlo
country: Netherlands
facility: Viecuri Hospital
Study officials:
affiliation: Nestec Ltd.
name: Carmine D'Urzo, Dr.
role: STUDY_DIRECTOR
References: