Probiotic BL NCC 2705 and Gluten Sensitivity

Proof of Concept Clinical Trial of Safety and Biological Activity of Bifidobacterium Longum NCC 2705 in Gluten Sensitivity

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.

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