Probiotic BL NCC 2705 and Gluten Sensitivity

Study Purpose

The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03775499
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Nestlé
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Carmine D'Urzo, Dr.
Principal Investigator Affiliation	Nestec Ltd.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease, Non-celiac Gluten Sensitivity

Additional Details

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.

Arms & Interventions

Arms

Other: Period 1: Placebo - Period 2: BL NCC 2705

For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)

Other: Period 1: BL NCC 2705 - Period 2: Placebo

For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)

Interventions

Dietary Supplement: - Intervention 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

Other: - Intervention 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 Supplement: - Intervention 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

Other: - Intervention 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Viecuri Hospital, Venlo, Netherlands

Status

Recruiting

Address

Viecuri Hospital

Venlo, ,

Site Contact

Britt Otten

britt.otten@maastrichtuniversity.nl

+31 6 52 22 18 94

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