Probiotic BL NCC 2705 and Gluten Sensitivity

NCT03775499 | Completed

• 1 other identifier: 17.11.NRC
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Celiac Disease; Non-celiac Gluten Sensitivity

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (5)

• Concentration of bacterial Serpin RNA and/or proteins (ng/mL) in duodenal aspirates

  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

  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

  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

  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

  19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36)

Study Arms (2)

Period 1: Placebo - Period 2: BL NCC 2705

OTHER

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

Other: Intervention 1 : Maltodextrin; Dietary Supplement: Intervention 2 : BL NCC 2705 + Maltodextrin

Period 1: BL NCC 2705 - Period 2: Placebo

OTHER

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

Dietary Supplement: Intervention 1 : BL NCC 2705 + Maltodextrin; Other: Intervention 2 : Maltodextrin

Interventions

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

Period 1: BL NCC 2705 - Period 2: Placebo

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

Period 1: Placebo - Period 2: BL NCC 2705

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

Period 1: Placebo - Period 2: BL NCC 2705

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

Period 1: BL NCC 2705 - Period 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to sign written informed consent prior to trial entry
• Male or female adults \>18 years of age
• 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
• For CD: confirmed serologic and histologic diagnosis of CD and on GFD for at least 12 months with self-reported significant symptomatic improvement
• Body Mass Index (BMI) within the range \>18 - \<30 kg/m2
• Willing and able to comply with study procedures and restrictions
• In good health as determined by a medical history and medical examination

You may not qualify if:

• Documented IgE-mediated food allergy
• Subjects following an overly imbalanced or restrictive diet as per nutritional advice
• 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
• Concurrent organic GI pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli
• Previous abdominal surgery with the exception of hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, hemorrhoidectomy
• Patients who received antibiotics in the previous 2 weeks
• women of childbearing potential not willing to use an effective contraception method

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Viecuri Hospital

Venlo, Netherlands

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Carmine D'Urzo, Dr.

  Nestec Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: December 14, 2018
• Study Start: October 9, 2018
• Primary Completion: October 4, 2019
• Study Completion: December 15, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

NL (1)