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Probiotic BL NCC 2705 and Gluten Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775499
Recruitment Status : Active, not recruiting
First Posted : December 14, 2018
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Nestlé

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

Condition or disease Intervention/treatment Phase
Celiac Disease Non-celiac Gluten Sensitivity Dietary Supplement: Intervention 1 : BL NCC 2705 + Maltodextrin Other: Intervention 1 : Maltodextrin Dietary Supplement: Intervention 2 : BL NCC 2705 + Maltodextrin Other: Intervention 2 : Maltodextrin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Proof of Concept Clinical Trial of Safety and Biological Activity of Bifidobacterium Longum NCC 2705 in Gluten Sensitivity
Actual Study Start Date : October 9, 2018
Actual Primary Completion Date : October 4, 2019
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Period 1: Placebo - Period 2: BL NCC 2705
For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)
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

Period 1: BL NCC 2705 - Period 2: Placebo
For the 2 populations (Celiac and Non-Celiac Gluten Sensitivity)
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 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




Primary Outcome Measures :
  1. incidence, type and severity of adverse event [ Time Frame: from Baseline to end of study (up to maximum 43 days) ]
    incidence, type and severity of adverse event

  2. Gastro-intestinal tolerability: visual analog scale [ Time Frame: from Baseline to end of study (up to maximum 43 days) ]
    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.


Secondary Outcome Measures :
  1. Concentration of bacterial Serpin RNA and/or proteins (ng/mL) in duodenal aspirates [ Time Frame: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36) ]
    Measurements via RT-PRC and immuno-assay

  2. Concentration of Probiotic BL NCC 2705 (ng/mL) in duodenal aspirates [ Time Frame: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36) ]
    Measurements via PCR

  3. Concentration of gluten derived pepides in duodenal aspirates [ Time Frame: 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36) ]
    Effect of BL NCC 2705 on gluten digestion based on the amount of gluten peptides detected in duodenal apsirates

  4. Concentration of gluten derived pepides in urine [ Time Frame: 10 sampling over 3h30 at visit 2 (day 4) and visit 3 (from day 22 to day 36) ]
    Effect of BL NCC 2705 on gluten digestion based on the amount of gluten peptides detected in urine

  5. Level of elastase (Units/ mL) activity in duodenal aspirates [ Time Frame: 19 sampling over 6h50 hours at visit 2 (day 4) and visit 3 (from day 22 to day 36) ]
    Measurements of proteolytic activity based assay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775499


Locations
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Netherlands
Viecuri Hospital
Venlo, Netherlands
Sponsors and Collaborators
Nestlé
Investigators
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Study Director: Carmine D'Urzo, Dr. Nestec Ltd.
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03775499    
Other Study ID Numbers: 17.11.NRC
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Hypersensitivity
Immune System Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases