Proof of concept clinical trial of safety and biological activity of Bifidobacterium Longum NCC 2705 in gluten sensitivity

Completed

Conditions: celiac disease
gluten sensitivity
10016950

Registration Number: NL-OMON46135

Lead Sponsor: estec

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 38

Inclusion Criteria

1. Willing and able to sign written informed consent prior to trial entry
2. Male or female adults at a minimum age of 18
3. For NCGS: self-reported gluten sensitivity 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Adverse Events (AE) incidence, type, severity and causal relationship to the<br /><br>investigational product<br /><br>2) GI scores from a Visual Analogue Scale (VAS) over both treatment periods at<br /><br>home (i.e. from day 1 to day 3) for each symptom of interest (i.e. 1) nausea,<br /><br>2) vomiting, 3) diarrhea, 4) audible bowel sounds, 5) flatulence, 6) abdominal<br /><br>cramping)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Concentration of serpin in duodenal aspirates<br /><br>2) Concentration of BL NCC 2705 in duodenal aspirates<br /><br>3) Inhibition of the elastase activity in duodenal aspirates<br /><br>4) Concentration immunogenic (33-mer) gluten-derived peptides in duodenal<br /><br>aspirates following a 3g gluten containing meal<br /><br>5) Inhibition of glutenasic activity in duodenal aspirates<br /><br>6) Urinary excretion of immunogenic (33-mer) gluten-peptides following the<br /><br>gluten-containing meal </p><br>