Gluten degrading-probiotic in the dietary management of symptomatic Celiac disease patients: a randomized, multicentric, placebo-controlled, double-blinded study

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

BMI 17.5 – 35 kg/m2
- Non-smoker
- Past celiac disease diagnosis confirmed by medical report
- Gluten free diet (GFD) for at least two years
- Celiac disease patients with persistent IBS-type symptoms with no clinical evidence of other medical conditions to explain the symptoms
- IBS-SSS score of at least mild symptoms (IBS-SSS score = 75) during screening assessment
- Apart from celiac disease diagnosis, subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, haematology
- Written consent to participate in the study
- Able and willing to follow the study procedures
- Visit 1: Confirmed at least mild symptoms during run-in phase (on average IBS-SSS score > 50)

Exclusion Criteria

(1) Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
(2) Subject under prescription for medication or taking dietary supplements possibly interfering with this study (such as corticosteroids, anti-inflammatory drugs, anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, fibers, probiotics etc.) within 4 weeks prior to study start or during the study. Stable doses of vitamin and mineral dietary supplements for at least 3 months is allowed.
(3) Intake of antibiotics in the last 3 months
(4) Use of PPIs in the last month prior to screening
(5) Significant changes in lifestyle or medication (within last 2 months) or surgical intervention
(6) Subjects consuming
• food or drinks claimed as ‘probiotic’ more than once weekly
• protein shakes more than once weekly
(7) Subjects with stool frequency of = 2 stools per week
(8) Subjects with history of drug, alcohol or other substance abuse within the last 5 years
(9) Relevant allergy or known hypersensitivity against compounds of the study preparations
(10) Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
(11) Anticipating any planned major changes in lifestyle, dietary habits or physical activity levels for the duration of the study
(12) Known pregnancy, breastfeeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and all visits at the study site
(13) Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IBS-SSS (rating system for the severity of irritable bowel symptoms); change in symptoms over a period of 8 weeks compared to placebo.

Secondary Outcome Measures

Name	Time	Method
GSRS-IBS - irritable bowel syndrome questionnaire (RDF) (Day 1, Day 29, Day 57, Day 71)<br>IBS-QoL (Irritable Bowel Syndrome Quality of Life Instrument) (Day 1, Day 29, Day 57, Day 71)<br>IBS-GAI: Global assessment of improvement scale (Day 29, Day 57, Day 71)<br>IBS-AR: Irritable bowel syndrome adequate relief (weekly assessment between Day 1 - Day 71)<br>Assessments of main symptoms to be assessed with a NRS (0-100) (weekly assessment between Day 1 - Day 71)<br>Bristol stool chart (weekly assessment between Day -14 - Day 71)<br>Responder rate based on IBS-SSS (Day 29, Day 57)<br>Biomarkers:<br>Fecal gluten content (Day 1, Day 57, Day 71)<br>Fecal microbiota composition (16S-rRNA analysis or shot gun)<br>Metabolomic fecal profile (Day 1, Day 57, Day 71)<br>Nutritional biomarkers (e.g. Zn) in blood and urine (Day 1, Day 57, Day 71)<br>Saliva microbiota composition (16S-rRNA) (Day 1, Day 57, Day 71)<br>