Probiotic Blend for Celiac Disease

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to develop a probiotic product (B. longum CCT 1934; B. lactis CCT 7858; L. rhamnosus CCT 7863; S. thermophilus ATCC 19258) to reduce the symptoms caused by celiac disease and concomitantly improve the quality of life of patients. To achieve the objective, 118 volunteers of both sexes will be included, randomly distributed into two groups: Test group (n=59): Volunteers supplemented with the probiotic product (Bifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863 ; Streptococcus thermophilus ATCC 19258) Final concentration: 1 x 1010 CFU/ day) and Placebo group (n=59): Volunteers supplemented with placebo. The study will be conducted with patients diagnosed with celiac disease, the audience is adults (18 - 65 years old). The study will last for 90 days and volunteers will be invited to participate in three visits. During these visits, participants will be invited to answer the proposed questionnaires. The volunteer is expected to show improvement in gastrointestinal symptoms, as well as an improvement in quality of life after using the probiotic blend for 90 days.

Detailed Description
-----------------
Randomized, double-blind, placebo-controlled study to evaluate the effectiveness of a probiotic blend (Bifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863; Streptococcus thermophilus ATCC 19258) in improving gastrointestinal symptoms caused by celiac disease, as well as improvement in quality of life. Study will be conducted with patients diagnosed with celiac disease by the gastroenterologist participating in the study. Adult audience (18 - 65 years old). In the present study, 118 volunteers of both sexes will be included, randomly distributed into two groups. They will be randomized into: 1) Probiotics: (Bifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863; Streptococcus thermophilus ATCC 19258) Final concentration: 1 x 1010 CFU/day. 2)Placebo: Capsules containing the gluten-free product vehicle. The study will last for 90 daysVisit 1 (day 0) - Assessment of inclusion and exclusion criteria, clinical and physical evaluation, research presentation and signing of the Free Consent Form and Clarified in writing, partial delivery of the test product or placebo, delivery and application of questionnaires (quality of life questionnaires (CD-QOL scale) and Gastrointestinal Symptom Rating Scale (GSRS) questionnaire for gastrointestinal evaluation. The questionnaires will preferably be applied in a in person by the researchers involved (with scheduled time) in interview format, or online via Google Forms (if the volunteer so prefers), to be agreed with the volunteer. will follow the guidelines according to CIRCULAR LETTER No. 2/2021/CONEP/SECNS/MS, providing confidentiality to all information collected. In addition, an explanation will also be given on the first visit regarding the importance of the questionnaires, correct completion, and possible changes in the GIT in the first days of using the probiotic. Visit 2 (day 45) - Clinical consultation with a specialist physician, delivery final product test or placebo, and application of questionnaires.Visit 3 (day 90) - Clinical consultation with specialist physician and application of final questionnaires. Closure of the study.

Official Title
-----------------
A Probiotic Blend in the Improvement of Gastrointestinal Symptoms and Life Quality in Patients With Celiac Disease

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic blend
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of Free and Informed Consent in writing, signed and dated; Age according to the indicated population; Patients diagnosed with celiac disease by a specialist physician. Exclusion Criteria: History of daily consumption of probiotics, fermented milk and or yogurt; subjects known to have demonstrated a prior reaction, including anaphylaxis, to any substance in the composition of the study product; Subjects who have uncompensated blood pressure; history of heart disease, including valvular heart disease or any implantable device; subjects with active, uncontrolled bowel disease such as Crohn's disease or ulcerative colitis; another clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>vehicle only - Maltodextrin gluten free | Dietary Supplement: Placebo<br>* vehicle only - Maltodextrin gluten free<br>|
| Experimental: Treatment<br>Bifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863; Streptococcus thermophilus ATCC 19258) Final concentration: 1 x 10e10 CFU/ day | Dietary Supplement: Probiotic blend<br>* Bifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863; Streptococcus thermophilus ATCC 19258) Final concentration: 1 x 10e10 CFU/ day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastrointestinal symptom | The GSRS is a disease-specific instrument. The 15 items combine into five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The reliability and validity of the GSRS are well-documented, and norm values for a general population are available | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life quality | coeliac disease (CD)-related quality of life (QOL) test. CD-QOL has 20 items across four clinically relevant subscales (Limitations, Dysphoria, Health Concerns, and Inadequate Treatment). The CD-QOL has high internal consistency, reliability, and psychometric validation indicates both convergent and discriminate validity. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
probiotic, gastrointestinal symptoms, life quality