Probiotic Blend for Celiac Disease

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Celiac Disease

Clinical Trial Details

NCT number	NCT05646823
Study type	Interventional
Source	Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Contact
Status	Recruiting
Phase	Phase 2
Start date	November 17, 2022
Completion date	April 17, 2023

View Details

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