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Recruiting NCT05646823

Probiotic Blend for Celiac Disease

Conditions: Celiac Disease

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: PHASE2
Enrollment: 118
Sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Location: Brazil

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05646823). StuddyBuddy aggregates publicly available trial information.