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Probiotic Blend for Celiac Disease

Primary Purpose

Celiac Disease

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Probiotic blend
Placebo
Sponsored by
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring probiotic, gastrointestinal symptoms, life quality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade do Extremo Sul CatarinenseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Treatment

Arm Description

vehicle only - Maltodextrin gluten free

Bifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863; Streptococcus thermophilus ATCC 19258) Final concentration: 1 x 10e10 CFU/ day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 17, 2022
Last Updated
December 2, 2022
Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Collaborators
Alexandre Faraco
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1. Study Identification

Unique Protocol Identification Number
NCT05646823
Brief Title
Probiotic Blend for Celiac Disease
Official Title
A Probiotic Blend in the Improvement of Gastrointestinal Symptoms and Life Quality in Patients With Celiac Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
April 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Collaborators
Alexandre Faraco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
probiotic, gastrointestinal symptoms, life quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
vehicle only - Maltodextrin gluten free
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Bifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863; Streptococcus thermophilus ATCC 19258) Final concentration: 1 x 10e10 CFU/ day
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic blend
Intervention Description
Bifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863; Streptococcus thermophilus ATCC 19258) Final concentration: 1 x 10e10 CFU/ day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
vehicle only - Maltodextrin gluten free
Primary Outcome Measure Information:
Title
gastrointestinal symptom
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Life quality
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Universidade do Extremo Sul Catarinense
City
Criciúma
State/Province
Santa Catarina
ZIP/Postal Code
88806-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monique Michels
Phone
+55 48 996274651
Email
monique@biohall.com.br

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only this study

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Probiotic Blend for Celiac Disease

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