Celiac DiseasePhase 2NCT05646823
Probiotic Blend for Celiac Disease
A Phase 2 study testing Probiotic blend in people with Celiac Disease, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Probiotic blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Nov 2022to 17 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade do Extremo Sul Catarinense
Criciúma, Santa Catarina, 88806-000
Monique Michels, +55 48 996274651, monique@biohall.com.br
About this study
Official title: A Probiotic Blend in the Improvement of Gastrointestinal Symptoms and Life Quality in Patients With Celiac Disease
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.
Read the 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.
- Conditions
- Celiac Disease
- Being tested
- Probiotic blend, Placebo
- Keywords
- probiotic, gastrointestinal symptoms, life quality
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic blendDietary supplement
Bifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863; Streptococcus thermophilus ATCC 19258) Final concentration: 1 x 10e10 CFU/ day
PlaceboDietary supplement
vehicle only - Maltodextrin gluten free
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | vehicle only - Maltodextrin gluten free Receives: Dietary Supplement: Placebo |
| Treatment | Experimental | Bifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863; Streptococcus thermophilus ATCC 19258) Final concentration: 1 x 10e10 CFU/ day Receives: Dietary Supplement: Probiotic blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start17 Nov 2022
- Primary completion17 Nov 2022
- Study completion17 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandre Faraco
- Responsible party
- Principal investigator, Monique Michels, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646823
- Sponsor's protocol ID
- UESCatarinense
- Status last verified
- Dec 2022
- First submitted
- 17 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only this study
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Probiotic Blend in the Improvement of Gastrointestinal Symptoms and Life Quality in Patients With Celiac Disease
- ClinicalTrials.gov ID
- NCT05646823
- Acronym / sponsor ID
- UESCatarinense
- Conditions
- Celiac Disease
- Keywords
- probiotic, gastrointestinal symptoms, life quality
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudeUniversity, hospital or other
- Collaborators
- Alexandre Faraco
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Apr 2023 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebovehicle only - Maltodextrin gluten free |
| Treatment | Experimental | Dietary Supplement: Probiotic blendBifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863; Streptococcus thermophilus ATCC 19258) Final concentration: 1 x 10e10 CFU/ day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic blendBifidobacterium longum CCT 1934; Bifidobacterium lactis CCT 7858; Lactobacillus rhamnosus CCT 7863; Streptococcus thermophilus ATCC 19258) Final concentration: 1 x 10e10 CFU/ day | Dietary supplement | Treatment |
| Placebovehicle only - Maltodextrin gluten free | Dietary supplement | Placebo |
Primary outcome
gastrointestinal symptom
Time frame: 12 weeks
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
1 secondary outcome
Life quality
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No. Only this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic blend in people with Celiac Disease, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastrointestinal symptom (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.