Probiotic Blend for Celiac Disease

NCT05646823 | Unknown Phase 2 DMC

• 1 other identifier: UESCatarinense
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

probiotic; gastrointestinal symptoms; life quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Life quality

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

vehicle only - Maltodextrin gluten free

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

Dietary Supplement: Probiotic blend

Interventions

Probiotic blend DIETARY_SUPPLEMENT

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

Treatment

Placebo DIETARY_SUPPLEMENT

vehicle only - Maltodextrin gluten free

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude: lead
• Alexandre Faraco: collaborator

Study Sites (1)

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, 88806-000, Brazil

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 12, 2022
• Study Start: November 17, 2022
• Primary Completion: November 17, 2022
• Study Completion: April 17, 2023
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)