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Lactobacillus casei Shirota for influencing the microbiome of patients with Barrett's esophagus.

Lactobacillus casei Shirota for influencing the microbiome of patients with Barrett's esophagus. - The Yakult study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43164
Enrollment
20
Registered
2017-03-27
Start date
2017-04-18
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's esophagus

Interventions

Patients will be drinking 2 bottles per day of a LcS containing drink (Yakult), for a period of 4 weeks.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age > 18 years Histopathological proof of Barrett's esophagus (BE) without dysplasia BE length of >2 cm (C2Mx) Signed informed consent

Exclusion criteria

Exclusion criteria: Probiotic use within the last 3 months before baseline. Antibiotic use within the last 2 months before baseline. Infection in the oral cavity. Esophagitis according to the Los Angeles classification (gr. A-D) Immunocompromised patients; HIV-infection, systemic immunosuppression therapy Patients with diabetes mellitus Previous gastric/esophageal surgery, which has changed esophageal anatomy Other coexistent esophageal disease (e.g. varices) Patients with bleeding disorders Other situations that contraindicate gastroscopy

Design outcomes

Primary

MeasureTime frame
1. Amount of LcS bacteria (16S rDNA analysis) 2. Bacterial Gr+/Gr- ratio in the esophagus (both in BE and in squamous epithelium) (16S rDNA analysis of the esophageal flora (with and without LcS)).

Secondary

MeasureTime frame
3. Amount of pathogenic bacteria i.e. Campylobactor spp, Veilonella spp, Neisserria spp (16S rDNA sequencebased metagenomic analysis). 4. Immunological response to the change in microbiome (Micro-array based analysis of the expression profiles of immune responses gene). 5. Presence of inflammation (endoscopic observation).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)