No registrations found.
ID
Source
Brief title
Health condition
Barrett's Esophagus
Sponsors and support
Intervention
Outcome measures
Primary outcome
The ability of LcS to colonize the esophagus and if so, if we can see a shift in the Gr+(with and without LcS)/Gr- bacterial ratio to a more predominantly Gr+ microbiome.
Secondary outcome
- The number of specific pathogenic bacteria, i.e; Campylobacter spp, Veilonella spp, Neisseria spp. Fusobacterium spp and Prevotella spp.
- To explore the effect of restoration of the Gr+/Gr- on the local immunological response, i.e. IL-10, IL-18 and TGF-â.
Background summary
The aim of this study is to evaluate if LcS is capable of influencing the microbiome and thereby altering the inflammatory reaction in BE.
Study design: Pilot study, not randomized.
Study population: 20 Patients with BE without (prior) dysplasia, age ≥ 18 years.
Intervention: Patients will be drinking 2 bottles per day of a LcS containing drink (Yakult), for a period of 4 weeks.
Study objective
LcS is able to colonize the esophagus.
Study design
4 weeks
Intervention
Yakult is a fermented milk drink containing at least 6,5*10^9 Lactobacillus casei Shirota. The other ingredients are Water, Syrup (Glucose fructose syrup, sugar, Maltodextrin), Skimmed milk powder and flavouring. Yakult is gluten free.
Yonne Peters
P.O. box 9101
Nijmegen 6500 HB
The Netherlands
+31615956464
y.peters@radboudumc.nl
Yonne Peters
P.O. box 9101
Nijmegen 6500 HB
The Netherlands
+31615956464
y.peters@radboudumc.nl
Inclusion criteria
- Age ≥ 18 years
- Histopathological proof of BE without dysplasia
- BE length of >2 cm (CxM2)
- Signed informed consent
Exclusion criteria
- Probiotic use within the last 3 months before baseline
- Antibiotic use within the last 2 months before baseline
- Infection of the oral cavity
- Esophagitis according to the Los Angeles classification (gr. A-D)
- Patients with H. Pylori infection
- Immunocompromised patients; HIV-infection, systemic immunosuppression therapy
- Patients with diabetes mellitus
- Patients with a vegetarion or gluten-free diet
- Patients with lactose intolerance
- Previous gastric/esophageal surgery, which has changed esophageal anatomy.
- Other coexistent esophageal diseases (e.g. varices)
- Patients with bleeding disorders
- Other situations that contraindicate gastroscopy, e.g. anti-coagulants (monotherapy aspirin can be continued safely), the inability of the patients to cooperate with the procedure despite adequate attempts at sedation.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6620 |
| NTR-old | NTR6950 |
| CCMO | NL59072.091.16 |
| OMON | NL-OMON43164 |