LcS is able to colonize the esophagus.
ID
Bron
Verkorte titel
Aandoening
Barrett's Esophagus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
LcS is able to colonize the esophagus.
Onderzoeksopzet
4 weeks
Onderzoeksproduct en/of interventie
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.
Publiek
Yonne Peters
P.O. box 9101
Nijmegen 6500 HB
The Netherlands
+31615956464
y.peters@radboudumc.nl
Wetenschappelijk
Yonne Peters
P.O. box 9101
Nijmegen 6500 HB
The Netherlands
+31615956464
y.peters@radboudumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age ≥ 18 years
- Histopathological proof of BE without dysplasia
- BE length of >2 cm (CxM2)
- Signed informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6620 |
| NTR-old | NTR6950 |
| CCMO | NL59072.091.16 |
| OMON | NL-OMON43164 |