search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Lactobacillus casei Shirota for influencing the microbiome in Barrett's esophagus


- candidate number28387
- NTR NumberNTR6950
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-dec-2017
- Secondary IDsNL59072.091.16 CMO Arnhem-Nijmegen
- Public TitleLactobacillus casei Shirota for influencing the microbiome in Barrett's esophagus
- Scientific TitleLactobacillus casei Shirota for influencing the microbiome of patients with Barrett's esophagus
- ACRONYMThe Yakult study
- hypothesis
- Healt Condition(s) or Problem(s) studiedBarrett's esophagus
- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-dec-2017
- planned closingdate1-sep-2018
- Target number of participants20
- InterventionsYakult 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.
- Primary outcomeThe 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-.
- Timepoints4 weeks
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD Yonne Peters
- CONTACT for SCIENTIFIC QUERIESMD Peter D. Siersema
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Yakult Nederland B.V. Handelsweg 59H 1181 ZA Amstelveen The Netherlands
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD28-dec-2017 - 26-jan-2018


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl