Blinding
COMPLICATIONS
The blinding is applied to the trial participants and the investigators, who serve as both care providers and outcome assessors.A treatment code table was generated via Winclove Probiotics B.V., Netherlands. Each Verum/Placebo box containing 50 sachets receives a unique code, corresponding to the treatment code table. The blinding of the sachet boxes is also done at Winclove Probiotics B.V., Amsterdam, Netherlands.To ensure proper stratification of the 20 individuals taking probiotics/placebos who also have two endoscopies during the trial, the randomisation is separated into two lists: The first list contains the 100 individuals without endoscopies, and the second list consists of the 20 participants that are assigned to the endoscopic procedures. The investigators have both lists available and assign participants the corresponding code in ascending order.Since we are only randomizing dietary supplements and placebos in a blinded manner in healthy participants, we do not expect any complications from the trial participation that would require emergency unblinding. However, in case of a medical emergency involving a participant of the trial, study investigators may be reached through the Endocrinology Ward, Division of Endocrinology and Diabetology, Medical University of Graz on a 24/7 basis.The randomization can be unblinded at the Endocrinology ward, where 120 sealed envelopes contain the allocation of each number. Only the envelope containing the treatment number for the patient in question may be opened. Both the principal investigator and the sponsor have to be notified as soon as possible of the emergency unblinding.