Other Clinical Trial - Infant Sleep Behaviour & Gut Microbacteria

Clinical Trial Summary

The overarching study aim is to evaluate the development of sleep behavior and gut microbiota (GMB), and their potential interaction, during the vulnerable period of the first year of life. Age-specific fecal profiles with bacterial genome sequencing will provide new insight into the functional coevolution of the GMB and host sleep behavior.

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Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02836119
Study type	Observational
Source	University of Zurich
Contact	Sarah F. Schoch, M.Sc.
Phone	044 255 93 68
Email	babysleep@usz.ch
Status	Recruiting
Phase
Start date	July 2016
Completion date	December 2020

Infant Sleep Behaviour and Gut Microbacteria — SDEGU

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms