Cognitive Modulation of Dyspeptic Symptom During Food Ingestion in Functional Dyspepsia Patients Cognitive Modulation
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|ClinicalTrials.gov Identifier: NCT02618070|
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : April 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Brain Imaging Functional Dyspepsia Food||Other: Yogurt||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Experimental: Functional dyspepsia patient
- functional brain activity [ Time Frame: 1-2 years ]
Resting BOLD (Blood oxygenation level-dependent) signal before and after yogurt ingestion will compared between groups.
There is a small risk of discomfort from claustrophobia, periods of immobility, and exposure to the noise of the magnet. The investigators will offer the participants ear plugs. In rare cases the participants experience dizziness, nausea, or tinnitus which normally disappear after the measurement. During the measurements there is the possibility of warming which could lead to skin irritation in people with tattoos. Therefore, the participants with tattoos will not be included. The participants are instructed to tell the investigators immediately if any uncomforted appears. The study will be performed by experienced experimenters who know all about the risks. During the measurements, the participants are monitored. As a commercial yogurt (200 ml) will be used, the investigators do not expect any side effects. Food allergy will be checked before.
- subjective rating [ Time Frame: 1-2 years ]The investigators will measure how much the participants have fullness, satiation, nausea and vomiting, pain, and their mood before and after the yogurt ingestion using visual analog scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618070
|Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany|
|Tuebingen, Germany, 72072|
|Principal Investigator:||Paul Enck, Prof.||Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany|