In vivo study on the use of manganese gluconate for contrasting food in the gastrointestinal tract
- Conditions
- Investigation of the contrast of manganese gluconate solution against food in the gastrointestinal tract.
- Registration Number
- DRKS00031936
- Lead Sponsor
- niversität Greifswald, Institut für Pharmazie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9
BMI: > 18 kg/m² and < 30 kg/m²
Weight: min. 50 kg
Good health, assessed by the investigator as not deviating from the norm in clinical terms.
Presence of written informed consent.
- Disorders/diseases affecting the swallowing process (e.g. severe dysphagia with regard to food and/or solid oral dosage forms).
- claustrophobia
- Gastrointestinal disease and/or pathological changes that may interfere with gastric emptying.
- Known or suspected stenosis, fistulae or mechanical obstruction within the gastrointestinal tract.
- diseases of the liver
- Surgical procedures on the gastrointestinal tract within the last 12 months
- inflammatory bowel disease (Crohn's disease, ulcerative colitis or diverticulitis)
- Implanted or portable electromechanical medical devices such as a pacemaker, defibrillator or infusion pump
- Tattoos
- Known allergies or intolerances to the ingredients of meals
- Persons who are unable to consume an appropriately sized portion of a meal in a given amount of time
- Alcohol or drug addiction
- Smokers with a cigarette consumption of more than 10 cigarettes per day
- Eating disorders such as anorexia, bulimia
- positive pregnancy test or gravidity
- Persons who are known to be unwilling or unable to follow instructions reliably
- Individuals who are unable to understand written and verbal instructions and warnings regarding the study risks they face
- less than 14 days after acute illness
- systemic use of medications, especially those that affect gastrointestinal function
- known allergy or hypersensitivity to components of the dosage form
During the study and for 4 weeks prior to the study, no medications that influence gastrointestinal motility and gastric function may be taken. Deviations from this rule are possible if there are at least 10 half-lives between the last intake of the drug and the start of the study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time-dependent and absolute development of the contrast between manganese gluconate-laced fluid, surrounding tissue and food pulp.
- Secondary Outcome Measures
Name Time Method Site-time evaluation of fluid in the gastrointestinal tract.