Examination of peristalsis and stomach emptying from young and healthy volunteers.
Conditions
Interventions
Group 1: Fasting ingestion of 240 mL of manganese(II) gluconate-labelled tap water and measurement of gastric motility and gastric emptying in real-time MRI. After 30 min, further ingestion of 50 mL o
Sponsors
Institute of Pharmacy Department of Biopharmaceutics and Pharmaceutical Technology University of Greifswald
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: BMI: between 18 kg/m² and 30 kg/m² good health, which is assessed by the investigator as not deviating from the norm in clinical terms Availability of the written declaration of consent
Exclusion criteria
Exclusion criteria: - Disorders/diseases affecting the swallowing process (e.g. severe dysphagia in relation to food and/or solid oral dosage forms) - claustrophobia - gastrointestinal diseases and/or pathological changes that could interfere with gastric emptying - Known or suspected stenoses, fistulas or mechanical obstructions within the gastrointestinal tract - Diseases of the liver - Surgical interventions 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 pacemakers, defibrillators or infusion pumps - Large dark tattoos - Known allergies or intolerances to the components of the fluids - 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 pregnancy - Persons who are known to be unwilling or unable to follow instructions reliably - Persons who are unable to understand written and verbal instructions and instructions regarding the study risks they face - less than 14 days after acute illness - Systemic intake of medications, especially those that affect the function of the gastrointestinal tract - Simultaneous participation in interventional research projects; the interval between previous participation in other studies should not be less than 14 days During the study and 4 weeks prior to the study, no drugs that affect 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. The drugs concerned include, among others - Laxatives - Antidiarrhoeals - Prokinetic antiemetics - Drugs with pronounced anticholinergic effects such as neuroleptics and antidepressants - Opioid analgesics - antibiotics - Antacids, proton pump inhibitors, H2 antihistamines - Calcium antagonists - beta blockers - nitrates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tracking and measurement of the liquid volume of manganese(II) gluconate-labelled tap water and the prevailing gastric peristalsis | — |
Secondary
| Measure | Time frame |
|---|---|
| Development of a method for evaluation | — |
Countries
Germany
Contacts
Public ContactWerner Weitschies
Institute of Pharmacy Department of Biopharmaceutics and Pharmaceutical Technology University of Greifswald
Outcome results
None listed