Kurzdarmsyndrom

Die Studie

The purpose of this study is...

• You are a healthy male or female and you use no hormonal contraception.
• You are minimal 18 and maximal 45 years old.
• Your weight is at least 50 kg and your body Mass Index (BMI) is between 18.0 and 30.0 kg/m2. 
• Both non-smokers and light smokers or occasional smokers (who smoke no more than 5 cigarettes per day) are allowed to participate in this clinical trial. During your stay in the research facility smoking is not allowed.

Note: 

• You cannot participate in the trial if you have participated in another clinical trial in the 3 months prior to screening in the research facility (counting from the follow-up).
• For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 14 days prior to the start and during this trial.
• To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:

• You are not sexually active;
• You have passed the menopause (no periods for at least 12 months);
• You have been sterilized or your male partner has been sterilized;
• You are only sexually active with a partner of the same sex.

As a male you can only participate if you meet one of the following conditions:

• You are using a condom in combination with an additional contraception method used by your fertile female partner (hormonal contraceptives or a (copper) intra-uterine device);
• You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
• You are not sexually active;
• You are only sexually active with a partner of the same sex.

Zeitraum

• The trial consists of 2 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6). The first period is 3 days (2 nights), the second period is 4 days (3 nights). The follow-up visit will take place 9 to 13 days after the second departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial. 

Aufwandsentschädigung

• You will receive a gross compensation of €1776 for participation in this trial.

Travel expenses will be reimbursed based on the distance traveled (€ 0,21 net per kilometer) with a minimum of € 13 and a maximum of € 177 (840 kilometers) per round trip, regardless of the mode of transportation.