- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06155929
Traveler's Constipation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Traveler's constipation, which is characterized by the more hard and less frequent stools, is sparsely covered in the medical litterature. Only a few studies have examined this problem and the actual occurrence and extent of this problem is not known. Hypotheses about why travel constipation occurs are, among other things, about changed circadian rhythm due to jet lag, changed schedules and tight sanitary conditions. Other factors such as dehydration, change in cabin pressure and the content of the in-flight food in connection with flights have not been investigated.
The research project aims to clarify changes in the test subjects' bowel habits as well as other gastrointestinal-related discomforts in connection with a flight abroad with only an hour's time difference and without the consumption of flight food.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Danmark
-
Herlev, Danmark, Denmark, 2730
- Herlev Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Can understand danish and is able to answer the questionnaires
- Given written consent
Exclusion Criteria:
- History of intestinal resection
- Medically treated intestinal disease
- IBS at baseline
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Flight
The intervention is the flight to turkey and home to Denmark again.
|
The participants are flying to turkey and back home.
The flights are the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stool frequency
Time Frame: 14 days
|
The investigators are sending questionnaires to the participants of the study to decide wether the stool frequency decreases after flight to turkey.
No scale used, simply time and number.
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bristol Stool Chart.
Time Frame: 14 days
|
The investigators are evaluating if the stool becomes less liquid indicating a prolonged transition time.
On er Likert scale from 1-7, 7 being most wet.
|
14 days
|
|
VAS-IBS: Visual Analog Scale for Irritable Bowel Syndrome
Time Frame: 14 days
|
Scale from 0-100 describing gastrointestinal bloating, pain and discomfort.
0 being good and 100 being bad
|
14 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F-23025419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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