ConstipationNCT06155929
Traveler's Constipation
A study testing Flight in people with Constipation and Travel-Related Illness, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The occurence of traveler's constipation is sparsely covered in the medical litterature. This study aims to determine the gastrointestinal-related discomforts related to traveling on a trip to Turkey. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Travel-Related Illness
- What is being tested?
- Flight
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 2 May 2023to 20 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Can understand danish and is able to answer the questionnaires
- Given written consent
Who cannot join
- History of intestinal resection
- Medically treated intestinal disease
- IBS at baseline
Trial locations and contacts
1 site in 1 country.
About this study
The occurence of traveler's constipation is sparsely covered in the medical litterature. This study aims to determine the gastrointestinal-related discomforts related to traveling on a trip to Turkey.
Read the 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.
- Conditions
- Constipation, Travel-Related Illness
- Being tested
- Flight
- Medical subject headings
- Constipation, Travel-Related Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlightBehavioural
The participants are flying to turkey and back home. The flights are the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Flight | Other | The intervention is the flight to turkey and home to Denmark again. Receives: Behavioral: Flight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
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.
Measured: 14 days
Secondary outcomes (2)
Bristol Stool Chart.
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.
Measured: 14 days
VAS-IBS: Visual Analog Scale for Irritable Bowel Syndrome
Scale from 0-100 describing gastrointestinal bloating, pain and discomfort. 0 being good and 100 being bad
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start2 May 2023
- Primary completion20 May 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators are investigating wether a flight abroad is causing a decrease in stools.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Hansen, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155929
- Sponsor's protocol ID
- F-23025419
- Status last verified
- Nov 2023
- First submitted
- 27 Apr 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traveler's Constipation
- ClinicalTrials.gov ID
- NCT06155929
- Acronym / sponsor ID
- F-23025419
- Conditions
- Constipation, Travel-Related Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The occurence of traveler's constipation is sparsely covered in the medical litterature. This study aims to determine the gastrointestinal-related discomforts related to traveling on a trip to Turkey.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators are investigating wether a flight abroad is causing a decrease in stools.
| Arm | Type | Receives |
|---|---|---|
| Flight | Other | Behavioral: FlightThe intervention is the flight to turkey and home to Denmark again. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Can understand danish and is able to answer the questionnaires
- Given written consent
Key exclusion criteria (3 listed)
- History of intestinal resection
- Medically treated intestinal disease
- IBS at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlightThe participants are flying to turkey and back home. The flights are the intervention. | Behavioural | Flight |
Primary outcome
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.
2 secondary outcomes
Bristol Stool Chart.
Time frame: 14 days
VAS-IBS: Visual Analog Scale for Irritable Bowel Syndrome
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flight in people with Constipation and Travel-Related Illness, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool frequency (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.