NCT06155929

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

18 days

First QC Date

April 27, 2023

Last Update Submit

November 24, 2023

Conditions

ConstipationTravel-Related Illness

Outcome Measures

Primary Outcomes (1)

  • 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.

    14 days

Secondary Outcomes (2)

  • Bristol Stool Chart.

    14 days

  • VAS-IBS: Visual Analog Scale for Irritable Bowel Syndrome

    14 days

Study Arms (1)

Flight

OTHER

The intervention is the flight to turkey and home to Denmark again.

Behavioral: Flight

Interventions

FlightBEHAVIORAL

The participants are flying to turkey and back home. The flights are the intervention.

Flight

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Can understand danish and is able to answer the questionnaires
  • Given written consent

You may not qualify if:

  • History of intestinal resection
  • Medically treated intestinal disease
  • IBS at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, Danmark, 2730, Denmark

Location

MeSH Terms

Conditions

ConstipationTravel-Related Illness

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The investigators are investigating wether a flight abroad is causing a decrease in stools.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical student

Study Record Dates

First Submitted

April 27, 2023

First Posted

December 5, 2023

Study Start

May 2, 2023

Primary Completion

May 20, 2023

Study Completion

May 20, 2023

Last Updated

December 5, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)