Traveler's Constipation | NCT06155929

Studies
Traveler's Constipation

NCT06155929

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Dec 5, 2023Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Constipation
Travel-Related Illness

Interventions

Flight

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2023Actual

Primary Completion Date

May 20, 2023Actual

Completion Date

May 20, 2023Actual

First Submitted Date

Apr 27, 2023

First Submission Date that Met QC Criteria

Nov 24, 2023

First Posted Date

Dec 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2023

Last Update Posted Date

Dec 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Flight	Other	The intervention is the flight to turkey and home to Denmark again.	Behavioral: Flight

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flight	Behavioral	The participants are flying to turkey and back home. The flights are the intervention.	Flight

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	14 days
VAS-IBS: Visual Analog Scale for Irritable Bowel Syndrome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev Hospital		Herlev	Danmark	2730	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation
D000076082	Travel-Related Illness

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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