Primary Headaches and Irritable Bowel Syndrome.

September 24, 2021 updated by: Mohamed Gamal Helmy, Assiut University

Association Between Primary Headaches and Irritable Bowel Syndrome.

To assess the relationship between primary headaches and irritable bowel syndrome

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The association between primary headaches and functional gastrointestinal disorders has been confirmed by many clinical observations. In most patients during the attacks of headache, apart from various neurological and vascular symptoms, gastrointestinal disturbances occur . Functional gastrointestinal disorders, such as irritable bowel syndrome (IBS), are reported in primary headache patients in periods between the attacks as well. On the other hand 23-53% of IBS patients have frequent headaches.

Migraine typically presents relapsing episodes of symptoms including headache, nausea, vomiting, sensory hypersensitivity and mood changes that last for hours to days . Similar to migraine, IBS is characterized by recurrent abdominal pain or discomfort with altered gastrointestinal motility and visceral hypersensitivity that returns to normal between attacks . Both pain disorders lack detectable organic causes .

An emerging model of the brain-gut axis was proposed to explain migraine and IBS as a result of a genetically sensitive nervous system that develops hyperexcitability over time as a response to multiple environmental and immunological factors.

Cluster headache (CH) characterized by its distinctive circadian and circannual periodicity, implicating the role of the hypothalamus in its underlying pathophysiology. CH and IBS are featuring recurrent attacks of pain that possess relationships with circadian rhythms and potentially hypothalamic derangements.

Tension headache that's associated with pain in head described as feeling like a tight band around head, also show many similarities with IBS such causes for both are unknown, and some studies suggest a possible link that could shed light on shared genetics of both condition .

Study Type

Observational

Enrollment (Anticipated)

197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A group of patients attending headache outpatient clinic of Assuit University hospital diagnosed with primary headaches (migraine , tension Headache or cluster headache)according to a questionnaire based on diagnostic criteria established by the International Headache Society will interviewed with a questionnaire based on Rome IV Diagnostic criteria of IBS to detect the prevalence of IBS among patients with primary headaches

Description

Inclusion Criteria:

  • age more than 18.
  • both sex.
  • history suggestive of any type of primary headaches.
  • accept to participate in the study.

Exclusion Criteria:

  • Intake of medications that can aggravate Headache or IBS.
  • Presence of neurological disease other than primary headaches.
  • Presence of gastrointestinal disease other than IBS.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between primary headaches and irritable bowel syndrome
Time Frame: Basline
To Detect the prevalence of IBS among patients with primary headaches
Basline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subtypes of primary headachecs and IBS
Time Frame: Basline
Detect the intimate correlation between each type of primary headaches and IBS
Basline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Reda Badry, MD prof
  • Study Director: Wael Abbas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Primary Headaches and IBS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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