Primary Headaches and Irritable Bowel Syndrome.

NCT ID: NCT05057533

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To assess the relationship between primary headaches and irritable bowel syndrome

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Headache Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

a questionnaire based on Rome IV Diagnostic criteria of IBS

The Rome IV criteria for the diagnosis of IBS require that patients have had recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with two or more of the following

1. Related to defecation (may be increased or unchanged by defecation)
2. Associated with a change in stool frequency
3. Associated with a change in stool form or appearance The Rome IV criteria (May 2016) only require abdominal pain in defining this condition; "discomfort" is no longer a requirement owing to its nonspecificity, and the recurrent abdominal pain. \[2\] Supporting symptoms include the following:Altered stool frequency Altered stool form Altered stool passage (straining and/or urgency) Mucorrhea Abdominal bloating or subjective distention.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Gamal Helmy

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Reda Badry, MD prof

Role: STUDY_DIRECTOR

Wael Abbas

Role: STUDY_DIRECTOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut University hospital

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed Helmy, Resident doctor

Role: CONTACT

+201018517954

Wafaa Fargaly, MD prof

Role: CONTACT

+201000104904

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohamed Helmy, Resident doctor

Role: primary

+201018517954

Reda Badry, MD prof

Role: backup

+01008336450

References

Explore related publications, articles, or registry entries linked to this study.

Soares RL, Moreira-Filho PF, Maneschy CP, Breijao JF, Schmidte NM. The prevalence and clinical characteristics of primary headache in irritable bowel syndrome: a subgroup of the functional somatic syndromes. Arq Gastroenterol. 2013 Oct-Dec;50(4):281-4. doi: 10.1590/S0004-28032013000400008.

Reference Type BACKGROUND
PMID: 24474230 (View on PubMed)

Martami F, Ghorbani Z, Abolhasani M, Togha M, Meysamie A, Sharifi A, Razeghi Jahromi S. Comorbidity of gastrointestinal disorders, migraine, and tension-type headache: a cross-sectional study in Iran. Neurol Sci. 2018 Jan;39(1):63-70. doi: 10.1007/s10072-017-3141-0. Epub 2017 Oct 11.

Reference Type BACKGROUND
PMID: 29022143 (View on PubMed)

Doulberis M, Saleh C, Beyenburg S. Is there an Association between Migraine and Gastrointestinal Disorders? J Clin Neurol. 2017 Jul;13(3):215-226. doi: 10.3988/jcn.2017.13.3.215.

Reference Type BACKGROUND
PMID: 28748672 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Primary Headaches and IBS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IBS-C Questionnaire Study
NCT04968652 COMPLETED