Primary Headaches and Irritable Bowel Syndrome.

Primary Headache Disorder Clinical Trial

Official title:

Association Between Primary Headaches and Irritable Bowel Syndrome.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05057533
• Other study ID #: Primary Headaches and IBS
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: February 1, 2022

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: Mohamed Helmy, Resident doctor
• Phone: +201018517954
• Email: Mohamedgamahelmy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the relationship between primary headaches and irritable bowel syndrome

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 197
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Irritable Bowel Syndrome
• Primary Headache Disorder

Intervention

Other:
• 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 Related to defecation (may be increased or unchanged by defecation) Associated with a change in stool frequency 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.

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

Soares RL, Moreira-Filho PF, Maneschy CP, Breijão 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between primary headaches and irritable bowel syndrome	To Detect the prevalence of IBS among patients with primary headaches	Basline
Secondary	Subtypes of primary headachecs and IBS	Detect the intimate correlation between each type of primary headaches and IBS	Basline