Clinical trial NCT05057533: Primary Headaches and Irritable Bowel Syndrome.
Official title: Association Between Primary Headaches and Irritable Bowel Syndrome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Headache Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

Brief summary: To assess the relationship between primary headaches and irritable bowel syndrome

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Association between primary headaches and irritable bowel syndrome
timeFrame: Basline
Secondary outcomes:
measure: Subtypes of primary headachecs and IBS
timeFrame: Basline
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
Study officials:
name: Reda Badry, MD prof
role: STUDY_DIRECTOR
name: Wael Abbas
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: 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.