Primary Headaches and Irritable Bowel Syndrome.

NCT05057533 | Unknown

• 1 other identifier: Primary Headaches and IBS
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the relationship between primary headaches and irritable bowel syndrome

Conditions

Primary Headache Disorder

Outcome Measures

Primary Outcomes (1)

• Association between primary headaches and irritable bowel syndrome

  To Detect the prevalence of IBS among patients with primary headaches

  Basline

Secondary Outcomes (1)

• Subtypes of primary headachecs and IBS

  Basline

Interventions

a questionnaire based on Rome IV Diagnostic criteria of IBS OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, Egypt

Location

Related Publications (3)

• 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.

  PMID: 24474230 BACKGROUND

• 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.

  PMID: 29022143 BACKGROUND

• 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.

  PMID: 28748672 BACKGROUND

MeSH Terms

Conditions

Headache Disorders, Primary

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Reda Badry, MD prof

  STUDY DIRECTOR

• Wael Abbas

  STUDY DIRECTOR

Central Study Contacts

Mohamed Helmy, Resident doctor

CONTACT

+201018517954; Mohamedgamahelmy@gmail.com

Wafaa Fargaly, MD prof

CONTACT

+201000104904; Wafmaf2002@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

EG (1)