ClinicalTrials.gg
Status unknownNCT05057533Updated Sep 29, 2021

Primary Headaches and Irritable Bowel Syndrome.

An observational study in Primary Headache Disorder, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-29.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
197
Ages
18 Years and older
Sex
All
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Study summary

To assess the relationship between primary headaches and irritable bowel syndrome

Read the 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 .

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Conditions studied

  • Primary Headache Disorder
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In context

Headache Disorders, Primary

42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.

This study's planned enrollment of 197 is above the median of 120 across 21 observational studies indexed under Headache Disorders, Primary.

Browse Headache Disorders, Primary studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
197 participants (estimated)
Patient registry
No

Interventions

  • Othera 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.

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What researchers measure

Primary outcomes

  1. Association between primary headaches and irritable bowel syndrome

    To Detect the prevalence of IBS among patients with primary headaches

    Time frame: Basline

Secondary outcomes

  1. Subtypes of primary headachecs and IBS

    Detect the intimate correlation between each type of primary headaches and IBS

    Time frame: Basline

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 24474230 ↗
  • 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. PubMed 29022143 ↗
  • 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. PubMed 28748672 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2022; primary completion for Jan 2022, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2021
First posted
Sep 27, 2021
StartEst.
Jan 1, 2022
Primary completionEst.
Jan 1, 2022
CompletionEst.
Feb 1, 2022
Last update
Sep 29, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05057533
Lead sponsor
Assiut University
Responsible party
Mohamed Gamal Helmy (Resident doctor, Assiut University) — Principal investigator
First posted
Sep 27, 2021
Start date
Jan 1, 2022 (estimated)
Primary completion
Jan 1, 2022 (estimated)
Completion
Feb 1, 2022 (estimated)
Last update
Sep 29, 2021

Study contacts

Mohamed Helmy, Resident doctor
Contact
Mohamedgamahelmy@gmail.com
+201018517954
Wafaa Fargaly, MD prof
Contact
Wafmaf2002@yahoo.com
+201000104904
Reda Badry, MD prof
study director
Wael Abbas
study director

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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