Constipation-predominant Irritable Bowel SyndromeNCT05921383
Anorectal Manometry of Patients With Constipation Predominant IBS
An observational study of Constipation-predominant Irritable Bowel Syndrome, run by Assiut University.
Trial summary
The aim of The study is to compare between the anorectal manometric profile of patients with functional constipation and patients with constipation predominant irritabe bowel syndrome Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Constipation-predominant Irritable Bowel Syndrome
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: both males and females between age 18-60 years
Who may be able to join
- Age between 18- 60 years old .
- Patients fulfill ROME IV criteria of chronic constipation.
Who cannot join
- Patient with secondary causes of constipation :-
- Thyroid disease
- Acute or chronic kidney disease
- Acute or Chronic Liver Disease.
- Malignancy 5 -Medication 6 -Uncontrolled diabetes mellitus 7 -Inflammatory bowel diseases
About this study
Official title: Anorectal Manometry of Patients With Constipation Predominant Irritable Bowel Syndrome
The aim of The study is to compare between the anorectal manometric profile of patients with functional constipation and patients with constipation predominant irritabe bowel syndrome
Read the detailed description
Chronic constipation (CC) is a common medical problem throughout the world [1-3] The global prevalence of CC in the community varies from 11% to 18% [4].
In patients presenting to tertiary care facilities, specific pathophysiological abnormalities like defecatory disorder and slow colonic transit contribute to CC.
CC has a significant burden on the utilization of healthcare resources, including the cost of inpatient and outpatient care, laboratory tests, and diagnostic procedures [5, 6].
CC is characterized by difficulty in passing stools or a low frequency of bowel movements, often accompanied by straining during defecation or a feeling of incomplete evacuation [7, 8].
For western population, CC is defined by Bristol stool form (BSF) I-II, while in Indian patients, addition of type III Bristol stool form increases diagnostic sensitivity [2]. In the ROME IV criteria, it has been suggested that all patients with CC without evidence of structural or metabolic abnormalities to explain symptoms should be considered under the umbrella of functional constipation (FC) [8].
FC is defined as the presence of two or more of the followings during the previous 3 months:
- Defecatory straining (> 25% of bowel movements)
- Hard or lumpy stools (> 25% of bowel movements)
- Feeling of incomplete evacuation (> 25% of bowel movements)
- Defecatory obstruction (> 25% of bowel movements)
- Manual maneuvers to facilitate defecation (> 25% of bowel movements)
- Fewer than three spontaneous complete bowel movements per week. Symptoms must be present for at least 6 months before the diagnosis, and diarrhea must not be present except after using a laxative [8].
Patients with FC should not meet irritable bowel syndrome (IBS) criteria, although bloating may be present. In contrast, patients with irritable bowel syndrome with constipation (IBS-C) have abdominal pain as the predominant symptom along with Bristol stool form types 1 or 2 more than 25% of the times. [8].
Among patients presenting with CC, Indian studies have reported FC to be commoner than IBS-C [9, 10-12].
High-resolution (HR-) anorectal manometry has significant diagnostic value in the assessment of anorectal disorders [13] This study aimed to compare the clinical and anorectal manometry profile of patients with FC and constipation-predominant irritable bowel syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of manometry for diagnosis of functional constipation
The aim of The study is to compare between the anorectal manometric profile of patients with functional constipation and patients with constipation predominant irritabe bowel syndrome
Measured: 1years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Constipation-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Sayed Zaki Bebe, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921383
- Sponsor's protocol ID
- Anorectal manometery
- Status last verified
- Jun 2023
- First submitted
- 18 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA. 2015 Mar 3;313(9):949-58. doi: 10.1001/jama.2015.0954.
PubMed 25734736
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anorectal Manometry of Patients With Constipation Predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05921383
- Acronym / sponsor ID
- Anorectal manometery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of The study is to compare between the anorectal manometric profile of patients with functional constipation and patients with constipation predominant irritabe bowel syndrome
Detailed description
Chronic constipation (CC) is a common medical problem throughout the world [1-3] The global prevalence of CC in the community varies from 11% to 18% [4].
In patients presenting to tertiary care facilities, specific pathophysiological abnormalities like defecatory disorder and slow colonic transit contribute to CC.
CC has a significant burden on the utilization of healthcare resources, including the cost of inpatient and outpatient care, laboratory tests, and diagnostic procedures [5, 6].
CC is characterized by difficulty in passing stools or a low frequency of bowel movements, often accompanied by straining during defecation or a feeling of incomplete evacuation [7, 8].
For western population, CC is defined by Bristol stool form (BSF) I-II, while in Indian patients, addition of type III Bristol stool form increases diagnostic sensitivity [2]. In the ROME IV criteria, it has been suggested that all patients with CC without evidence of structural or metabolic abnormalities to explain symptoms should be considered under the umbrella of functional constipation (FC) [8].
FC is defined as the presence of two or more of the followings during the previous 3 months:
- Defecatory straining (> 25% of bowel movements)
- Hard or lumpy stools (> 25% of bowel movements)
- Feeling of incomplete evacuation (> 25% of bowel movements)
- Defecatory obstruction (> 25% of bowel movements)
- Manual maneuvers to facilitate defecation (> 25% of bowel movements)
- Fewer than three spontaneous complete bowel movements per week. Symptoms must be present for at least 6 months before the diagnosis, and diarrhea must not be present except after using a laxative [8].
Patients with FC should not meet irritable bowel syndrome (IBS) criteria, although bloating may be present. In contrast, patients with irritable bowel syndrome with constipation (IBS-C) have abdominal pain as the predominant symptom along with Bristol stool form types 1 or 2 more than 25% of the times. [8].
Among patients presenting with CC, Indian studies have reported FC to be commoner than IBS-C [9, 10-12].
High-resolution (HR-) anorectal manometry has significant diagnostic value in the assessment of anorectal disorders [13] This study aimed to compare the clinical and anorectal manometry profile of patients with FC and constipation-predominant irritable bowel syndrome
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- both males and females between age 18-60 years
Key inclusion criteria (2 listed)
- Age between 18- 60 years old .
- Patients fulfill ROME IV criteria of chronic constipation.
Key exclusion criteria (5 listed)
- Patient with secondary causes of constipation :-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Value of manometry for diagnosis of functional constipation
Time frame: 1years
The aim of The study is to compare between the anorectal manometric profile of patients with functional constipation and patients with constipation predominant irritabe bowel syndrome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Results publication: PubMed 25734736Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA. 2015 Mar 3;313(9):949-58. doi: 10.1001/jama.2015.0954.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation-predominant Irritable Bowel Syndrome, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of manometry for diagnosis of functional constipation (time frame: 1years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05921383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.