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Not yet recruitingNCT05921383Updated Jun 27, 2023

Anorectal Manometry of Patients With Constipation Predominant IBS

An observational study in Constipation-predominant Irritable Bowel Syndrome, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-06-27.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
102
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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:

  1. Defecatory straining (> 25% of bowel movements)
  2. Hard or lumpy stools (> 25% of bowel movements)
  3. Feeling of incomplete evacuation (> 25% of bowel movements)
  4. Defecatory obstruction (> 25% of bowel movements)
  5. Manual maneuvers to facilitate defecation (> 25% of bowel movements)
  6. 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

02

Conditions studied

  • Constipation-predominant Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's planned enrollment of 102 is below the median of 150 across 178 observational studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

both males and females between age 18-60 years

Inclusion criteria

  1. Age between 18- 60 years old .
  2. Patients fulfill ROME IV criteria of chronic constipation.

Exclusion criteria

Exclusion Criteria:

  • Patient with secondary causes of constipation :-

    1. Thyroid disease
    2. Acute or chronic kidney disease
    3. Acute or Chronic Liver Disease.
    4. Malignancy 5 -Medication 6 -Uncontrolled diabetes mellitus 7 -Inflammatory bowel diseases
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
102 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1years

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05921383
Lead sponsor
Assiut University
Responsible party
Heba Sayed Zaki Bebe (resident doctor, Assiut University) — Principal investigator
First posted
Jun 27, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Nov 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jun 27, 2023

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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