NCT06489444

Brief Summary

Clinical data, fresh feces and intestinal mucosal tissues of patients with diarrheal IBS were collected. High performance liquid chromatography, immunohistochemistry and immunofluorescence were used to study the amino acid levels in feces of patients with IBS, the expression of taste receptors in intestinal mucosa, and the correlation between symptoms of abdominal pain and diarrhea and the expression of taste receptors, so as to obtain the conclusion that "intestinal amino acid perception abnormalities exist in patients with IBS. And correlated with clinical symptoms."

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 16, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

March 16, 2024

Last Update Submit

July 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Taste receptor expression was associated with symptom severity

    The severity of symptoms was correlated with the expression of taste receptors

    1 year

  • Association between fecal amino acid levels and symptom severity in patients

    The severity of symptoms was correlated with fecal amino acid

    1year

Study Arms (4)

IBS-D

IBS-C

Health control

UC(ulcerative colitis)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with irritable bowel syndrome who met all inclusion and exclusion criteria and corresponding healthy controls admitted to the gastroenterology Department of the Second Affiliated Hospital of Xi 'an Jiaotong University

You may qualify if:

  • Patients with IBS who meet the Rome IV diagnostic criteria:
  • that is, recurrent abdominal pain, with symptoms occurring at least 1 day per week or at least 3 days per month on average in the last 3 months, combining 2 or more of the following:
  • related to defecation;
  • accompanied by changes in the frequency of bowel movements;
  • Accompanied by changes in fecal characteristics (appearance). (Symptoms appeared at least 6 months before diagnosis, and above diagnostic criteria were met in the last 3 months) 2. Age ≥18 years old.

You may not qualify if:

  • \. History of celiac disease and other organic intestinal diseases, metabolic diseases (thyroid dysfunction, diabetes, etc.); (2) Serious neurological, mental and psychological diseases, or accompanied by serious organ dysfunction; 3. Abdominal surgery; 4. Pregnant, possible pregnant and lactating patients; 5. History of colonoscopy in the past 1 year; 6. Declined to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, 710004, China

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2024

First Posted

July 8, 2024

Study Start

March 16, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Locations