- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06489444
Fecal Amino Acids,Gut Taste Receptors and Irritable Bowel Syndromes
July 2, 2024 updated by: Second Affiliated Hospital of Xi'an Jiaotong University
Alterations in Nutrient-sensing Mechanisms May Play a Role in Symptom Generation in Patients With IBS
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."
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: wang jinhai
- Phone Number: 13609281113
- Email: jinhaiwang@hotmail.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710004
- Recruiting
- The Second Affiliated Hospital of Xi'an Jiaotong University
-
Contact:
- Jinhai Wang, MD
- Phone Number: +86-29-13609281113
- Email: jinhaiwang@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-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
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 1. 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
IBS-D
|
|
IBS-C
|
|
Health control
|
|
UC(ulcerative colitis)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Taste receptor expression was associated with symptom severity
Time Frame: 1 year
|
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
Time Frame: 1year
|
The severity of symptoms was correlated with fecal amino acid
|
1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 16, 2023
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
March 16, 2024
First Submitted That Met QC Criteria
July 2, 2024
First Posted (Actual)
July 8, 2024
Study Record Updates
Last Update Posted (Actual)
July 8, 2024
Last Update Submitted That Met QC Criteria
July 2, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023232
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.