Irritable Bowel SyndromeNCT06489444
Fecal Amino Acids，Gut Taste Receptors and Irritable Bowel Syndromes
An observational study of Irritable Bowel Syndrome, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2023to Aug 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of xi'an jiaotong university
Xi'an, Shaanxi, 710004
Jinhai Wang, MD, +86-29-13609281113, jinhaiwang@hotmail.com
About this study
Official title: 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."
- Conditions
- Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBS-D | Not described | |
| IBS-C | Not described | |
| Health control | Not described | |
| UC(ulcerative colitis) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste receptor expression was associated with symptom severity
The severity of symptoms was correlated with the expression of taste receptors
Measured: 1 year
Association between fecal amino acid levels and symptom severity in patients
The severity of symptoms was correlated with fecal amino acid
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start16 Mar 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489444
- Sponsor's protocol ID
- 2023232
- Status last verified
- Jul 2024
- First submitted
- 16 Mar 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Nutrient-sensing Mechanisms May Play a Role in Symptom Generation in Patients With IBS
- ClinicalTrials.gov ID
- NCT06489444
- Acronym / sponsor ID
- 2023232
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 8 Jul 2024 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IBS-D | – | – |
| IBS-C | – | – |
| Health control | – | – |
| UC(ulcerative colitis) | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Patients with IBS who meet the Rome IV diagnostic criteria:
Key exclusion criteria (1 listed)
- 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.
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
Taste receptor expression was associated with symptom severity
Time frame: 1 year
The severity of symptoms was correlated with the expression of taste receptors
Association between fecal amino acid levels and symptom severity in patients
Time frame: 1year
The severity of symptoms was correlated with fecal amino acid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
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 5 inclusion and 1 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact wang jinhai (13609281113, jinhaiwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste receptor expression was associated with symptom severity (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2024.