Diarrhea-predominant Irritable Bowel SyndromePhase 1NCT06737666
Study on the Effectiveness and Mechanism of Tong-Xie-Yao-Fang in Treating Diarrhea-predominant Irritable Bowel Syndrome
A Phase 1 study testing Tong-Xie-Yao-Fang in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Traditional Chinese Medicine focuses on the main pathogenesis of liver depression and spleen deficiency, and treats them from the perspective of soothing the liver and strengthening the spleen to treat on Diarrhea-predominant irritable bowel syndrome (IBS-D) . Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea-predominant Irritable Bowel Syndrome
- What is being tested?
- Tong-Xie-Yao-Fang
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2023to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- IBS-D patients and healthy volunteers meeting diagnostic criteria;
- Aged between 18 and 70;
- Have not taken antibiotics, steroids and other hormones, Chinese herbal preparations (including oral and intravenous injections), microecological preparations or probiotics such as yogurt in the past week.
- Patients sign informed consent forms and are willing to receive appropriate treatment, and volunteers are willing to cooperate in taking blood, urine, stool and other samples.
Who cannot join
- Patients with serious heart, liver, kidney and other major organ diseases, hematopoietic system, nervous system or mental diseases;
- Other organic diseases of the digestive system (such as peptic ulcers), organic diseases such as tumors indicated by recent colonoscopy, or systemic diseases affecting digestive motility (such as hyperthyroidism, diabetes);
- Need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anti-anxiety drugs, intestinal flora regulation drugs, antibiotics, etc.);
- Have a history of drug allergy or severe food allergy for research purposes;
- Patients under 18 years of age or over 75 years of age and pregnant or lactating women;
- Severe negative life events occurred during treatment;
- There is currently any form of psychotherapy in progress;
- No intention to cooperate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
Fengyun Wang, professor, +86(010)62835610, wfy811@163.com
About this study
Official title: Effects of Tong-Xie-Yao-Fang in Regulating Treg/Th17 Imbalance of Diarrhea-predominant Irritable Bowel Syndrome by Trp-Kyn-AhR Pathway
Traditional Chinese Medicine focuses on the main pathogenesis of liver depression and spleen deficiency, and treats them from the perspective of soothing the liver and strengthening the spleen to treat on Diarrhea-predominant irritable bowel syndrome (IBS-D) . The classic formula for treating is the Tong-Xie-Yao-Fang (TXYF). Based on metabolomics and metagenomics, the research group studied the intestinal flora and host co metabolism of TXYF in the treatment of diarrhea predominant IBS-D, in order to clarify the mechanism of TXYF in the treatment of IBS-D.
Read the detailed description
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common clinical functional gastrointestinal disease with unclear mechanism, which is mostly induced by emotion. There is no specific treatment for this disease. Traditional Chinese Medicine focuses on the main pathogenesis of liver depression and spleen deficiency, and treats them from the perspective of soothing the liver and strengthening the spleen. The classic formula for treating is the Tong-Xie-Yao-Fang (TXYF).Previous studies of our research group have shown that TXYF can significantly improve the symptoms of abdominal pain and diarrhea in patients with IBS-D, and improve the quality of life of patients. The effectiveness and safety of TXYF in the treatment of IBS-D have been evaluated, and its mechanism of action has also been explored.Modern studies have shown that changes in the local immune microenvironment can affect intestinal immunity and neuroregulation, mucosal barrier damage and abnormal co-metabolism of flora and host, which may be important reasons for the occurrence and development of IBS-D, but the detailed mechanism is unclear.Therefore, based on metabolomics and metagenomics, the research group studied the intestinal flora and host co metabolism of TXYF in the treatment of diarrhea predominant IBS-D, in order to clarify the mechanism of TXYF in the treatment of IBS-D.
- Being tested
- Tong-Xie-Yao-Fang
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tong-Xie-Yao-FangDrug
Tong-Xie-Yao-Fang granules were taken 2 bags at a time, 2 times per day at 1h after meal for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tong-Xie-Yao-Fang intervention group | Experimental | Not described Receives: Drug: Tong-Xie-Yao-Fang |
| healthy people | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal metagenomic detection of bacteria associated with Trp metabolism
Measured: 16weeks
Serum detection by Elisa
Measured: 16weeks
Serum Trp metabolism was measured by metabolomics
Measured: 16weeks
Th17/Treg ratio in peripheral blood was measured by flow cytometry
Measured: 16weeks
Colon tissue was detected by immunofluorescence and histochemistry analysis
Foxp3 ,RORrt ,AhR ,IDO1 ,Tyn
Measured: 16weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start29 May 2023
- Primary completion8 Oct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea-predominant 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737666
- Sponsor's protocol ID
- 2022XLA162-3
- Status last verified
- Dec 2024
- First submitted
- 28 Sep 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tong-Xie-Yao-Fang in Regulating Treg/Th17 Imbalance of Diarrhea-predominant Irritable Bowel Syndrome by Trp-Kyn-AhR Pathway
- ClinicalTrials.gov ID
- NCT06737666
- Acronym / sponsor ID
- 2022XLA162-3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 8 Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Dec 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.
Traditional Chinese Medicine focuses on the main pathogenesis of liver depression and spleen deficiency, and treats them from the perspective of soothing the liver and strengthening the spleen to treat on Diarrhea-predominant irritable bowel syndrome (IBS-D) . The classic formula for treating is the Tong-Xie-Yao-Fang (TXYF). Based on metabolomics and metagenomics, the research group studied the intestinal flora and host co metabolism of TXYF in the treatment of diarrhea predominant IBS-D, in order to clarify the mechanism of TXYF in the treatment of IBS-D.
Detailed description
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common clinical functional gastrointestinal disease with unclear mechanism, which is mostly induced by emotion. There is no specific treatment for this disease. Traditional Chinese Medicine focuses on the main pathogenesis of liver depression and spleen deficiency, and treats them from the perspective of soothing the liver and strengthening the spleen. The classic formula for treating is the Tong-Xie-Yao-Fang (TXYF).Previous studies of our research group have shown that TXYF can significantly improve the symptoms of abdominal pain and diarrhea in patients with IBS-D, and improve the quality of life of patients. The effectiveness and safety of TXYF in the treatment of IBS-D have been evaluated, and its mechanism of action has also been explored.Modern studies have shown that changes in the local immune microenvironment can affect intestinal immunity and neuroregulation, mucosal barrier damage and abnormal co-metabolism of flora and host, which may be important reasons for the occurrence and development of IBS-D, but the detailed mechanism is unclear.Therefore, based on metabolomics and metagenomics, the research group studied the intestinal flora and host co metabolism of TXYF in the treatment of diarrhea predominant IBS-D, in order to clarify the mechanism of TXYF in the treatment of IBS-D.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tong-Xie-Yao-Fang intervention group | Experimental | Drug: Tong-Xie-Yao-Fang |
| healthy people | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- IBS-D patients and healthy volunteers meeting diagnostic criteria;
- Aged between 18 and 70;
- Have not taken antibiotics, steroids and other hormones, Chinese herbal preparations (including oral and intravenous injections), microecological preparations or probiotics such as yogurt in the past week.
- Patients sign informed consent forms and are willing to receive appropriate treatment, and volunteers are willing to cooperate in taking blood, urine, stool and other samples.
Key exclusion criteria (8 listed)
- Patients with serious heart, liver, kidney and other major organ diseases, hematopoietic system, nervous system or mental diseases;
- Other organic diseases of the digestive system (such as peptic ulcers), organic diseases such as tumors indicated by recent colonoscopy, or systemic diseases affecting digestive motility (such as hyperthyroidism, diabetes);
- Need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anti-anxiety drugs, intestinal flora regulation drugs, antibiotics, etc.);
- Have a history of drug allergy or severe food allergy for research purposes;
- Patients under 18 years of age or over 75 years of age and pregnant or lactating women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tong-Xie-Yao-FangTong-Xie-Yao-Fang granules were taken 2 bags at a time, 2 times per day at 1h after meal for 4 weeks. | Drug | Tong-Xie-Yao-Fang intervention group |
Primary outcome
Fecal metagenomic detection of bacteria associated with Trp metabolism
Time frame: 16weeks
Serum detection by Elisa
Time frame: 16weeks
Serum Trp metabolism was measured by metabolomics
Time frame: 16weeks
Th17/Treg ratio in peripheral blood was measured by flow cytometry
Time frame: 16weeks
Colon tissue was detected by immunofluorescence and histochemistry analysis
Time frame: 16weeks
Foxp3 ,RORrt ,AhR ,IDO1 ,Tyn
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tong-Xie-Yao-Fang in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Dec 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fengyun Wang, professor (+86 (010)-62835610, wfy811@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal metagenomic detection of bacteria associated with Trp metabolism (time frame: 16weeks). The study lists 5 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 17 Dec 2024.