Irritable Bowel Syndrome - DiarrhoeaPhase 4NCT07061184
Fengliao Changweikang for Diarrhea-predominant Irritable Bowel Syndrome: N-of-1 Trial
A Phase 4 study testing FLCWK in people with Irritable Bowel Syndrome - Diarrhoea and Traditional Chinese Medicine (TCM), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Irritable bowel syndrome with diarrhea (IBS-D) is a functional gastrointestinal disorder, with characteristics of defecation related abdominal pain and diarrhea. Routine treatment strategy for IBS-D is symptom-based with unsatisfactory results, while there is a growing interest in complementary and alternative… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome - Diarrhoea, Traditional Chinese Medicine (TCM), N of 1 Study Design
- What is being tested?
- FLCWK
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Nov 2025to May 2028
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years.
- Mild to moderate IBS-D patients, with IBS Severity Scoring System (IBS-SSS) scores of 75 to 300 points[14].
- Ability to complete questionnaires and provide written informed consent.
- Current use of IBS medications (probiotics, antibiotics, antispasmodic, antidiarrheal and neuromodulators) should be prescribed on a stable dose at least 30 days prior to enrollment, and have no plan to change the dose, diet or lifestyle.
- Normal blood cell count, liver function, creatinine and urea levels within the last 2 weeks.
Who cannot join
- History of organic gastrointestinal diseases such as inflammatory bowel disease, celiac disease and malignancy.
- Scores of IBS-SSS > 300 points or IBS-SSS < 75 points.
- History of severe heart, kidney or liver diseases.
- Pregnant or breastfeeding.
- Current alcohol or drug abuse.
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Dong Wu, M.D., 8618612671010, dongwu@pumc.edu.cn
About this study
Official title: The Efficacy of Fengliao Changweikang Keli for Patients With Diarrhea-predominant Irritable Bowel Syndrome: Study Protocol for a Multicenter, Randomized, Placebo-controlled N-of-1 Trial
Irritable bowel syndrome with diarrhea (IBS-D) is a functional gastrointestinal disorder, with characteristics of defecation related abdominal pain and diarrhea. Routine treatment strategy for IBS-D is symptom-based with unsatisfactory results, while there is a growing interest in complementary and alternative medicine such as Traditional Chinese Medicine. However, lack of high-quality evidences being the obstacle for its development.
This study aims to evaluate the efficacy of Fengliao Changweikang Keli (FLCWK) on symptoms and health-related quality of life in mild to moderate IBS-D patients.
After 2-week run-in period, each participant will be randomized to a sequence of six 4-week double-blind treatment periods of FLCWK 8 g three times daily or placebo, separated by 2-week washout periods.
- Conditions
- Irritable Bowel Syndrome - Diarrhoea, Traditional Chinese Medicine (TCM), N of 1 Study Design, Efficacy and Safety
- Being tested
- FLCWK, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLCWKDrug
FLCWK and matching placebo to be taken in a randomised order for 9 months
PlaceboDrug
FLCWK and matching placebo to be taken in a randomised order for 9 months
| Study group | Role | What they receive |
|---|---|---|
| FLCWK | Experimental | FLCWK one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months Receives: Drug: FLCWK; Drug: Placebo |
| Placebo | Placebo comparator | Placebo one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months Receives: Drug: FLCWK; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-SSS score
The severity score questionnaire consists of 5 items and each item is rated on a scale of 0-100 points, leading to a total score of 0-500 points. An improvement of more than 50 points for IBS-SSS questionnaire is considered clinical effective.
Measured: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).
Secondary outcomes (2)
IBS-QOL score
IBS-QOL is a 34-item questionnaire assessing patient's health related quality of life, and higher scores indicate a better quality of life. IBS-QOL focuses on eight domains, namely dysphoria, activity interference, body image, health worry, food avoidance, social reaction, sexual and relationships, and an increase of more than 14 points indicates clinical improvement in quality of life. The minimal clinically important difference (MCID) on the IBS-QOL is defined as a change of 10 points in the total score.
Measured: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).
self-reported symptoms including abdominal pain and diarrhea
The score of worst abdominal pain in the past 24 hours will be evaluated by visual analogue scale (VAS) ranging from 0 to 10. The stool consistency of the past 24 hours will also be rated by BSFS, based on a 1 to 7 scale where 1 corresponds to a hard stool and 7 corresponds to watery diarrhea.
Measured: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome - DiarrhoeaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- N-of-1 trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DONG WU, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061184
- Sponsor's protocol ID
- I-25PJ1478
- Other IDs
- 2022YFC2504006
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Fengliao Changweikang Keli for Patients With Diarrhea-predominant Irritable Bowel Syndrome: Study Protocol for a Multicenter, Randomized, Placebo-controlled N-of-1 Trial
- ClinicalTrials.gov ID
- NCT07061184
- Acronym / sponsor ID
- I-25PJ1478
- Conditions
- Irritable Bowel Syndrome - Diarrhoea, Traditional Chinese Medicine (TCM), N of 1 Study Design, Efficacy and Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 11 Jul 2025 (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.
Irritable bowel syndrome with diarrhea (IBS-D) is a functional gastrointestinal disorder, with characteristics of defecation related abdominal pain and diarrhea. Routine treatment strategy for IBS-D is symptom-based with unsatisfactory results, while there is a growing interest in complementary and alternative medicine such as Traditional Chinese Medicine. However, lack of high-quality evidences being the obstacle for its development.
This study aims to evaluate the efficacy of Fengliao Changweikang Keli (FLCWK) on symptoms and health-related quality of life in mild to moderate IBS-D patients.
After 2-week run-in period, each participant will be randomized to a sequence of six 4-week double-blind treatment periods of FLCWK 8 g three times daily or placebo, separated by 2-week washout periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- N-of-1 trial
| Arm | Type | Receives |
|---|---|---|
| FLCWK | Experimental | Drug: FLCWK, Drug: PlaceboFLCWK one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months |
| Placebo | Placebo comparator | Drug: FLCWK, Drug: PlaceboPlacebo one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 75 years.
- Mild to moderate IBS-D patients, with IBS Severity Scoring System (IBS-SSS) scores of 75 to 300 points[14].
- Ability to complete questionnaires and provide written informed consent.
- Current use of IBS medications (probiotics, antibiotics, antispasmodic, antidiarrheal and neuromodulators) should be prescribed on a stable dose at least 30 days prior to enrollment, and have no plan to change the dose, diet or lifestyle.
- Normal blood cell count, liver function, creatinine and urea levels within the last 2 weeks.
Key exclusion criteria (5 listed)
- History of organic gastrointestinal diseases such as inflammatory bowel disease, celiac disease and malignancy.
- Scores of IBS-SSS > 300 points or IBS-SSS < 75 points.
- History of severe heart, kidney or liver diseases.
- Pregnant or breastfeeding.
- Current alcohol or drug abuse.
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 |
|---|---|---|
| FLCWKFLCWK and matching placebo to be taken in a randomised order for 9 months | Drug | FLCWK, Placebo |
| PlaceboFLCWK and matching placebo to be taken in a randomised order for 9 months | Drug | FLCWK, Placebo |
Primary outcome
IBS-SSS score
Time frame: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).
The severity score questionnaire consists of 5 items and each item is rated on a scale of 0-100 points, leading to a total score of 0-500 points. An improvement of more than 50 points for IBS-SSS questionnaire is considered clinical effective.
2 secondary outcomes
IBS-QOL score
Time frame: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).
self-reported symptoms including abdominal pain and diarrhea
Time frame: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).
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 11 Jul 2025.
- Individual participant dataSharing planned: No
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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 4 study testing FLCWK in people with Irritable Bowel Syndrome - Diarrhoea and Traditional Chinese Medicine (TCM), run by Peking Union Medical College Hospital 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 5 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: opening soon, as of the sponsor's last update on 11 Jul 2025. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Dong Wu, M.D. (8618612671010, dongwu@pumc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS-SSS score (time frame: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).). 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 11 Jul 2025.