IBS - Irritable Bowel SyndromePhase 4NCT04074421
Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D
A Phase 4 study testing Rifaximin and Probiotic Formula in people with IBS - Irritable Bowel Syndrome and Gut Microbiota, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
We will use the latest Rome IV criteria to recruit IBS-D patients and evaluate the effects of repeated treatment with rifaximin and sequential treatment with rifaximin and probiotics on different symptoms and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome, Gut Microbiota
- What is being tested?
- Rifaximin and Probiotic Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2020to Dec 2022
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old;
- in line with the diagnostic criteria of diarrhea-type irritable bowel syndrome Roman IV；
- blood routine, blood biochemistry, stool examination and colonoscopy within 2 years are no problem;
- no intestinal warning symptoms
Who cannot join
- suffering from severe heart, lung, liver, kidney, nervous system diseases;
- suffering from mental disorders caused by schizophrenia, brain organic and physical diseases;
- suffering from other diseases that may affect intestinal function (such as diabetes, thyroid disease);
- History of previous abdominal surgery (excluding history of cholecystectomy or appendectomy);
- pregnant or lactating women;
- have undergone colonoscopy in the past month or accept other bowel preparation operations;
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- In the past 1 month, have used antibiotics, antidiarrheal agents, intestinal flora regulation, Chinese medicine and other drugs;
- have participated in other dietary treatments;
- understand communication barriers, unable to communicate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Jian-an The President
About this study
Official title: Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With Diarrhoea-predominant Irritable Bowel syndrome-a Multicentre Controlled Study
We will use the latest Rome IV criteria to recruit IBS-D patients and evaluate the effects of repeated treatment with rifaximin and sequential treatment with rifaximin and probiotics on different symptoms and quality of life. High-throughput sequencing combined with real-time quantitative PCR will be used to comprehensively analyze the effects of different drugs on intestinal flora. The study has important guiding significance for the treatment of patients with IBS-D.
Read the detailed description
According to the Rome IV diagnostic criteria, 200 patients with with diarrhoea-predominant irritable bowel syndrome (IBS-D) from the multi-center (8 units in the country) will be enrolled. The IBS Severity Inventory (IBS-SSS) and IBS Quality of Life Scores (QOL) will be used to evaluate the effect of treatments. Retreatment patients who are initially treated and not satisfied with the improvement of symptoms and quality of life will be treated with Rifaximin for 2 weeks. Fecal specimens will be collected from patients who responded to treatment, and the fecal bacteria will be analyzed by real-time polymerase chain reaction (PCR) using 16 S ribosomal ribonucleic acid (rRNA) gene. Patients who responded to Rifaximin treatment will be randomized into A (Probiotics group) and B (Placebo group). IBS symptom grade score and quality of life score will be evaluated before and after treatment, and fecal specimens of the responding patients will be collected for intestinal probiotics and harmful bacteria detection.
- Conditions
- IBS - Irritable Bowel Syndrome, Gut Microbiota
- Being tested
- Rifaximin, Probiotic Formula, Placebo oral tablet
- Keywords
- Rifaximin, Probiotics, IBS-D, gut microbiota
- 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.
RifaximinDrug
A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
Probiotic FormulaDrug
Also called probiotic formula Bacillus subtilis and Enterococcus faecium
A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.
Placebo oral tabletDrug
Also called Placebo
Placebo oral tablet that has no therapeutic effect
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin group | Active comparator | Repeating treatment of Rifaximin Receives: Drug: Rifaximin |
| Probiotics group | Sham comparator | Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium Receives: Drug: Probiotic Formula |
| Placebo group | Placebo comparator | Placebo control group Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the IBS symptom grade score
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
Measured: baseline
the quality of life score
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
Measured: baseline
the IBS symptom grade score
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
Measured: 2 weeks
the quality of life score
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
Measured: 2 weeks
the IBS symptom grade score
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
Measured: 12 weeks
the quality of life score
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
Measured: 12 weeks
16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
Measured: 12 weeks
16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
Measured: baseline
16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start10 May 2020
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, RenJi Hospital, Peking Union Medical College Hospital, First Affiliated Hospital of Wenzhou Medical University, The Central Hospital of Lishui City
- Responsible party
- Sponsor
- Investigators
- Liangjing Wang, Ph.D, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074421
- Sponsor's protocol ID
- (2019) Study No. 413
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is not yet recruiting and unfinished.
Publications
Zhong J, Xu Z, Chen W, Jiang Y, Ge Q, Deng Y, He W, Mao X, Zhu Y, Sang J, Zheng P, Yao L, Han F, You H, Chen S, Wang L. Consolidation Therapy of Probiotics With Rifaximin Prevent Relapse in Rifaximin-Responsive Diarrhea-Predominant Irritable Bowel Syndrome: A Multicenter Randomized Clinical Trial. J Gastroenterol Hepatol. 2026 Aug 18. doi: 10.1111/jgh.70672. Online ahead of print.
PubMed 42609157
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With Diarrhoea-predominant Irritable Bowel syndrome-a Multicentre Controlled Study
- ClinicalTrials.gov ID
- NCT04074421
- Acronym / sponsor ID
- (2019) Study No. 413
- Conditions
- IBS - Irritable Bowel Syndrome, Gut Microbiota
- Keywords
- Rifaximin, Probiotics, IBS-D, gut microbiota
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, RenJi Hospital, Peking Union Medical College Hospital, First Affiliated Hospital of Wenzhou Medical University, The Central Hospital of Lishui City
- Study start
- 10 May 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Aug 2019 (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.
We will use the latest Rome IV criteria to recruit IBS-D patients and evaluate the effects of repeated treatment with rifaximin and sequential treatment with rifaximin and probiotics on different symptoms and quality of life. High-throughput sequencing combined with real-time quantitative PCR will be used to comprehensively analyze the effects of different drugs on intestinal flora. The study has important guiding significance for the treatment of patients with IBS-D.
Detailed description
According to the Rome IV diagnostic criteria, 200 patients with with diarrhoea-predominant irritable bowel syndrome (IBS-D) from the multi-center (8 units in the country) will be enrolled. The IBS Severity Inventory (IBS-SSS) and IBS Quality of Life Scores (QOL) will be used to evaluate the effect of treatments. Retreatment patients who are initially treated and not satisfied with the improvement of symptoms and quality of life will be treated with Rifaximin for 2 weeks. Fecal specimens will be collected from patients who responded to treatment, and the fecal bacteria will be analyzed by real-time polymerase chain reaction (PCR) using 16 S ribosomal ribonucleic acid (rRNA) gene. Patients who responded to Rifaximin treatment will be randomized into A (Probiotics group) and B (Placebo group). IBS symptom grade score and quality of life score will be evaluated before and after treatment, and fecal specimens of the responding patients will be collected for intestinal probiotics and harmful bacteria detection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rifaximin group | Active comparator | Drug: RifaximinRepeating treatment of Rifaximin |
| Probiotics group | Sham comparator | Drug: Probiotic FormulaSequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium |
| Placebo group | Placebo comparator | Drug: Placebo oral tabletPlacebo control group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years old;
- in line with the diagnostic criteria of diarrhea-type irritable bowel syndrome Roman IV；
- blood routine, blood biochemistry, stool examination and colonoscopy within 2 years are no problem;
- no intestinal warning symptoms
Key exclusion criteria (9 listed)
- suffering from severe heart, lung, liver, kidney, nervous system diseases;
- suffering from mental disorders caused by schizophrenia, brain organic and physical diseases;
- suffering from other diseases that may affect intestinal function (such as diabetes, thyroid disease);
- History of previous abdominal surgery (excluding history of cholecystectomy or appendectomy);
- 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 |
|---|---|---|
| RifaximinA non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks. | Drug | Rifaximin group |
| Probiotic FormulaAlso: probiotic formula Bacillus subtilis and Enterococcus faeciumA probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks. | Drug | Probiotics group |
| Placebo oral tabletAlso: PlaceboPlacebo oral tablet that has no therapeutic effect | Drug | Placebo group |
Primary outcome
the IBS symptom grade score
Time frame: baseline
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
the quality of life score
Time frame: baseline
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
the IBS symptom grade score
Time frame: 2 weeks
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
the quality of life score
Time frame: 2 weeks
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
the IBS symptom grade score
Time frame: 12 weeks
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
the quality of life score
Time frame: 12 weeks
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
Time frame: 12 weeks
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
Time frame: baseline
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
Time frame: 2 weeks
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Derived from this study: PubMed 42609157Zhong J, Xu Z, Chen W, Jiang Y, Ge Q, Deng Y, He W, Mao X, Zhu Y, Sang J, Zheng P, Yao L, Han F, You H, Chen S, Wang L. Consolidation Therapy of Probiotics With Rifaximin Prevent Relapse in Rifaximin-Responsive Diarrhea-Predominant Irritable Bowel Syndrome: A Multicenter Randomized Clinical Trial. J Gastroenterol Hepatol. 2026 Aug 18. doi: 10.1111/jgh.70672. Online ahead of print.
- Individual participant dataSharing planned: No. The study is not yet recruiting and unfinished.
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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.
Liangjing Wang, Ph.D principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Rifaximin and Probiotic Formula in people with IBS - Irritable Bowel Syndrome and Gut Microbiota, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 9 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 28 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liangjing Wang, Ph.D (+8613777848083, wangljzju@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the IBS symptom grade score (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04074421, which also lists 1 linked publication.
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 28 Jul 2020.