Irritable Bowel Syndrome with DiarrheaEarly Phase 1NCT06612411
B.Subtilis Attenuate Symptoms in Diarrhea-predominant Irritable Bowel Syndrome by Increasing Hypoxanthine Biosynthesis
A Early Phase 1 study testing B. subtilis and Dead B. subtilis in people with Irritable Bowel Syndrome with Diarrhea and Purine Metabolism Disorder, run by Jinling Hospital, China at 2 sites in China.
Trial summary
This is a prospective, single-blind, randomized parallel study to investigate whether B. subtilis could improve clinical symptoms of IBS-D patients. Patients are randomly assigned by envelope method. A senior gastroenterologist is responsible for prescribing medication. Researchers are blind to patients' medication. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome with Diarrhea, Purine Metabolism Disorder
- What is being tested?
- B. subtilis and Dead B. subtilis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2024to 31 Dec 2024
- Phase
- Early Phase 1
- 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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients are diagnosed with IBS. IBS was diagnosed based on the Rome IV criteria. Subjects aged from 16-80 years old without any gut medical conditions like inflammatory bowel diseases, infectious diarrhea, colon tumors were included.
Who cannot join
- Subjects who are taking any probiotics, PPIs, antibiotics or any drugs affecting uric acid levels for at least one month before the study.
- Subjects who decline to participate into the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Jinling Hospital
Nanjing
Fangyu Wang, 02586800051, wangfy65@nju.edu.cn
Hui Tao, 02580860114, xhnk51@126.com
- Recruiting
Jinling Hospital
Nanjing
Fangyu Wang, 025-80860051, wangfy65@nju.edu.cn
Hui Tao, 025-80860114, xhnk51@126.com
About this study
Official title: Purine Starvation Driven by Host-microbiota Maladaptation Contributes to the Pathogenesis of Irritable Bowel Syndrome
This is a prospective, single-blind, randomized parallel study to investigate whether B. subtilis could improve clinical symptoms of IBS-D patients. Patients are randomly assigned by envelope method. A senior gastroenterologist is responsible for prescribing medication. Researchers are blind to patients' medication. Participants with IBS are recruited and randomized to receive a 4-week administration of B. subtilis-based probiotics. Clinical symptoms and stool samples are collected before and after the trial.
- Being tested
- B. subtilis, Dead B. subtilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. subtilisDrug
Also called Medilac-s, S20030087, Beijing Hanmi Pharm.co.,Ltd
2 capsules, 3 times a day, orally taken for one month
Dead B. subtilisDrug
Also called Medilac-s, S20030087, Beijing Hanmi Pharm.co.,Ltd
2 capsules, 3 times a day, orally taken for one month
| Study group | Role | What they receive |
|---|---|---|
| B. subtilis intervention | Active comparator | Not described Receives: Drug: B. subtilis |
| Placebo capsules | Placebo comparator | Not described Receives: Drug: Dead B. subtilis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score of IBS-SSS before and after intervention
Measured: 6 months
Secondary outcomes (1)
The concentration of purine in the stool before and after intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 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 Syndrome with DiarrheaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fangyu Wang, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612411
- Sponsor's protocol ID
- No.2023DZKY-023-01
- Status last verified
- Sep 2024
- First submitted
- 12 Aug 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Purine Starvation Driven by Host-microbiota Maladaptation Contributes to the Pathogenesis of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06612411
- Acronym / sponsor ID
- No.2023DZKY-023-01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Sep 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.
This is a prospective, single-blind, randomized parallel study to investigate whether B. subtilis could improve clinical symptoms of IBS-D patients. Patients are randomly assigned by envelope method. A senior gastroenterologist is responsible for prescribing medication. Researchers are blind to patients' medication. Participants with IBS are recruited and randomized to receive a 4-week administration of B. subtilis-based probiotics. Clinical symptoms and stool samples are collected before and after the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B. subtilis intervention | Active comparator | Drug: B. subtilis |
| Placebo capsules | Placebo comparator | Drug: Dead B. subtilis |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients are diagnosed with IBS. IBS was diagnosed based on the Rome IV criteria. Subjects aged from 16-80 years old without any gut medical conditions like inflammatory bowel diseases, infectious diarrhea, colon tumors were included.
Key exclusion criteria (2 listed)
- Subjects who are taking any probiotics, PPIs, antibiotics or any drugs affecting uric acid levels for at least one month before the study.
- Subjects who decline to participate into 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B. subtilisAlso: Medilac-s, S20030087, Beijing Hanmi Pharm.co.,Ltd2 capsules, 3 times a day, orally taken for one month | Drug | B. subtilis intervention |
| Dead B. subtilisAlso: Medilac-s, S20030087, Beijing Hanmi Pharm.co.,Ltd2 capsules, 3 times a day, orally taken for one month | Drug | Placebo capsules |
Primary outcome
The score of IBS-SSS before and after intervention
Time frame: 6 months
1 secondary outcome
The concentration of purine in the stool before and after intervention
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: Yes
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Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
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Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing B. subtilis and Dead B. subtilis in people with Irritable Bowel Syndrome with Diarrhea and Purine Metabolism Disorder, run by Jinling Hospital, China at 2 sites 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 1 inclusion and 2 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 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of IBS-SSS before and after intervention (time frame: 6 months). 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 25 Sep 2024.