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NCT06612411
B.Subtilis Attenuate Symptoms in Diarrhea-predominant Irritable Bowel Syndrome by Increasing Hypoxanthine Biosynthesis
EARLY_PHASE1 trial testing B. subtilis in Irritable Bowel Syndrome with Diarrhea in 180 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | Jinling Hospital, China |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 1 June 2024 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 2 locations across China |
Drugs / interventions tested
- B. subtilis — full drug profile →
- Dead B. subtilis — full drug profile →
Conditions studied
- Irritable Bowel Syndrome with Diarrhea — all drugs for Irritable Bowel Syndrome with Diarrhea →
- Purine Metabolism Disorder — all drugs for Purine Metabolism Disorder →
Sponsor
Jinling Hospital, China
Who can join
Adults 16 to 80, any sex, with Irritable Bowel Syndrome with Diarrhea or Purine Metabolism Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06612411
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Jinling Hospital, China trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06612411 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jinling Hospital, China
- Last refreshed: 25 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06612411.
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