Last reviewed · How we verify
NCT03557788
Changes in Microbiota and Metabolomic Profile Between Rifaximin Responders and Non-responders In Diarrhoea-Predominant Irritable Bowel Syndrome
Phase 4 trial testing Rifaximin Oral Tablet in Irritable Bowel Syndrome With Diarrhea in 33 participants. Completed in 13 August 2021.
13 August 2021
Quick facts
| Lead sponsor | National University Hospital, Singapore |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 33 |
| Start date | 7 May 2018 |
| Primary completion | 13 August 2021 |
| Estimated completion | 13 August 2021 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- Rifaximin Oral Tablet — full drug profile →
Conditions studied
- Irritable Bowel Syndrome With Diarrhea — all drugs for Irritable Bowel Syndrome With Diarrhea →
Sponsor
National University Hospital, Singapore
Who can join
Adults 21 to 65, any sex, with Irritable Bowel Syndrome With Diarrhea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Irritable Bowel Syndrome (IBS) carries a high prevalence worldwide and imposes substantial economic burden on patients, healthcare systems and society. In recent years, dysbiosis of the gut microbiota and bile acid (BA) malabsorption have been identified as putative pathophysiological mechanisms. Bile acid metabolism and gut microbiota are closely related. When patients with IBS-D were compared to healthy subjects, total levels of faecal BAs do not differ, but increased faecal primary BAs and reduced secondary BAs have been repeatedly observed in patients with IBS-D, suggesting abnormal BA deconjugation. Rifaximin, a non-absorbable antibiotic, has been shown in a recent meta-analysis to produce a therapeutic clinical gain compared to other treatment options for IBS, including placebo, paralleled by a high safety profile. It is also now known that changes in fecal microbiota have been observed in patients with IBS who have responded positively to Rifaximin. The relationship between microbiota changes, metabolomics changes after Rifaximin is unclear. There is emerging data to suggest duodenal dysbiosis as a putative pathophysiology, which in one study, clustered together with salivary microbiota than with fecal microbiota. However, the oral microbiome in patients with IBS has never been explored, which could possibly explain the downstream observations of duodenal and fecal dysbiosis. The investigators aim to assess the changes in metabolomic and microbiota profile after Rifaximin treatment, between responders and non-responders. The investigators will also explore the oral microbiome in IBS patients, and assess its relationship with fecal microbiome between responders and non-responders.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03557788
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other National University Hospital, Singapore trials
Trials by the same sponsor.
- NCT06027983 — Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors · Phase 1, PHASE2 · not yet recruiting
- NCT07460505 — Mandibular Advancement to Reduce Ventricular Load and Improve Quality-of-life in Heart Failure · NA · not yet recruiting
- NCT07319676 — Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas · Phase 1, PHASE2 · recruiting
- NCT06983769 — CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial · NA · recruiting
- NCT07091175 — Dupilumab Therapy in Nephrotic Syndrome in Children · Phase 2 · recruiting
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 NCT03557788 (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 National University Hospital, Singapore
- Last refreshed: 19 April 2022
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/NCT03557788.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing