RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: RO for Crohn Disease and Ulcerative Colitis

Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, is a chronic relapsing intestinal disorder driven by immune dysregulation, impaired mucosal barrier function, and gut microbiome dysbiosis. Although current therapies can control inflammation, many patients still experience recurrent symptoms, treatment resistance, adverse effects, and impaired quality of life.

Official registry: https://clinicaltrials.gov/study/NCT07799428 · Anabio R&D · enrollment listed as 150

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are RO, LiveSpo® DIA30, or LiveSpo® COLON. The registry lists allocation as randomized. Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, is a chronic relapsing intestinal disorder driven by immune dysregulation, impaired mucosal barrier function, and gut microbiome dysbiosis.

They plan to enroll about 150 people at Hà Nội. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Evaluating the Efficacy of Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease (IBD): An Interventional Trial

Interventions: RO, LiveSpo® DIA30, LiveSpo® COLON

Primary outcome (registry wording): Change in IBD-related quality of life

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
Age 18 to 65 years
Confirmed diagnosis of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, according to the routine diagnostic procedures of Hanoi Medical University Hospital
Receiving examination and treatment at Hanoi Medical University Hospital (including both inpatients and outpatients), with a minimum treatment or follow-up duration of 14 days

Who the registry excludes

Refusal to participate in the study
Withdrawal from the study before completing 14 days of treatment
Inability to comply with study procedures or inability to ensure adherence to the investigational product, as assessed by the investigator
Moderate to severe hepatic or renal dysfunction, or other moderate to severe chronic cardiovascular, pulmonary, hepatic, or renal diseases that may affect general health status or require specialist treatment
Presence of immune-related diseases
Current use, or use within 4 weeks prior to screening, of biologic immunosuppressive therapies (for example, anti-TNF-α agents or vedolizumab)

Public study contact (from the registry)

Anh N Tran, Assoc.Prof.

(84)904831512

anhtn69@yahoo.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Department of Gastroenterology — Hà Nội, Vietnam (recruiting)

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FAQ about this NCT record

Is NCT07799428 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07799428?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07799428?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary