Evidence types

Phase 2 clinical trial

Phase 2 clinical trial articles covering treatment signals, dosing, safety, and mid-stage IBD research.

Page 1 of 3 · 119 articles

2'-Fucosyllactose modulates gut microbiota and systemic metabolism in mild-to-moderate ulcerative colitis: a randomized crossover trial.
Journal of Crohn's & colitis

2'-Fucosyllactose modulates gut microbiota and systemic metabolism in mild-to-moderate ulcerative colitis: a randomized crossover trial.

The study suggests a dietary/prebiotic compound (2'-FL) can change gut microbes and patient-reported disease control in mild-to-moderate UC, which could point to non-drug ways to support symptoms and microbiome health.

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NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
ClinicalTrials.gov

NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease

People with Crohn's disease who develop symptomatic intestinal strictures currently often need endoscopic dilation or surgery. This trial tests an investigational oral drug (ontunisertib) aiming to improve...

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A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
ClinicalTrials.gov

A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis

A pediatric Phase 2 trial testing etrasimod could expand treatment options for children with moderately to severely active ulcerative colitis if later shown safe and effective. Families of affected children and their...

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A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
ClinicalTrials.gov

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy

The trial could show whether a smart-label app plus clinician alerts improves medication adherence and downstream clinical outcomes for people with Crohn's disease or ulcerative colitis starting oral or subcutaneous...

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A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

A new oral investigational therapy (TAK-279) is being tested in a randomized phase 2 trial for moderate–severe ulcerative colitis. Trial results could influence future treatment options if the drug proves safe and...

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Shifting Acute Severe Ulcerative Colitis Away from the Hospital: A Pilot Randomized Trial of Outpatient ASUC Management
NIH RePORTER

Shifting Acute Severe Ulcerative Colitis Away from the Hospital: A Pilot Randomized Trial of Outpatient ASUC Management

This pilot tests whether some patients with acute severe ulcerative colitis could avoid hospitalization by using early oral JAK inhibitor therapy plus steroids with close remote monitoring — a change that could reduce...

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VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
ClinicalTrials.gov

VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study

Patients and clinicians often want to know how quickly symptoms improve after starting a biologic. This study is designed to compare early patient‑reported symptom changes after starting vedolizumab versus IL‑23...

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Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
ClinicalTrials.gov

Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis

This registry will track how people with moderate to severe ulcerative colitis do on risankizumab in routine Japanese clinical practice, which may provide information about real-world remission rates and longer-term...

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A Study in Adults With Inflammatory Bowel Disease (IBD) Receiving Vedolizumab in the Patient Support Program (PSP) in Brazil
ClinicalTrials.gov

A Study in Adults With Inflammatory Bowel Disease (IBD) Receiving Vedolizumab in the Patient Support Program (PSP) in Brazil

Real-world PSP registries can show how long people stay on vedolizumab and how it’s used alongside or compared with other advanced therapies like tofacitinib. That information can help patients and clinicians understand...

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Emerging insights into TL1A biology may guide precision therapy for IBD.
The Journal of experimental medicine

Emerging insights into TL1A biology may guide precision therapy for IBD.

TL1A-blocking antibodies have shown promising response rates in early trials for both Crohn's disease and ulcerative colitis. Understanding TL1A biology could help match new therapies to the patients most likely to...

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A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

This registered Phase 2/3 program is evaluating guselkumab (an IL‑23 inhibitor) for moderate–severe Crohn's disease and could expand treatment options if trials show benefit and safety. The studies include clinical and...

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Modified Crohn's Disease Exclusion Diet and exclusive enteral nutrition (EEN) resolve oral dysbiosis in pediatric Crohn's disease: a prospective cohort study
PubMed Central

Modified Crohn's Disease Exclusion Diet and exclusive enteral nutrition (EEN) resolve oral dysbiosis in pediatric Crohn's disease: a prospective cohort study

The oral microbiome in children with Crohn's disease appears to reflect disease severity and changes with treatment, suggesting a potential noninvasive biomarker for monitoring response to nutritional therapies like CDED...

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A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

This registered Phase 2 trial tests guselkumab, golimumab, and a new investigational agent (JNJ-78934804) in adults with moderate–severe ulcerative colitis who previously failed advanced therapies. Results could affect...

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An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
ClinicalTrials.gov

An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

Long-term safety data on biologics and thiopurines are important for people with ulcerative colitis because they help patients and clinicians weigh risks (including malignancies and pregnancy-related outcomes) when...

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Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease
ClinicalTrials.gov

Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease

This trial tests whether pomegranate juice can lower fecal calprotectin, a commonly used marker of intestinal inflammation, in people with IBD in remission. If effective, such a dietary approach could be of interest to...

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STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP
ClinicalTrials.gov

STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP

The study tests whether adding MRI-based transmural assessment to a fecal-calprotectin–guided (CALM) strategy improves the ability to keep people with Crohn’s disease in corticosteroid-free clinical remission and may...

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