Evidence types

Clinical Trial Phase 1

Phase 1 clinical trial articles covering early human safety, dosing, and first-in-human treatment research relevant to IBD.

Page 1 of 2 · 60 articles

Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures
ClinicalTrials.gov

Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures

Researchers are testing whether baseline fecal microbiome profiles can predict who with mild ulcerative colitis will benefit from a specific prebiotic supplement. If validated, this approach could move dietary therapy...

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An Open-Label, Comparative, Parallel Clinical Trial of the Safety, Pharmacokinetics and Immunogenicity of the Ustekinumab Biosimilar GNR-068 and the Originally Developed Ustekinumab as a Reference Drug After a Single Subcutaneous Administration in Healthy Male Volunteers
Antibodies

An Open-Label, Comparative, Parallel Clinical Trial of the Safety, Pharmacokinetics and Immunogenicity of the Ustekinumab Biosimilar GNR-068 and the Originally Developed Ustekinumab as a Reference Drug After a Single Subcutaneous Administration in Healthy Male Volunteers

Ustekinumab treats Crohn’s disease and ulcerative colitis; a biosimilar that shows similar pharmacokinetics and safety could expand treatment options and affect availability and cost.

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Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation
ClinicalTrials.gov

Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation

People with an ileal pouch after UC/IBDU often struggle with fecal incontinence and reduced quality of life. This trial is testing a noninvasive device (Emsella chair) aimed at improving incontinence and patient-reported...

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Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis
ClinicalTrials.gov

Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis

Pouchitis is a common complication after IPAA and noninvasive tools to detect inflammation could make monitoring easier and less burdensome than repeated pouchoscopy. This trial tested whether intestinal ultrasound can...

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Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
ClinicalTrials.gov

Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy

Patients on anti-TNF biologics often seek safe ways to support gut microbial health. This trial tests a prebiotic supplement (2'-FL) for safety and whether it increases beneficial bacteria and butyrate in young people...

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A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis
ClinicalTrials.gov

A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis

Phase 1 platform studies like this one test safety and tolerability of new treatments for moderate-to-severe ulcerative colitis before larger trials. Findings from such early studies determine whether a drug moves...

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A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting
ClinicalTrials.gov

A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting

People with moderate-to-severe Crohn's disease or ulcerative colitis and their clinicians may want to know how long patients stay on guselkumab in real-world care, since persistence reflects tolerability, benefit, and...

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A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis
ClinicalTrials.gov

A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis

Early-phase trials test safety and tolerability of new mechanisms; this study evaluates an anti–IL-18 antibody (aletekitug) which could represent a different therapeutic approach for people with moderate-to-severe UC if...

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An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
ClinicalTrials.gov

An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab

People with moderate-to-severe Crohn’s disease may be interested because the study explores a new, repurposed drug (vorinostat) that targets epigenetic and immune pathways and includes a plan to move responding...

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TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells and Inflammatory Bowel Disease
ClinicalTrials.gov

TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells and Inflammatory Bowel Disease

The study explores engineering HSPCs to induce IL-10–mediated, antigen-specific regulatory responses, which could lead to new cell-based strategies for children with refractory IBD who do not respond to current...

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Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
ClinicalTrials.gov

Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO

People with IBD sometimes are excluded from or uncertain about immune checkpoint inhibitor cancer trials because of concerns about triggering autoimmune flares. This trial explicitly studies safety and disease impact in...

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Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease.
ClinicalTrials.gov

Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease.

MR enterography is an important tool to measure transmural inflammation in ileal Crohn's disease, but many patients find the oral distension agents unpleasant. Demonstrating that non-distended MR enterography yields...

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Engineering allogeneic type 1 regulatory T cells: a scalable, off-the-shelf platform for restoring immune tolerance.
Frontiers in immunology

Engineering allogeneic type 1 regulatory T cells: a scalable, off-the-shelf platform for restoring immune tolerance.

This paper describes a new engineered, off-the-shelf regulatory T cell therapy (TRX103) designed to restore immune tolerance and that is already entering early clinical trials for treatment-refractory Crohn’s disease.

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A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis
ClinicalTrials.gov

A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis

This trial is testing whether a rectally delivered probiotic can change the gut microbiome and promote mucosal healing in people with mild-to-moderate ulcerative colitis (and includes some Crohn's patients). If...

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An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis
ClinicalTrials.gov

An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis

Patients with UC often take multiple medicines that rely on CYP enzymes. This study is checking if afimkibart affects how those drugs are processed, which could matter for safety or dosing if the drug proceeds in...

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Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease
ClinicalTrials.gov

Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease

Digital self-management programs could help people with active IBD build skills to manage symptoms and quality of life between clinic visits. This trial tests whether such a program is feasible, acceptable, and practical...

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