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.

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Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease
ClinicalTrials.gov

Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease

Patients and clinicians often seek adjunctive options to improve symptoms, quality of life, or reduce treatment burden. This trial tests whether Bacillus spore probiotics added to standard care can provide measurable...

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Accurately Profiling the Changes and Functions of Key Microflora in the Whole Intestinal Microenvironment Based on the Visual Sampling Capsule Endoscopy in Patients With Inflammatory Bowel Disease
ClinicalTrials.gov

Accurately Profiling the Changes and Functions of Key Microflora in the Whole Intestinal Microenvironment Based on the Visual Sampling Capsule Endoscopy in Patients With Inflammatory Bowel Disease

Mapping microbes and metabolites directly from different gut regions could reveal location-specific changes linked to IBD activity and help researchers develop better biomarkers or targeted treatments.

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Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
ClinicalTrials.gov

Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY

Faster, reliable reading of capsule endoscopy videos could shorten diagnostic delays and make small-bowel evaluation easier for people with suspected Crohn’s disease. If AI preserves accuracy while reducing review time,...

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Acceptability, Adherence, and Impact on the Bioavailability of Iron and Zinc of the Dietary Supplements Goodphyte IB Defense and Goodphyte Immunity in Adults With Chronic Diseases.
ClinicalTrials.gov

Acceptability, Adherence, and Impact on the Bioavailability of Iron and Zinc of the Dietary Supplements Goodphyte IB Defense and Goodphyte Immunity in Adults With Chronic Diseases.

IBD patients sometimes have low iron or zinc and may try supplements. This trial tested whether two phytase-containing dietary supplements are acceptable and whether they change iron and zinc absorption in adults with...

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A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
ClinicalTrials.gov

A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease

This registry will track long-term safety and clinical outcomes in children with IBD, with a focus on infliximab (an anti‑TNF biologic) versus non‑biologic therapies. Long follow-up could help identify uncommon or late...

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Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study
ClinicalTrials.gov

Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study

Perianal fistulizing Crohn’s disease is difficult to treat and many patients don’t respond to available medical and surgical options. This trial tests an existing wound‑healing therapy (HBOT) in a formal controlled...

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A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants
ClinicalTrials.gov

A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants

Researchers and patients tracking new IBD therapies may care because this is the first human study of a GlaxoSmithKline investigational drug aimed at colitis/ulcerative colitis — an early step that could lead to future...

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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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