Inflammatory Bowel Disease (IBD), which includes Crohn’s disease and ulcerative colitis, is a chronic condition that significantly impacts the lives of millions worldwide.

While current treatments help manage symptoms, many patients still struggle with flare-ups, medication side effects, and limited long-term solutions.

Clinical trials are at the forefront of advancing treatments, discovering new therapies, and improving the overall quality of life for IBD patients.

These studies play a vital role in bringing innovative treatments to market, refining existing therapies, and offering patients access to cutting-edge care.

In this article, we’ll explore:

✅ What clinical trials are and how they work
✅ How they improve treatment options for IBD
✅ The impact on patient quality of life
✅ How to participate in a trial

Understanding Clinical Trials: A Gateway to New Treatments

A clinical trial is a research study designed to test new treatments, drugs, medical procedures, or lifestyle interventions.

These studies ensure that potential treatments are safe, effective, and beneficial before they become widely available.

Clinical trials for IBD focus on:

• New medications (biologics, small molecules, or alternative therapies)
• Optimizing existing treatments (better dosing schedules, combining therapies)
• Exploring new diet and lifestyle interventions
• Non-invasive procedures or novel diagnostic tools 

The Phases of Clinical Trials

Clinical trials progress through four key phases before a treatment is approved for widespread use:

Phase 1 – Safety Testing:

• Small group of participants (20–100).
• Focuses on safety, side effect 

Phase 2 – Effectiveness Testing:

• Larger group of IBD patients (100–300).
• Assesses how well the drug works, safety and dosage. 

Phase 3 – Large-Scale Testing:

• Thousands of participants across multiple locations.
• Compares new treatment to or placebo.
• Refines dosage, safety 

Phase 4 – Post-Approval Studies:

• Conducted after FDA approval.
• Monitors long-term safety, effectiveness, and real-world impact.
• Usually compares trial drug against existing treatment 

Each phase is essential in ensuring a new treatment meets the highest standards before it is introduced to the public.

How Clinical Trials Are Transforming IBD Treatment

1. More Effective & Targeted Therapies

Traditional IBD treatments like steroids and immunosuppressants often come with severe side effects. Clinical trials are driving innovation by introducing more targeted therapies like:

• Biologics – These medications, like TNF inhibitors (infliximab, adalimumab) and IL-23 inhibitors (risankizumab, guselkumab), target specific immune pathways to reduce inflammation.
• JAK Inhibitors – Small molecule drugs like tofacitinib and upadacitinib that block immune signaling, offering an alternative for biologic-resistant patients.
• S1P Receptor Modulators – New oral therapies like ozanimod that prevent immune cells from attacking the intestines.
• Microbiome-Based Therapies – Research into probiotics and fecal microbiota transplants (FMT) to restore gut bacteria balance.

These cutting-edge treatments can help patients achieve long-term remission with fewer side effects.

2. Personalized Medicine: Tailoring Treatments to the Individual

Not all IBD patients respond to treatments the same way. Clinical trials are helping doctors identify biomarkers that predict how a patient will respond to a specific medication.

This means:

✔ More effective treatments with fewer failed attempts.
✔ Fewer side effects by avoiding unnecessary medications.
✔ Faster symptom relief with tailored therapies.

Advances in genetic testing and precision medicine are leading to a future where IBD treatment is customized to each patient’s needs.

3. Less Invasive Procedures & Improved Diagnostics

Clinical trials are also testing:

• New imaging techniques (better endoscopic cameras, AI-assisted diagnostics).
• Non-invasive stool or blood tests to monitor inflammation.
• Capsule endoscopy advancements to reduce the need for colonoscopies.

This means fewer invasive procedures, less discomfort, and faster diagnoses for patients.

4. Better Long-Term Disease Management

Many IBD patients experience cycles of flare-ups and remission. Clinical trials are exploring:

• Early intervention strategies to prevent flares before they start.
• Long-term medication adjustments to maintain remission safely.
• Lifestyle-based treatments (diet, stress management, exercise).

These research efforts help patients maintain a better quality of life and reduce hospitalizations.

How Clinical Trials Improve Quality of Life for IBD Patients

Many patients participating in trials experience:

• Access to groundbreaking treatments before they’re available to the public.
• Reduced symptoms & longer remission with innovative therapies.
• Close monitoring & expert care from top medical professionals.
• Reduced financial burden – trials often cover medication and medical visits.

For patients struggling with treatment-resistant IBD, clinical trials offer hope and new possibilities when other treatments fail.

How to Participate in a Clinical Trial

If you’re interested in joining a clinical trial, follow these steps:

1. Talk to Your Gastroenterologist

Your doctor can help determine if a trial is right for you and refer you to clinical trial centers.

2. Search for Trials Online

✅ ClinicalTrials.gov
✅ Crohn’s & Colitis Foundation
✅ Local hospitals and research centers often list available trials.

3. Check Eligibility Criteria

Each trial has specific criteria based on:

• Diagnosis (Crohn’s or UC)
• Age & health condition
• Current medications

What to Expect During a Clinical Trial

Once you enroll, you’ll go through these steps:

✔ Screening & Consent: Doctors review your health, risks, and benefits before you sign up.
✔ Randomization & Treatment: You may receive the new treatment or a placebo (comparison group).
✔ Monitoring & Follow-Ups: Regular check-ups track your progress and side effects.

Participation is voluntary, and you can leave at any time if you feel uncomfortable.

Are Clinical Trials Safe?

Patient safety is the top priority in clinical research.

• Strict FDA, SAHPRA and Pharmaethics regulations ensure ethical and safe testing.
• Independent monitoring boards oversee data for safety concerns.
• Informed consent ensures participants understand risks and benefits.

While every treatment has risks, clinical trials follow rigorous guidelines to minimize them.

Final Thoughts: Should You Consider a Clinical Trial?

If you’re struggling with uncontrolled symptoms, medication side effects, or treatment failures, a clinical trial could be a life-changing opportunity.

By participating, you not only gain access to cutting-edge therapies, but you also contribute to the future of IBD treatment, helping millions of patients worldwide.

Talk to your doctor today to explore your options!

More About Spoke Research

Spoke Research Inc. is a clinical research organization based in Cape Town, South Africa, dedicated to advancing the understanding and treatment of Inflammatory Bowel Diseases (IBD), specifically Ulcerative Colitis and Crohn’s Disease.

Established in 2017, Spoke Research conducts clinical trials, medical surveys, and specialized research to develop more effective therapies for these chronic conditions.

Mission and Objectives

The primary mission of Spoke Research is to contribute to the medical knowledge of IBD by:

• Conducting Clinical Trials: Evaluating new treatments and therapies to determine their safety and efficacy.
• Medical Surveys: Assessing prospective patients to identify suitable candidates for clinical trials.
• IBD Research: Investigating the underlying causes and potential treatments for IBD. 

Clinical Trials and Studies

Spoke Research specializes in clinical trials for Ulcerative Colitis and Crohn’s Disease, aiming to develop new treatments and improve patient outcomes.

The organization recruits patient volunteers on behalf of pharmaceutical companies and international Contract Research Organizations (CROs).

All clinical trials are approved by the South African Health Products Regulatory Authority (SAHPRA) and have received full ethics approval.

Team of Professionals

The team at Spoke Research comprises experienced medical professionals:

• George: A research doctor with qualifications including MBBCH, DCH, and DTM&H. Dr. George has a background in general practice for over 20 years and has been involved in clinical research since 2017.
• Deetlefs: A gastroenterologist with qualifications including MBChB, FCP(SA), and a Certificate in Gastroenterology. Dr. Deetlefs has been in private practice since 2011 and practices from Vincent Pallotti Hospital
• Vanesha Naidoo: An experienced study nurse who completed her training at St. Aidan’s School of Nursing in Durban. Vanesha joined Spoke Research in 2017 as an Inflammatory Bowel Disease study nurse.

Contact Dr. Gosia George

If you’d like to take part in a clinical trial, join us here:

Apply for Crohn’s Disease Trial

Apply for Ulcerative Colitis Trial

We are here to provide you with expert medical advice in the field of clinical research with years of experience.

Contact us to find out more on clinical trials and treatment.