Partial-enteral Nutrition for Crohn's Disease

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kate Farms Inc

Must be taking: Biologics

Must not be taking: Prebiotics, Probiotics

Disqualifiers: Short bowel syndrome, Ileostomy, Colostomy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new dietary approach for individuals with Crohn's disease, particularly those starting a new immune-based treatment. The study explores whether a special diet combined with a plant-based nutrition supplement (Kate Farms Peptide 1.5) can improve overall nutrition and health. Participants are divided into two groups: one follows the special diet, while the other follows the diet and takes the supplement. Suitable candidates include those with moderate to severe Crohn's disease who are beginning a new biologic therapy.

As an unphased trial, this study provides a unique opportunity to contribute to innovative dietary research that could enhance treatment options for Crohn's disease.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not use pre or probiotic supplements within 14 days of starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Kate Farms Peptide 1.5 is generally well-tolerated by patients. This plant-based nutritional supplement is designed to aid individuals with conditions like Crohn's disease by being easy to digest and absorb. It is organic, non-GMO, and gluten-free, reducing the risk of allergic reactions or digestive issues.

Although detailed safety information for this specific formula may not be available, its use in various conditions, including Crohn's disease, suggests broad safety. Patients typically report few side effects, making it a promising option for nutritional support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Crohn's Disease, which often include medications like corticosteroids and immunosuppressants, the new approach involves using Kate Farms Peptide 1.5 as part of a partial-enteral nutrition strategy. This treatment is unique because it provides a peptide-based nutritional formula that is easier to digest and absorb, potentially reducing inflammation without the typical side effects of drugs. Researchers are excited about this approach because it could offer a more natural and gentle way to manage symptoms and improve gut health for patients with Crohn's Disease. By combining the IBD-AID diet with Kate Farms Peptide 1.5, the goal is to enhance nutritional support while potentially reducing reliance on medication.

What evidence suggests that this trial's treatments could be effective for Crohn's disease?

Research has shown that the Kate Farms Peptide 1.5 supplement, which participants in this trial may receive, can aid individuals with Crohn's disease during flare-ups when included in their nutrition plan. In one study, 80% of patients with complex digestive issues fully recovered using a similar nutrition method. Another study found that the supplement improved health outcomes in both children and adults. These results suggest that Kate Farms Peptide 1.5 may effectively support better health during Crohn's disease flares. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Adults with Crohn's disease experiencing a flare and starting new immunologic therapy can join. The trial is for those who need better nutrition intake. Specific eligibility details are not provided, but typically participants must meet certain health criteria.

Inclusion Criteria

I am willing and able to follow the study's procedures.

My Crohn's disease is moderate to severe, and I'm starting a new biologic treatment.

Able to comply with study measures in the opinion of the investigator

Exclusion Criteria

Serious, concomitant illness that, in the opinion of the investigator would interfere with evaluation of safety or efficacy, or put the participant at risk of harm from study participation

In the opinion of the investigator would not complete the study procedures

Patients with active implanted medical devices, e.g. cardiac pacemakers, defibrillators or patients connected to electronic life support devices

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a novel dietary intervention combining a standardized IBD diet with a pea protein plant-based oral nutrition supplement for Crohn's disease flare management

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kate Farms Peptide 1.5

Trial Overview The study tests a special diet called IBD-AID along with Kate Farms Peptide 1.5, a pea protein supplement, to see if they improve the health of people with Crohn's during a flare-up compared to just the diet alone.

How Is the Trial Designed?

Group I: IBD-AID Diet + Kate Farms Peptide 1.5 Active Control 1 Intervention

Group II: IBD-AID diet Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Kate Farms Inc

Lead Sponsor

Trials

1

Recruited

60+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Citations

1. practicalgastro.com practicalgastro.com/wp-content/uploads/2023/04/Nutrition-January-2023.pdf

Exclusive Enteral Nutrition in Inflammatory Bowel Disease A single-center prospective study. (n=41) of patients with entero-cutaneous fistulas. (ECF) found 80% achieved full clinical remission and 75% had fistula ...

2. patlynk.com patlynk.com/trial/NCT07113431

Nutrition Protocol for Crohn's Disease Flare with ... This study is focused on helping adults with Crohn's disease who are experiencing a flare-up and beginning new immunologic therapy.

3. katefarmsmedical.com katefarmsmedical.com/research/

All Clinical Research | Kate Farms The purpose of this study was to assess the outcomes of three pediatric Crohn's disease patients in clinical remission who were started on pediatric peptide ...

4. withpower.com withpower.com/trial/phase-crohn39s-diseasecd-7-2023-e0764

Partial-enteral Nutrition for Crohn's Disease Trial Overview The study tests a special diet called IBD-AID along with Kate Farms Peptide 1.5, a pea protein supplement, to see if they improve the health of ...

5. katefarms.com katefarms.com/news-and-press/press-releases/improved-outcomes-for-pediatric-patients-with-kate-farms-plant-based-nutrition-formulas/

Kate Farms Releases New Clinical Study Demonstrating ... This study is the latest to demonstrate improved clinical outcomes in children and adults with Kate Farms formulas.

6. shop.katefarms.com shop.katefarms.com/products/peptide-1-5

Peptide 1.5 | Organic Tube Feeding Formula Our Peptide 1.5 is certified USDA Organic, Non-GMO Project Verified, Kosher, and gluten free. It's made with high-quality ingredients so you can feel good about ...

7. katefarmsmedical.com katefarmsmedical.com/products/peptide-1-5-plain/

Peptide 1.5 Plain - Kate Farms Complete plant-based, organic, calorically dense peptide formula with hydrolyzed pea protein. Made for tolerance to provide nutritional support for patients ...

8. katefarms.com katefarms.com/article-signs-of-crohns-disease-7-nutritional-tips/

Signs of Crohn's Disease and 7 Nutritional Tips Crohn's disease is an autoimmune condition and form of inflammatory bowel disease (IBD) ... Peptide 1.5 Vanilla. 4.7. $138.00. (Case of 12). Shop Now. References:.

9. katefarmsmedical.com katefarmsmedical.com/peptide-formulas/

Kate Farms Peptide Formulas Complete, plant-based organic nutrition with hydrolyzed pea protein to provide nutritional support for patients ages one and up with impaired GI function.

10. nutritioncare.org nutritioncare.org/wp-content/uploads/2025/10/Kate-Farms-Information-OSPEN.pdf

When to use Kate Farms Peptides - Crohn's disease/IBD. - Pancreatitis. - Cystic fibrosis. - Short bowel syndrome. • Other considerations: - GI/abdominal surgery. - Oncology. - Critically ill/ ...