Elemental Diet for Inflammatory Bowel Disease

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an elemental diet, a special liquid diet, can benefit individuals with chronic granulomatous disease (CGD) and inflammatory bowel disease (IBD) by altering the bacteria in their stomach and intestines. Researchers seek to discover if this diet can alleviate gastrointestinal symptoms such as stomach pain or diarrhea. Suitable candidates for this trial include those diagnosed with CGD or IBD who experience symptoms impacting their daily lives. Participants will follow the diet, specifically using Neocate Splash, for up to four weeks and will stay in the hospital for part of the time to monitor changes. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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 active infections requiring antibiotics, other than known preventive medications, are excluded, which might imply some restrictions. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that Neocate Splash, the treatment being tested, is usually easy for people to handle. This special drink, made from amino acids, is unlikely to cause allergic reactions. Studies have found it safe for individuals with cow milk allergies and other food allergies. Most people do not experience serious side effects, though some might have mild issues like changes in bowel movements or stomach discomfort. Using Neocate Splash under a doctor's guidance is important to ensure safety and proper nutrition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Neocate Splash is unique because it offers a nutritional approach to managing Inflammatory Bowel Disease (IBD) that differs from standard treatments like anti-inflammatory drugs, immunosuppressants, and biologics. Unlike these medications, which focus on reducing inflammation or modulating the immune system, Neocate Splash is an elemental diet. This means it provides easily digestible nutrients in their simplest form, which can be gentler on the digestive tract and potentially reduce symptoms without the side effects associated with medications. Researchers are excited about this treatment because it offers a non-pharmacological option that could improve patients' quality of life by minimizing gastrointestinal distress and promoting nutritional absorption.

What evidence suggests that this elemental diet is effective for inflammatory bowel disease?

Research has shown that special diets like Neocate Splash, which participants in this trial will follow, can help people with inflammatory bowel disease (IBD) by altering gut bacteria. Neocate Splash has been proven to reduce gut inflammation. In one study, 17 adults followed a similar diet for four weeks and experienced reduced inflammation. This diet replaces regular food with a liquid formula that provides all necessary nutrients. Consequently, it can improve digestive symptoms by supporting healthier gut bacteria. ^{3 4 6 7 8}

Who Is on the Research Team?

Christa S Zerbe, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

This trial is for people aged 8-65 with Chronic Granulomatous Disease (CGD) and Inflammatory Bowel Disease (IBD). They should have certain levels of disease activity, be willing to stay in the hospital for up to two weeks, and consent to genetic testing. Pregnant individuals or those with conditions that make participation unsafe are excluded.

Inclusion Criteria

Able to provide informed consent

I am willing to have genetic tests done on my samples.

I am between 8 and 65 years old.

Exclusion Criteria

Pregnancy

Any condition that, in the opinion of the investigator, contraindicates participation in this study will be excluded from study participation.

I am currently on antibiotics for an infection, not just for prevention.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants are put on a special elemental diet for up to 4 weeks, with inpatient stay for up to 2 weeks

4 weeks

Inpatient stay for up to 2 weeks

Follow-up

Participants have 2 follow-up visits to monitor changes in microbiome and reintroduce normal food

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Neocate Splash

Trial Overview The study tests if an elemental diet called Neocate Splash can improve gut health by changing stomach bacteria in patients with CGD and IBD. Participants will follow this liquid diet for up to four weeks, starting with a hospital stay, while their symptoms and health markers are monitored.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

Participants will be on this diet for 4 weeks. The amount per serving will be determined on the basis of the participant s weight and caloric needs, as determined by a staff dietician.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

Elemental diets, used alongside drug therapy, show therapeutic effectiveness in treating active Crohn's disease, particularly in cases of small bowel involvement, comparable to traditional treatments like salazosulfapyridine and corticosteroids.

The elemental diet leads to physiological changes that may contribute to its effectiveness, such as reduced gastric and pancreatic secretions, altered gut bacteria, and improved nutrient absorption, making it suitable for conditions like acute small bowel disease and malnourishment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Status of elemental diets in the therapy of Crohn disease in childhood]. Kirchmann, HM.[2009]

Diet plays a significant role in the onset and severity of inflammatory bowel diseases (IBDs), as it can influence immune system regulation and intestinal health.

While enteral nutrition is effective for treating pediatric Crohn's disease, there is a lack of research on the impact of whole food dietary interventions, highlighting the need for further studies to explore dietary patterns and their potential in managing IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet in Treatment of Inflammatory Bowel Diseases. Sasson, AN., Ananthakrishnan, AN., Raman, M.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11415405/

Elemental Diet as a Therapeutic Modality Fat composition of elemental diet is also important as high large-chain triglyceride content has been linked to lower efficacy of ED in CD [17].

2. withpower.com withpower.com/trial/phase-3-inflammatory-bowel-diseases-5-2021-6e553

Elemental Diet for Inflammatory Bowel Disease Trial Overview The study tests if an elemental diet called Neocate Splash can improve gut health by changing stomach bacteria in patients with CGD and IBD.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03983837?cond=(GLUCOCORTICOID%20DEFICIENCY)%20OR%20(MC2R)&rank=4

Elemental Diet for Treatment of Inflammatory Bowel ... In this study, we propose to treat 5 patients >= 8 years old who have CGD and IBD with 4 weeks of an elemental diet.

4. neocate.com neocate.com/wp-content/uploads/2020/06/Neocate-Clinical-Evidence-Research.pdf?srsltid=AfmBOoqszul6Ep2ZPATfxTJzew2wMLu1SiSWjKkRA9S1p3LldkDs7Z_W

Supported by more than 30 years of scientific research 17 adults with EoE successfully adhered to a 4-week elemental diet using flavored liquid AAF (Neocate Splash). ... Elemental diet decreases inflammation.

5. mdpi.com mdpi.com/2072-6643/17/11/1879

Dietary Interventions and Oral Nutritional Supplementation ... The results demonstrated that 49.4% of patients in the low-emulfisier diet group achieved a clinical response (defined as a ≥70-point reduction in ...

6. neocate.com neocate.com/wp-content/uploads/2017/11/2021-US-PRG-8MB.pdf?srsltid=AfmBOorHFDTJPQF3Sk0QPpn_SNHMLxD0wAt9_fjedlu9yrWXHOP4VH5F

NUTRICIA PRODUCT REFERENCE GUIDE This guide is a convenient reference for clinicians to the full range of Nutricia's medical nutritional products. Nutricia strives to develop quality ...

7. neocate.com neocate.com/for-healthcare-professionals/?srsltid=AfmBOooe0RRkg7GXGsuyK7CJ3GserFnd0sorpj5NUmlwwC-tZLI3KxgQ

Neocate for Healthcare Professionals Neocate is a family of hypoallergenic, amino acid-based medical foods for use under medical supervision and is indicated for cow milk allergy.

8. nutricialearningcenter.com nutricialearningcenter.com/globalassets/pdfs/gi-allergy/neocate-evidence-booklet-2018.pdf

Neocate® Neocate products are indicated for use in the dietary management of cow milk allergy, multiple food allergies and related gastrointestinal and allergic ...