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

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Background: Bacteria that live inside the stomach and intestines are important for health. Chronic granulomatous disease (CGD) and inflammatory bowel disease (IBD) can make people have unhealthy bacteria. This can lead to gastrointestinal (GI) problems. Researchers want to see if people with CGD and IBD feel better when they change the bacteria in the stomach by following a special liquid diet. Objective: To see if an elemental diet can change the bacteria in the stomach and intestines of people with CGD and IBD. Also, to see if this helps GI symptoms. Eligibility: People ages 8-65 years with CGD, CGD-associated colitis, and IBD. Design: Participants will first be screened with: Upper GI endoscopy and/or colonoscopy. A long, thin tube with a tiny camera at the end will be passed into the participant s body through the mouth or anus. Tissue will be collected. Participants will be sedated for the procedure. They will be sedated using a special mask or small plastic tube placed in an arm vein using a needle. Participants will be put on the special diet for up to 4 weeks. They will stay in the hospital for up to 2 weeks. They will have check-ups. They will have blood, urine, and stool samples collected. They will keep a symptom diary to record how they feel and any GI symptoms. Participants will have 2 follow-up visits. The first will be right after they finish the diet. The second will be 4 weeks later. They will have blood, urine, and stool samples collected. They will learn about re-introducing other foods into their diet.

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 the elemental diet safe for humans?

Research shows that an elemental diet can be safely administered to patients with inflammatory bowel disease, with only temporary mild symptoms like nausea and bloating in some cases. ^{1 2 3 4 5}

How is the treatment Neocate Splash unique for inflammatory bowel disease?

Neocate Splash, an elemental diet, is unique because it provides nutrition in a form that is easily absorbed by the body, reducing inflammation and improving intestinal integrity without the need for starter regimens. It is administered through a nasogastric tube, allowing for constant infusion, which can lead to increased nutrient intake and improved nitrogen balance, making it different from traditional drug therapies. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Neocate Splash for inflammatory bowel disease?

Research shows that elemental diets can reduce symptoms like stool frequency and inflammation in patients with inflammatory bowel disease, suggesting that Neocate Splash, as an elemental diet, might be effective in managing these conditions. ^{1 2 6 8 10}

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

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Elemental diet administered nasogastrically without starter regimens to patients with inflammatory bowel disease. [2017]

2. Japan pubmed.ncbi.nlm.nih.gov

Adherence to an elemental diet for preventing postoperative recurrence of Crohn's disease. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

[Adjuvant therapy with elemental diet in chronic inflammatory intestinal diseases. Comparative study]. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Diet in Treatment of Inflammatory Bowel Diseases. [2022]

5. Norway pubmed.ncbi.nlm.nih.gov

Elemental versus polymeric enteral nutrition in paediatric Crohn's disease: a multicentre randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Nutrition and diet in inflammatory bowel disease. [2023]

7. Zimbabwe pubmed.ncbi.nlm.nih.gov

The serum concentrations of zinc, copper and selenium in children with inflammatory bowel disease. [2013]

8. Australia pubmed.ncbi.nlm.nih.gov

Current state of dietetic services for inflammatory bowel disease patients in New Zealand: an observational study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The effect of elemental diet on intestinal permeability and inflammation in Crohn's disease. [2019]

10. Austria pubmed.ncbi.nlm.nih.gov

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