Recruiting

Enteral Nutrition

Sponsor:

James Lewis

Code:

NCT07426003

Conditions

Enteral Nutrition's Effect on the Gut

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Kate Farms Peptide 1.5

Crohn's disease exclusion diet

Study Details

Brief summary:

This research study is being conducted to determine the effects of enteral nutrition on healthy people. Enteral nutrition for the purpose of this study refers to the use of a specially developed formula taken by mouth that provides all essential nutrition either in the absence of food or to supplement the intake of foods. Enteral nutrition can be used for many reasons, such as to gain or lose weight, to treat food allergies, or to reduce inflammation in certain intestinal diseases. We would like to understand the effects of enteral nutrition in the absence of intestinal inflammation.

Conditions

Enteral Nutrition's Effect on the Gut

Study ID

NCT07426003

Start date

Jun 17, 2026

Status verified date

Aug, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Must be able to read and understand English
2. Must be able to sign a consent form for the study

Exclusion Criteria:

1. BMI <20 or >30
2. Unintentional weight loss of >10% in the last 3-6 months
3. Kidney disease
4. Diagnosis of cirrhosis
5. Taking diuretics
6. Anemia - Hemoglobin <lower limit of normal in men or <10 g/dL in women.
7. Taking iron supplements within 2 weeks for Visit 2.1
8. Taking prebiotic or probiotic supplements or any supplement including a multivitamin within 2 weeks of Visit 2.1
9. Taking antibiotics less than 4 weeks prior to Visit 2.1
10. Diarrhea in the 2 weeks prior to Visit 2.1
11. Diabetes mellitus
12. Diagnosis of congestive heart failure
13. Diagnosis of inflammatory bowel disease or celiac disease
14. Bowel resection other than an appendectomy
15. Pregnancy or breastfeeding
16. Intolerance or allergy to nutritional formula, chicken, eggs, apples, banana, potatoes
17. Using protein supplements, including powder added to food or drinks within 2 weeks of Visit 2.1
18. Baseline bowel frequency less than every 2 days or greater than 3 times daily
19. Student or employee of any one of the investigators.
20. Anyone who cannot receive study payment (e.g. visa constraints).
21. Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Partial Enteral Nutrition and the Crohn's Disease Exclusion Diet

Participants will drink Kate Farms Peptide 1.5 for 60% of their calories and follow the Crohn's Disease Exclusion Diet for the remainder of their calories

active comparator: Exclusive enteral nutrition

Participants will consume Kate Farms Peptide 1.5 exclusively except water, and coffee and tea with no sweetner or cream/milk for 3 days

Interventions

Kate Farms Peptide 1.5

Kate Farms Peptide 1.5

Crohn's disease exclusion diet

This study will use the components of the Crohn's disease exclusion diet Phase 1 which includes chicken breast, eggs, potatoes, bananas and apples

Primary outcome measure

  • number of sitz markers at 72 hours [ Time Frame: 72 hours after taking the sitzmark capsule ]

Central Contacts and Locations

Central contacts

Locations

Penn Center for Advance Medicine, University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

James Lewis

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • enteral nutrition
  • healthy volunteers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by James Lewis on 2026-08-06.