Healthy Volunteers Enteral Nutrition Study (HEN)

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
James Lewis
Study ID
NCT07426003
Status
Recruiting

Conditions

  • Enteral Nutrition's Effect on the Gut

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Kate Farms Peptide 1.5 — DIETARY_SUPPLEMENT
    Kate Farms Peptide 1.5
  • Crohn's disease exclusion diet — OTHER
    This study will use the components of the Crohn's disease exclusion diet Phase 1 which includes chicken breast, eggs, potatoes, bananas and apples

Study Details

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.

Key Dates

Start date
Jun 17, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn Center for Advance Medicine, University of PennsylvaniaPhiladelphiaPennsylvania19104
Alesia Smith
445-242-3237

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