Study to Intervene With Nutrition for Gastroparesis

Study Overview
=================
Brief Summary
-----------------
The study is a self-controlled study in which we will assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula in patients with gastroparesis, relative to their pre-enrollment nutritional diet regimen.

Detailed Description
-----------------
The study is a prospective self-controlled study in which we will assess the nutritional effects of Kate Farm Peptide 1.5 nutritional formula in patients with gastroparesis, relative to their pre-enrollment diet regimen. The duration of the study will be 12 weeks. We plan to recruit a total of 30 patients. Patients will undergo a baseline measurement of their height, weight, symptom burden, resting energy expenditure, inflammation, and microbiome. After study initiation, patient will undergo repeat testing at 1- and 3-months post-enrollment. Including the screening and baseline visits, there will be a total of 4 visits required to complete the study.

Official Title
-----------------
Study to Intervene With Nutrition for Gastroparesis

Conditions
-----------------
Gastroparesis

Intervention / Treatment
-----------------
* Dietary Supplement: Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Identify inclusion criteria. Male or female gender Ages 18 to 65 Established diagnosis of gastroparesis confirmed by gastric emptying study within the last 5 years. No changes to gastroparesis medications in the 3 months prior to recruitment. Patients with hysterectomy, appendectomy, cholecystectomy and fundoplication are ok to participate. Able to give informed consent. Patient willing to supplement diet with Kate Farms Ability to adhere to the study visit schedule and other protocol requirements. Identify exclusion criteria. Are nursing or pregnant. Diagnosis of mechanical small bowel obstruction within 3 months prior to recruitment Patients with a history of gastric surgery, including gastrectomy, small bowel resection or bariatric surgery The use of narcotic medications in the month prior to study enrollment or during the study period Diagnosis of short gut syndrome Allergic to any ingredients in the Kate Farms formula Untreated small intestinal bacterial overgrowth

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Assess Nutritional Effects of Nutritional Formula<br>Self-controlled study in which we will assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula in patients with gastroparesis, relative to their pre-enrollment nutritional formula regimen. | Dietary Supplement: Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula<br>* Kate Farm Peptide 1.5 nutritional Formula<br>* Other names: Study to Intervene with Nutrition for Gastroparesis;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Gastroparesis Cardinal Symptom Index (GCSI) Symptoms Index (GCSI) score as measure of the effect of KF Peptide 1.5 nutritional formula. | 9-item measure of severity of gastroparesis symptoms on a scale of 0-5 (none to worst) Higher values represent a worse outcome. | Screening, Baseline and through end of study (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) Disorders-Symptom Severity Index (PAGI-SYM) score as measure of the effect of KF Peptide 1.5 nutritional formula. | 20-item measure of upper gastrointestinal symptom severity on a scale of 0-5 (none to worst) Higher values represent a worse outcome. | Baseline through end of study (12 weeks) | 
| Total energy requirement | Measurement of resting energy expenditure by indirect calorimetry | At Baseline and end of study (12 weeks) | 
| Inflammatory markers | CRP C-reactive protein | Baseline through end of study (12 weeks) | 
| Weight | weight (kg) | Baseline through end of study (12 weeks) |