Gastroparesis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTAssess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula
Kate Farm Peptide 1.5 nutritional Formula
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Screening, Baseline and through end of study (12 weeks) | 9-item measure of severity of gastroparesis symptoms on a scale of 0-5 (none to worst) Higher values represent a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline through end of study (12 weeks) | 20-item measure of upper gastrointestinal symptom severity on a scale of 0-5 (none to worst) Higher values represent a worse outcome. |
| Total energy requirement | At Baseline and end of study (12 weeks) | Measurement of resting energy expenditure by indirect calorimetry |
| Inflammatory markers | Baseline through end of study (12 weeks) | CRP C-reactive protein |
| Weight | Baseline through end of study (12 weeks) | weight (kg) |
Countries
United States
Outcome results
None listed