Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2019-08-01
2022-08-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Assess Nutritional Effects of Nutritional Formula
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.
Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula
Kate Farm Peptide 1.5 nutritional Formula
Interventions
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Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula
Kate Farm Peptide 1.5 nutritional Formula
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Linda Nguyen
Clinical Associate Professor
Principal Investigators
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Linda Anh Nguyen, MD
Role: STUDY_DIRECTOR
Stanford University
Locations
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Stanford University School of Medicine
Redwood City, California, United States
Countries
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Other Identifiers
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50803
Identifier Type: -
Identifier Source: org_study_id
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