Study to Intervene With Nutrition for Gastroparesis (SING)

Stanford University

Status: Terminated

Conditions: Gastroparesis

Treatments: Dietary Supplement: Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT03987672

50803

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Assess Nutritional Effects of Nutritional Formula

Other group

Description:

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.

Treatment:

Dietary Supplement: Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula