Study to Intervene With Nutrition for Gastroparesis (SING)

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.

Study Overview

• Status: Terminated
• Conditions: Gastroparesis
• Intervention / Treatment: Dietary supplement: Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Dietary supplement: Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula; Kate Farm Peptide 1.5 nutritional Formula; 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)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Director: Linda Anh Nguyen, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): August 18, 2022
• Study Completion (ACTUAL): August 18, 2022

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (ACTUAL): June 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: 50803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No