Study to Intervene With Nutrition for Gastroparesis

Not Applicable

Terminated

• Conditions: Gastroparesis
• Interventions: Dietary Supplement: Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula

• Registration Number: NCT03987672
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-17
• Study Start: 2019-08-01
• Status Verified: 2022-08
• Primary Completion: 2022-08-18
• Study Completion: 2022-08-18
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assess Nutritional Effects of Nutritional Formula	Assess the nutritional effects of the Kate Farm Peptide 1.5 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Inflammatory markers	Baseline through end of study (12 weeks)	CRP C-reactive protein
Weight	Baseline through end of study (12 weeks)	weight (kg)
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

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Redwood City, California, United States