Study to Intervene With Nutrition for Gastroparesis

Gastroparesis Clinical Trial

— SING  

Official title:

Study to Intervene With Nutrition for Gastroparesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03987672
• Other study ID #: 50803
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 18, 2022

Study information

• Verified date: August 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 18, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Total energy requirement	Measurement of resting energy expenditure by indirect calorimetry	At Baseline and end of study (12 weeks)
Secondary	Inflammatory markers	CRP C-reactive protein	Baseline through end of study (12 weeks)
Secondary	Weight	weight (kg)	Baseline through end of study (12 weeks)