Back to results

Study to Intervene With Nutrition for Gastroparesis (SING)

Primary Purpose

Gastroparesis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula

About this trial

This is an interventional supportive care trial for Gastroparesis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Assess Nutritional Effects of Nutritional Formula

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Total energy requirement

Measurement of resting energy expenditure by indirect calorimetry

Inflammatory markers

CRP C-reactive protein

Weight

weight (kg)

Full Information

NCT ID

NCT03987672

First Posted

June 12, 2019

Last Updated

August 18, 2022

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03987672

Brief Title

Study to Intervene With Nutrition for Gastroparesis

Acronym

SING

Official Title

Study to Intervene With Nutrition for Gastroparesis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

Recruitment challenges

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

August 18, 2022 (Actual)

Study Completion Date

August 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroparesis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Assess Nutritional Effects of Nutritional Formula

Arm Type

Other

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula

Other Intervention Name(s)

Study to Intervene with Nutrition for Gastroparesis

Intervention Description

Kate Farm Peptide 1.5 nutritional Formula

Primary Outcome Measure Information:

Title

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.

Description

9-item measure of severity of gastroparesis symptoms on a scale of 0-5 (none to worst) Higher values represent a worse outcome.

Time Frame

Screening, Baseline and through end of study (12 weeks)

Secondary Outcome Measure Information:

Title

Description

20-item measure of upper gastrointestinal symptom severity on a scale of 0-5 (none to worst) Higher values represent a worse outcome.

Time Frame

Baseline through end of study (12 weeks)

Title

Total energy requirement

Description

Measurement of resting energy expenditure by indirect calorimetry

Time Frame

At Baseline and end of study (12 weeks)

Title

Inflammatory markers

Description

CRP C-reactive protein

Time Frame

Baseline through end of study (12 weeks)

Title

Weight

Description

weight (kg)

Time Frame

Baseline through end of study (12 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda Anh Nguyen, MD

Organizational Affiliation

Stanford University

Official's Role

Study Director

Facility Information:

Facility Name

Stanford University School of Medicine

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study to Intervene With Nutrition for Gastroparesis

We'll reach out to this number within 24 hrs