Study to Intervene With Nutrition for Gastroparesis

NCT03987672 | Terminated

• 1 other identifier: 50803
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• Total energy requirement

  At Baseline and end of study (12 weeks)

• Inflammatory markers

  Baseline through end of study (12 weeks)

• Weight

  Baseline through end of study (12 weeks)

Study Arms (1)

Assess Nutritional Effects of Nutritional Formula

OTHER

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

Interventions

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

Kate Farm Peptide 1.5 nutritional Formula

Also known as: Study to Intervene with Nutrition for Gastroparesis

Assess Nutritional Effects of Nutritional Formula

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Linda Anh Nguyen, MD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: August 1, 2019
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)