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Study to Intervene With Nutrition for Gastroparesis (SING)

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ClinicalTrials.gov Identifier: NCT03987672
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Linda Nguyen, Stanford University

Brief Summary:
The study is a self-controlled study in which we will assess the safety and efficacy of Kate Farm Peptide 1.5 tube feeding in patients with gastroparesis, relative to their pre-enrollment tube feeding regimen.

Condition or disease Intervention/treatment Phase
Gastroparesis Dietary Supplement: Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Study to Intervene With Nutrition for Gastroparesis
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Study to Intervene with Nutrition for Gastroparesis




Primary Outcome Measures :
  1. Change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score as measure of the effect of KF Peptide 1.5 nutritional formula. [ Time Frame: Baseline through end of study (12 weeks) ]

Secondary Outcome Measures :
  1. Change from baseline in Gastroparesis Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) score as measure of the effect of KF Peptide 1.5 nutritional formula. [ Time Frame: Baseline through end of study (12 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female gender
  • Ages 18 to 65
  • Established diagnosis of gastroparesis confirmed by gastric emptying study within the last 2 years.
  • No changes to gastroparesis medications in the 3 months prior to recruitment.
  • Jejunostomy tube placed greater than or equal to 1 year prior to recruitment.
  • Greater than or equal to 70% of daily caloric intake (DCI) from tube feeds.
  • Able to give informed consent.

Exclusion Criteria:

  • Diagnosis of mechanical small bowel obstruction within 3 months 2 years prior to recruitment
  • Patients with a history of gastric surgery, including fundoplication, gastrectomy, or any bariatric procedure
  • The use of narcotic medications in the month prior to study enrollment or during the study period
  • Diagnosis of short gut syndrome
  • Diagnosis of small intestinal bacterial overgrowth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987672


Contacts
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Contact: Dr. Linda Nguyen, MD (650)736-5555 nguyenlb@stanford.edu

Sponsors and Collaborators
Stanford University
Investigators
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Study Director: Dr. Linda Nguyen, MD Clinic Director, Digestive Health Center, Director, Neurogastroenterology & Motility

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Responsible Party: Linda Nguyen, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03987672     History of Changes
Other Study ID Numbers: 50803
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms