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Study to Intervene With Nutrition for Gastroparesis (SING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03987672
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : September 9, 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

Detailed Description:

The study is a prospective self-controlled study in which we will assess the nutritional effects of Kate Farm Peptide 1.5 tube feeding in patients with gastroparesis, relative to their pre-enrollment tube feeding 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Study to Intervene With Nutrition for Gastroparesis
Actual Study Start Date : August 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 Symptom Index (GCSI) Symptoms Index (GCSI) score as measure of the effect of KF Peptide 1.5 nutritional formula. [ Time Frame: 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 :
  1. 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. [ Time Frame: 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.


  2. Total energy requirement [ Time Frame: At Baseline and end of study (12 weeks) ]
    Measurement of resting energy expenditure by indirect calorimetry

  3. Inflammatory markers [ Time Frame: Baseline through end of study (12 weeks) ]
    CRP C-reactive protein

  4. Weight [ Time Frame: Baseline through end of study (12 weeks) ]
    weight (kg)



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.
  • Patients with hysterectomy, appendectomy, cholecystectomy and fundoplication are ok to participate.
  • 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.
  • Ability to adhere to the study visit schedule and other protocol requirements.

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.
  • 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: Elvi Sanjines, MS (650)721-8614 marias1@stanford.edu
Contact: Alexandria George (650)723-6815 alexandria.george@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Redwood City, California, United States, 94063
Contact: Elvi Sanjines    650-721-8614    marias1@stanford.edu   
Contact: Alexandria George    (650)723-6815    alexandria.george@stanford.edu   
Principal Investigator: Linda Anh Nguyen, MD         
Sub-Investigator: Christopher Gardner, PhD         
Sponsors and Collaborators
Stanford University
Investigators
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Study Director: Linda Anh Nguyen, MD Stanford University
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Responsible Party: Linda Nguyen, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03987672    
Other Study ID Numbers: 50803
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 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