Clinical trial NCT03987672: Study to Intervene With Nutrition for Gastroparesis
Official title: Study to Intervene With Nutrition for Gastroparesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroparesis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 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.
timeFrame: Screening, Baseline and through end of study (12 weeks)
Secondary outcomes:
measure: 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.
timeFrame: Baseline through end of study (12 weeks)
measure: Total energy requirement
timeFrame: At Baseline and end of study (12 weeks)
measure: Inflammatory markers
timeFrame: Baseline through end of study (12 weeks)
measure: Weight
timeFrame: Baseline through end of study (12 weeks)
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Linda Anh Nguyen, MD
role: STUDY_DIRECTOR
References: