search
Back to results

A Study of Glutamine to Treat Intestinal Permeability in Functional Dyspepsia

Primary Purpose

Functional Dyspepsia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glutamine
Placebo
Sponsored by
David J. Cangemi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meet Rome IV criteria for functional dyspepsia (https://theromefoundation.org/rome-iv/rome-iv-criteria/) Patients will generally be in good health. During initial evaluation, patients' symptoms will be assessed and patients categorized into either the PDS, EPS or mixed subtype of FD. Exclusion Criteria: Significant comorbid illness Symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or if the patients have known esophagitis, eosinophilic esophagitis or H. pylori. Prior surgery to the esophagus, stomach or duodenum will be excluded, as will those taking proton pump inhibitors (PPIs), opioids, corticosteroids and those taking regular (daily) antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), or mast-cell stabilizing agents within the prior 2 weeks. Of note, patients taking PPIs will be given the opportunity to discontinue their PPI in favor of famotidine 20 mg daily for 2 weeks before enrollment. Known allergies to lactulose: mannitol. Active tobacco use and excessive alcohol use (defined as 8 or more drinks per week for women or 15 or more drinks per week for men; http://ww.cdc.gov) Co-existing IBS will be allowed to enter the study as long as symptoms are not predominant. Hepatic and renal impairment within the past 6 months. Defined as AST/ALT > 2X ULN, Total Bilirubin > 2 X ULN, Estimated Glomerular Filtration Rate (eGFR) of < 60 mL/min/BSA. Diagnosed with galactosemia. Pregnant or breastfeeding women. Patients with documented or reported lactose intolerance.

Sites / Locations

  • Torsak VimoktayonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Glutamine Group

Placebo Group

Arm Description

Subjects will receive glutamine for 28 days.

Subjects will receive placebo for 28 days.

Outcomes

Primary Outcome Measures

Change in Functional Dyspepsia symptoms
Assessed by the validated self-reported Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire total score. 20-item questionnaire measuring severity of symptoms related to gastrointestinal problem on scale from 0 = no symptoms to 5=very severe. Total score range 0-100 with higher score indicating greater severity of gastrointestinal symptoms.
Change in symptoms of bloating
Assessed by the validated self-reported Mayo Bloating questionnaire (MBQ). 45-item questionnaire to describe symptoms of bloating and distension.
Changes in small bowel intestinal permeability
Assessed using the validated lactulose: mannitol urine test
Adverse Events
Number of adverse events (serious and non-serious) reported

Secondary Outcome Measures

Full Information

First Posted
December 9, 2022
Last Updated
March 8, 2023
Sponsor
David J. Cangemi
search

1. Study Identification

Unique Protocol Identification Number
NCT05655819
Brief Title
A Study of Glutamine to Treat Intestinal Permeability in Functional Dyspepsia
Official Title
A Randomized, Placebo-Controlled Trial Assessing the Effect of Glutamine on Intestinal Permeability and Symptoms in Patients With Functional Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David J. Cangemi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to collect data from patients diagnosed with functional dyspepsia who are treated with glutamine and describe safety and treatment results compared to patients taking a placebo. Glutamine, an essential amino acid in humans, is an important energy source for cells lining the gastrointestinal tract and has been shown to play an important role in regulating the strength of the intestinal wall.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glutamine Group
Arm Type
Active Comparator
Arm Description
Subjects will receive glutamine for 28 days.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo for 28 days.
Intervention Type
Drug
Intervention Name(s)
Glutamine
Intervention Description
5 gram powder, one rounded teaspoon, dissolved in 8 ounces of water or juice prior to drinking) taken orally three times per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lactose powder dissolved in 8 ounces of water or juice prior to drinking, taken orally three times per day. Looks exactly like the study drug, but it contains no active ingredient.
Primary Outcome Measure Information:
Title
Change in Functional Dyspepsia symptoms
Description
Assessed by the validated self-reported Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire total score. 20-item questionnaire measuring severity of symptoms related to gastrointestinal problem on scale from 0 = no symptoms to 5=very severe. Total score range 0-100 with higher score indicating greater severity of gastrointestinal symptoms.
Time Frame
Baseline, 4 weeks
Title
Change in symptoms of bloating
Description
Assessed by the validated self-reported Mayo Bloating questionnaire (MBQ). 45-item questionnaire to describe symptoms of bloating and distension.
Time Frame
Baseline, 4 weeks
Title
Changes in small bowel intestinal permeability
Description
Assessed using the validated lactulose: mannitol urine test
Time Frame
Baseline, 4 weeks
Title
Adverse Events
Description
Number of adverse events (serious and non-serious) reported
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet Rome IV criteria for functional dyspepsia (https://theromefoundation.org/rome-iv/rome-iv-criteria/) Patients will generally be in good health. During initial evaluation, patients' symptoms will be assessed and patients categorized into either the PDS, EPS or mixed subtype of FD. Exclusion Criteria: Significant comorbid illness Symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or if the patients have known esophagitis, eosinophilic esophagitis or H. pylori. Prior surgery to the esophagus, stomach or duodenum will be excluded, as will those taking proton pump inhibitors (PPIs), opioids, corticosteroids and those taking regular (daily) antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), or mast-cell stabilizing agents within the prior 2 weeks. Of note, patients taking PPIs will be given the opportunity to discontinue their PPI in favor of famotidine 20 mg daily for 2 weeks before enrollment. Known allergies to lactulose: mannitol. Active tobacco use and excessive alcohol use (defined as 8 or more drinks per week for women or 15 or more drinks per week for men; http://ww.cdc.gov) Co-existing IBS will be allowed to enter the study as long as symptoms are not predominant. Hepatic and renal impairment within the past 6 months. Defined as AST/ALT > 2X ULN, Total Bilirubin > 2 X ULN, Estimated Glomerular Filtration Rate (eGFR) of < 60 mL/min/BSA. Diagnosed with galactosemia. Pregnant or breastfeeding women. Patients with documented or reported lactose intolerance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Torsak Vimoktayon
Phone
904-953-3238
Email
Vimoktayon.Torsak@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cangemi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Torsak Vimoktayon
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torsak Vimoktayon
Phone
904-233-3674
Email
vimoktayon.torsak@mayo.edu
First Name & Middle Initial & Last Name & Degree
Wendi Lehman

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

A Study of Glutamine to Treat Intestinal Permeability in Functional Dyspepsia

We'll reach out to this number within 24 hrs