Functional DyspepsiaPhase 1/2NCT05655819
A Study of Glutamine to Treat Intestinal Permeability in Functional Dyspepsia
A Phase 1/2 study testing Glutamine in people with Functional Dyspepsia, run by David J. Cangemi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Glutamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2023to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled Trial Assessing the Effect of Glutamine on Intestinal Permeability and Symptoms in Patients With Functional Dyspepsia
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.
- Conditions
- Functional Dyspepsia
- Being tested
- Glutamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDrug
5 gram powder, one rounded teaspoon, dissolved in 8 ounces of water or juice prior to drinking) taken orally three times per day
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Glutamine Group | Active comparator | Subjects will receive glutamine for 28 days. Receives: Drug: Glutamine |
| Placebo Group | Placebo comparator | Subjects will receive placebo for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
Changes in small bowel intestinal permeability
Assessed using the validated lactulose: mannitol urine test
Measured: Baseline, 4 weeks
Adverse Events
Number of adverse events (serious and non-serious) reported
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start16 Feb 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- David J. Cangemi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David J. Cangemi, Mayo Clinic
- Investigators
- David Cangemi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655819
- Sponsor's protocol ID
- 22-004343
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Trial Assessing the Effect of Glutamine on Intestinal Permeability and Symptoms in Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT05655819
- Acronym / sponsor ID
- 22-004343
- Conditions
- Functional Dyspepsia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- David J. CangemiUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine Group | Active comparator | Drug: GlutamineSubjects will receive glutamine for 28 days. |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects will receive placebo for 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glutamine5 gram powder, one rounded teaspoon, dissolved in 8 ounces of water or juice prior to drinking) taken orally three times per day | Drug | Glutamine Group |
| PlaceboLactose 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. | Drug | Placebo Group |
Primary outcome
Change in Functional Dyspepsia symptoms
Time frame: Baseline, 4 weeks
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
Time frame: Baseline, 4 weeks
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
Time frame: Baseline, 4 weeks
Assessed using the validated lactulose: mannitol urine test
Adverse Events
Time frame: 4 weeks
Number of adverse events (serious and non-serious) reported
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cangemi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Glutamine in people with Functional Dyspepsia, run by David J. Cangemi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Dyspepsia symptoms (time frame: Baseline, 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.