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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutamine Group | Active Comparator | Subjects will receive glutamine for 28 days. |
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| Placebo Group | Placebo Comparator | Subjects will receive placebo for 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutamine | Drug | 5 gram powder, one rounded teaspoon, dissolved in 8 ounces of water or juice prior to drinking) taken orally three times per day |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, 4 weeks |
| Changes in small bowel intestinal permeability | Assessed using the validated lactulose: mannitol urine test | Baseline, 4 weeks |
| Adverse Events | Number of adverse events (serious and non-serious) reported | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Cangemi, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Torsak Vimoktayon | Jacksonville | Florida | 32258 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Placebo | Drug | 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. |
|
| D021542 | Amino Acids, Neutral |