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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-AAAB6531(Y3M00) | Other Identifier | Columbia University Medical Center IRB |
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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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Celiac disease is a condition in which the small intestine is damaged by gluten, the storage protein of wheat and similar proteins in barley and rye. The disease can cause different symptoms such as diarrhea, bloating, abdominal pain and weight loss. The majority of patients respond to a gluten-free diet. However some patients (5-30%) have persistent symptoms and are considered to be poor responders to the diet. Bacterial overgrowth in the small intestine accounts for some of the refractory patients.
This study seeks to determine if antibiotic therapy with rifaximin relieves the symptoms of patients who are poorly responsive to a gluten-free diet and whether this impacts their breath test results.
A symptom questionnaire will be administered at study initiation, 2 weeks and 12 weeks. Patients will undergo a breath test which involves drinking a sugar (lactulose) solution and breathing into a machine. This technique will identify the presence of bacteria in the small intestine. They will be randomly selected to receive either an antibiotic (rifaximin) or placebo three times a day for 10 days to treat their bacterial overgrowth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin 400mg | Experimental | Antibiotic ,Rifaximin 400mg, given 3 times a day for 10 days. |
|
| Placebo | Placebo Comparator | Placebo pills given 3 times a day for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | Rifaximin 400mg orally three times a day for 10 days total |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score | Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort. | Baseline (week 0) |
| Week 2 Gastrointestinal Symptom Rating Scale (GSRS) Score | Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort. | Week 2 |
| Week 12 Gastrointestinal Symptom Rating Scale (GSRS) Score | Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Abnormal Breath Test | A breath test measures for small intestine bacterial overgrowth (SIBO). The breath test measures the amount of hydrogen exhaled after drinking a sugar (lactulose) solution. An abnormal breath test is defined as: 1) a rise in hydrogen of ≥20 parts per million (ppm) within 100 minutes, or 2) two peaks ≥20 ppm over baseline. | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
antibiotic use for any indication within preceding one month
use of bismuth compounds within preceding month
concomitant use of pancreatic supplements
concomitant use of antispasmodics
concomitant use of immunomodulators such as corticosteroids, budesonide, alkylating agents and antimetabolites.
concomitant use of probiotics
concomitant use of prokinetic agents
concomitant use of 5-hydroxytryptamine receptor (5HT3) antagonists,5-hydroxytryptamine receptor (5HT4) antagonists.
concomitant use of antimotility agents (e.g loperamide)
concomitant use of antidiarrheal agents
diagnosed microscopic colitis or inflammatory bowel disease
other causes of malabsorption: pancreatic insufficiency, giardiasis and enteropathy associated with T cell lymphoma.
other diseases: renal or hepatic insufficiency.
pregnant patients and lactating females. In addition women of child bearing age will be excluded if they are not using one of the methods of contraception like oral contraceptives,intrauterine device.
and double barrier methods.
patients with tuberculosis or a positive purified protein derivative (PPD) test and infection with other mycobacterial diseases.
allergy and/or potential emergence of drug resistance to rifampicin and rifamycin compounds.
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| Name | Affiliation | Role |
|---|---|---|
| Peter HR Green, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celiac Disease Center at Columbia University | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21647654 | Result | Chang MS, Minaya MT, Cheng J, Connor BA, Lewis SK, Green PH. Double-blind randomized controlled trial of rifaximin for persistent symptoms in patients with celiac disease. Dig Dis Sci. 2011 Oct;56(10):2939-46. doi: 10.1007/s10620-011-1719-6. Epub 2011 Jun 7. |
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Fifty participants were enrolled and 41 participants completed the trial.
Recruited from Celiac Disease Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rifaximin | Antibiotic ( 25 subjects) 400 mg capsules of Rifaximin 3 times a day for 10 days. |
| FG001 | Placebo | Inert capsules ( 25 Subjects) Placebo capsules 3 times a day for 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rifaximin | Antibiotic ( 25 subjects) 400 mg capsules of Rifaximin 3 times a day for 10 days. |
| BG001 | Placebo | Inert capsules ( 25 Subjects) Placebo capsules 3 times a day for 10 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score | Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (week 0) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rifaximin | Antibiotic: Rifaximin 400mg orally three times a day for 10 days total |
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Small sample size. Challenges of diagnosing bacterial overgrowth.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Green | Celiac Disease Center at Columbia University | (212) 305-5590 | mtm2111@columbia.edu |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo orally three times a day for 10 days total |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Week 2 Gastrointestinal Symptom Rating Scale (GSRS) Score | Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort. | Posted | Mean | Standard Deviation | score on a scale | Week 2 |
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| Secondary | Percentage of Participants With Abnormal Breath Test | A breath test measures for small intestine bacterial overgrowth (SIBO). The breath test measures the amount of hydrogen exhaled after drinking a sugar (lactulose) solution. An abnormal breath test is defined as: 1) a rise in hydrogen of ≥20 parts per million (ppm) within 100 minutes, or 2) two peaks ≥20 ppm over baseline. | Posted | Number | Percent of Participants | Up to 12 weeks |
|
|
|
| Primary | Week 12 Gastrointestinal Symptom Rating Scale (GSRS) Score | Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | Inert capsules: Placebo orally three times a day for 10 days total | 0 | 21 | 0 | 21 |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |