Functional DyspepsiaNCT00956397
Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia
A study testing Rifaximin and Lactulose Breath Test in people with Functional Dyspepsia and Small Intestinal Bacterial Overgrowth, run by Henry C. Lin, MD at 1 site in United States.
Trial summary
The prevalence of functional dyspepsia (FD) is estimated to be 15% of the adult population. FD is commonly described as a condition of chronic abdominal discomfort localized to the upper abdomen. Postprandial bloating, pain, nausea, vomiting, belching, and early satiety are common symptoms of the FD patient. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia, Small Intestinal Bacterial Overgrowth, Chronic Abdominal Discomfort
- What is being tested?
- Rifaximin and Lactulose Breath Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Mar 2012
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have FD based on the most recent Umbrella criteria of one or more of: a. bothersome postprandial fullness, b. early satiation, c. epigastric pain, d. epigastric burning
- No evidence of organic disease (including H. pylori detected at time of endoscopy) that is likely to explain the symptoms
- Criteria must be fulfilled for the last 3 months with symptom onset at least 6 months before the diagnosis
- The physical exam, routine blood tests including CBC, chemistry panel and liver tests, upper gastrointestinal endoscopy and 24h pH study must be normal
Who cannot join
- History of IBS,rheumatoid arthritis,H. Pylori infection,lupus,peptic ulcer, cirrhosis,diabetes, HIV or TB
- Inflammatory bowel disease
- Bowel Resection (including gastric, small bowel or colon; gallbladder surgery or appendectomy are NOT exclusion criteria)
- Anti/pro-biotics last 3 months
- Previous LBT (Lactulose Breath Test)
- Narcotic Dependence
- Pregnancy
- Control subjects will be excluded if they have symptoms of heartburn, retrosternal chest pain, chronic cough, nausea or regurgitation suggestive of gastroesophageal reflux disease
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center
Albuquerque, New Mexico, 87131
About this study
The prevalence of functional dyspepsia (FD) is estimated to be 15% of the adult population. FD is commonly described as a condition of chronic abdominal discomfort localized to the upper abdomen. Postprandial bloating, pain, nausea, vomiting, belching, and early satiety are common symptoms of the FD patient. FD is defined by >12 weeks of symptoms, which need not be consecutive, within the preceding year consisting of a) persistent or recurrent dyspepsia and b) an absence of organic disease after a gastrointestinal endoscopy or x-ray series. FD is therefore considered a disorder of function because no mucosal pathology is seen in these patients, as in patients with other functional disorders such as irritable bowel syndrome (IBS) and fibromyalgia (FM). There is a remarkable degree of overlap among these three disorders. These 3 disorders share the finding of hypersensitivity and the symptom of postprandial bloating to suggest the possibility of a common origin.
- Being tested
- Rifaximin, Lactulose Breath Test, Placebo
- Keywords
- Functional Dyspepsia, Small Intestinal Bacterial Overgrowth, chronic abdominal discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Xifaxan
rifaximin 550 mg TID PO x 10 days
Lactulose Breath TestProcedure or surgery
Test will begin with a baseline breath sample followed by ingestion of 10g of lactulose (Xactdose, South Beloit, IL) in 100ml of water. Breath samples will be collected every 15 min for 180 min. Gas samples will be analyzed for hydrogen and methane using a gas chromatograph (Model SC, Quintron Instruments, Milwaukee, WI).
PlaceboDrug
placebo TID x 10 days
| Study group | Role | What they receive |
|---|---|---|
| Control Participants | Active comparator | Not described Receives: Procedure: Lactulose Breath Test |
| FD Participants | Active comparator | Not described Receives: Drug: Rifaximin; Procedure: Lactulose Breath Test |
| FD (Placebo) Participants | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT
Measured: every 15 minutes for 180 minutes
Secondary outcomes (1)
The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startAug 2007
- Primary completionMar 2012
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry C. Lin, MD
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Henry C. Lin, MD, New Mexico VA Healthcare System
- Investigators
- Henry C Lin, MD, Principal investigator, New Mexico VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956397
- Sponsor's protocol ID
- HRRC 07-187
- Other IDs
- 5R21DK078101-02
- Status last verified
- Oct 2012
- First submitted
- 10 Aug 2009
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT00956397
- Acronym / sponsor ID
- HRRC 07-187
- Keywords
- Functional Dyspepsia, Small Intestinal Bacterial Overgrowth, chronic abdominal discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Henry C. Lin, MDUS federal agency
- Study start
- Aug 2007
- Primary completion
- Mar 2012 (actual)
- First posted
- 11 Aug 2009 (estimated)
- 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 prevalence of functional dyspepsia (FD) is estimated to be 15% of the adult population. FD is commonly described as a condition of chronic abdominal discomfort localized to the upper abdomen. Postprandial bloating, pain, nausea, vomiting, belching, and early satiety are common symptoms of the FD patient. FD is defined by >12 weeks of symptoms, which need not be consecutive, within the preceding year consisting of a) persistent or recurrent dyspepsia and b) an absence of organic disease after a gastrointestinal endoscopy or x-ray series. FD is therefore considered a disorder of function because no mucosal pathology is seen in these patients, as in patients with other functional disorders such as irritable bowel syndrome (IBS) and fibromyalgia (FM). There is a remarkable degree of overlap among these three disorders. These 3 disorders share the finding of hypersensitivity and the symptom of postprandial bloating to suggest the possibility of a common origin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Participants | Active comparator | Procedure: Lactulose Breath Test |
| FD Participants | Active comparator | Drug: Rifaximin, Procedure: Lactulose Breath Test |
| FD (Placebo) Participants | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have FD based on the most recent Umbrella criteria of one or more of: a. bothersome postprandial fullness, b. early satiation, c. epigastric pain, d. epigastric burning
- No evidence of organic disease (including H. pylori detected at time of endoscopy) that is likely to explain the symptoms
- Criteria must be fulfilled for the last 3 months with symptom onset at least 6 months before the diagnosis
- The physical exam, routine blood tests including CBC, chemistry panel and liver tests, upper gastrointestinal endoscopy and 24h pH study must be normal
Key exclusion criteria (8 listed)
- History of IBS,rheumatoid arthritis,H. Pylori infection,lupus,peptic ulcer, cirrhosis,diabetes, HIV or TB
- Inflammatory bowel disease
- Bowel Resection (including gastric, small bowel or colon; gallbladder surgery or appendectomy are NOT exclusion criteria)
- Anti/pro-biotics last 3 months
- Previous LBT (Lactulose Breath Test)
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 |
|---|---|---|
| RifaximinAlso: Xifaxanrifaximin 550 mg TID PO x 10 days | Drug | FD Participants |
| Lactulose Breath TestTest will begin with a baseline breath sample followed by ingestion of 10g of lactulose (Xactdose, South Beloit, IL) in 100ml of water. Breath samples will be collected every 15 min for 180 min. Gas samples will be analyzed for hydrogen and methane using a gas chromatograph (Model SC, Quintron Instruments, Milwaukee, WI). | Procedure or surgery | Control Participants, FD Participants |
| Placeboplacebo TID x 10 days | Drug | FD (Placebo) Participants |
Primary outcome
To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT
Time frame: every 15 minutes for 180 minutes
1 secondary outcome
The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment
Time frame: 2 weeks
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 24 Oct 2012.
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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.
Henry C Lin, MD principal investigator
New Mexico VA Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifaximin and Lactulose Breath Test in people with Functional Dyspepsia and Small Intestinal Bacterial Overgrowth, run by Henry C. Lin, MD 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 4 inclusion and 8 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 24 Oct 2012. 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.
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?
To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT (time frame: every 15 minutes for 180 minutes). 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 24 Oct 2012.