Irritable Bowel SyndromePhase 4NCT01641341
Irritable Bowel Syndrome Evaluation and Treatment in Primary Care
A Phase 4 study testing Bifidobacterium infantis, Pancrelipase and Nitazoxanide in people with Irritable Bowel Syndrome, run by American Academy of Family Physicians at 9 sites in United States.
Trial summary
Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced randomization and a cross-over to active treatment for placebo treated individuals who do not respond to the placebo treatment. Data collected will help determine the feasibility of the study design in primary care offices. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Bifidobacterium infantis, Pancrelipase and Nitazoxanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2010to Mar 2012
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 18 and 65 years of age
- meet Rome III criteria for IBS
- willing to complete surveys and daily symptom logs for three to four 14-day periods
- have positive symptoms for at least 3 days out of the 14 days of the baseline daily log records
Who cannot join
- have HIV or AIDs
- have gall stones with a gall bladder present
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Baton Rouge Family Practice
Baton Rouge, Louisiana, 70806
Southwest Family Medicine Associates
Dallas, Texas, 75235
Overland Park Family Health Partners
Leawood, Kansas, 66209
American Academy of Family Physicians-National Research Network
Leawood, Kansas, 66211
Torrance Clinical Research
Lomita, California, 90717
Raj Kachoria
Macedon, New York, 14502
Silver Sage Center for Family Medicine
Reno, Nevada, 89521
Family Medicine of SE Missouri
Sikeston, Missouri, 63801
Missouri Delta Physician Services
Sikeston, Missouri, 63801
About this study
Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced randomization and a cross-over to active treatment for placebo treated individuals who do not respond to the placebo treatment. Data collected will help determine the feasibility of the study design in primary care offices. Patient outcome data will provide a more precise estimate of power for a larger, classic randomized trial to determine if such a study can be reasonably undertaken within primary care practices.
Aims: The aims of this pilot study are to: 1) Evaluate how well Genova Diagnostics (GDx) IBS tests can be integrated into primary care, 2) examine the effects of the Genova Diagnostics (GDx) test on treatment, and 3) observe and track patients' health, quality of life and clinical outcomes related to IBS during the study period.
Read the detailed description
This study will take place in 8 practices which are members of the AAFP NRN. Eligible practices must be able to identify at least 25 active patients (seen in last 24 months) with a diagnosis of IBS from billing or electronic health record data to be eligible to participate. Each practice will be asked to recruit 10 patients.
Adult patients identified by their physician as having IBS symptoms will be termed "potentially eligible patients" and will be invited into the study via personal invitation when presenting at the practice on a regularly-scheduled visit, by letters mailed to these patients on practice letterhead and signed by the physician, or through phone contact with a member of the practice.
If a patient agrees to participate in the study, s/he will be asked to read and sign an initial informed consent. Consent forms will be included with the letters mailed to patients, and additional copies of the consent will be kept at the practice. The initial informed consent will cover consent for stool testing, for collection of all study outcome data including new diagnoses uncovered by the stool testing and any follow up procedures that are conducted as a result of the stool test results. This initial consent will indicate that based on stool testing results the patient may be referred for more evaluation or open label treatment from their physician or may be recommended for one or more study directed treatment(s).
Once the stool tests have returned the patient will be contacted to review these results. At that time the patient will be asked to sign a secondary consent form if study directed therapy is recommended. This consent form or these consent forms (if more than one therapy is recommended) will be treatment specific and explain that the patient will be randomized to active or placebo treatment in a double blinded fashion, that the patient will be crossed over to either active treatment or placebo after 8 weeks and that all patients will be offered active treatment by the end of the study.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Bifidobacterium infantis, Pancrelipase, Nitazoxanide, Placebo
- Keywords
- Irritable Bowel Syndrome, Genova Diagnostics kit, Stool test, Rome III, Practice-based research, treatable parasite, Pancreatic insufficiency, Bowel dysbiosis, High levels of inflammation, C. difficile, or H. pylori
- Medical subject headings
- Irritable Bowel Syndrome, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium infantisDrug
Also called B. Bifidum, B. Breve, B. Infantis, Bifidobacterias
once a day for seven to eight weeks
PancrelipaseDrug
Also called Lipancreatin
Pancrelipase (one capsule prior to meals or snacks)
NitazoxanideDrug
Also called Alinia
Nitazoxanide (500mg twice a day for 7 days)
PlaceboDrug
Also called Sugar pill
Placebo capsule will not contain active treatment ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Placebo capsule | Placebo comparator | Placebo capsule (sugar pill with no active medication) Receives: Drug: Placebo |
| Active treatment | Active comparator | Active treatment will consist of the following interventions:
1. Bowel Dysbiosis - probiotics Bifidobacterium infantis,
2. Maldigestion/Malabsorption - Pancrelipase
3. Parasitic infection/presence - Nitazoxanide Receives: Drug: Bifidobacterium infantis; Drug: Pancrelipase; Drug: Nitazoxanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
A reduction in IBS symptoms
20 to 40% of the control/placebo patients and approximately 70-75% of the treatment patients will experience a positive outcome as determined by both the daily log sheets and the modified Rome criteria administered at baseline, 8 and 16 weeks.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Academy of Family Physicians
- Sponsor type
- University, hospital or other
- Collaborators
- Genova Diagnostics
- Responsible party
- Sponsor
- Investigators
- Evelyn Lewis & Clark, MD, MA, Principal investigator, National Research NetworkWilson Pace, MD, Study chair, National Research NetworkGerard Mullin, MD, Study chair, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641341
- Sponsor's protocol ID
- 10-108
- Status last verified
- Jan 2019
- First submitted
- 9 May 2011
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irritable Bowel Syndrome Evaluation and Treatment in Primary Care
- ClinicalTrials.gov ID
- NCT01641341
- Acronym / sponsor ID
- 10-108
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Genova Diagnostics kit, Stool test, Rome III, Practice-based research, treatable parasite, Pancreatic insufficiency, Bowel dysbiosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- American Academy of Family PhysiciansUniversity, hospital or other
- Collaborators
- Genova Diagnostics
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Jul 2012 (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.
Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced randomization and a cross-over to active treatment for placebo treated individuals who do not respond to the placebo treatment. Data collected will help determine the feasibility of the study design in primary care offices. Patient outcome data will provide a more precise estimate of power for a larger, classic randomized trial to determine if such a study can be reasonably undertaken within primary care practices.
Aims: The aims of this pilot study are to: 1) Evaluate how well Genova Diagnostics (GDx) IBS tests can be integrated into primary care, 2) examine the effects of the Genova Diagnostics (GDx) test on treatment, and 3) observe and track patients' health, quality of life and clinical outcomes related to IBS during the study period.
Detailed description
This study will take place in 8 practices which are members of the AAFP NRN. Eligible practices must be able to identify at least 25 active patients (seen in last 24 months) with a diagnosis of IBS from billing or electronic health record data to be eligible to participate. Each practice will be asked to recruit 10 patients.
Adult patients identified by their physician as having IBS symptoms will be termed "potentially eligible patients" and will be invited into the study via personal invitation when presenting at the practice on a regularly-scheduled visit, by letters mailed to these patients on practice letterhead and signed by the physician, or through phone contact with a member of the practice.
If a patient agrees to participate in the study, s/he will be asked to read and sign an initial informed consent. Consent forms will be included with the letters mailed to patients, and additional copies of the consent will be kept at the practice. The initial informed consent will cover consent for stool testing, for collection of all study outcome data including new diagnoses uncovered by the stool testing and any follow up procedures that are conducted as a result of the stool test results. This initial consent will indicate that based on stool testing results the patient may be referred for more evaluation or open label treatment from their physician or may be recommended for one or more study directed treatment(s).
Once the stool tests have returned the patient will be contacted to review these results. At that time the patient will be asked to sign a secondary consent form if study directed therapy is recommended. This consent form or these consent forms (if more than one therapy is recommended) will be treatment specific and explain that the patient will be randomized to active or placebo treatment in a double blinded fashion, that the patient will be crossed over to either active treatment or placebo after 8 weeks and that all patients will be offered active treatment by the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo capsule | Placebo comparator | Drug: PlaceboPlacebo capsule (sugar pill with no active medication) |
| Active treatment | Active comparator | Drug: Bifidobacterium infantis, Drug: Pancrelipase, Drug: NitazoxanideActive treatment will consist of the following interventions: 1. Bowel Dysbiosis - probiotics Bifidobacterium infantis, 2. Maldigestion/Malabsorption - Pancrelipase 3. Parasitic infection/presence - Nitazoxanide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- between the ages of 18 and 65 years of age
- meet Rome III criteria for IBS
- willing to complete surveys and daily symptom logs for three to four 14-day periods
- have positive symptoms for at least 3 days out of the 14 days of the baseline daily log records
Key exclusion criteria (2 listed)
- have HIV or AIDs
- have gall stones with a gall bladder present
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 |
|---|---|---|
| Bifidobacterium infantisAlso: B. Bifidum, B. Breve, B. Infantis, Bifidobacteriasonce a day for seven to eight weeks | Drug | Active treatment |
| PancrelipaseAlso: LipancreatinPancrelipase (one capsule prior to meals or snacks) | Drug | Active treatment |
| NitazoxanideAlso: AliniaNitazoxanide (500mg twice a day for 7 days) | Drug | Active treatment |
| PlaceboAlso: Sugar pillPlacebo capsule will not contain active treatment ingredients. | Drug | Placebo capsule |
Primary outcome
A reduction in IBS symptoms
Time frame: 16 weeks
20 to 40% of the control/placebo patients and approximately 70-75% of the treatment patients will experience a positive outcome as determined by both the daily log sheets and the modified Rome criteria administered at baseline, 8 and 16 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 23 Jan 2019.
- 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.
Evelyn Lewis & Clark, MD, MA principal investigator
National Research Network
Wilson Pace, MD study chair
National Research Network
Gerard Mullin, MD study chair
Johns Hopkins School of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bifidobacterium infantis, Pancrelipase and Nitazoxanide in people with Irritable Bowel Syndrome, run by American Academy of Family Physicians at 9 sites 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 2 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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
A reduction in IBS symptoms (time frame: 16 weeks). 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 23 Jan 2019.