Diarrhea Predominant Irritable Bowel SyndromeNCT02251483
Use of SBI in IBS Subjects Following a Successful Treatment of Small Intestinal Bacterial Overgrowth
A study testing Serum-derived bovine immunoglobulin protein isolate (SBI) in people with Diarrhea Predominant Irritable Bowel Syndrome and Small Intestinal Bacterial Overgrowth, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether giving SBI as a medical food starting with maintenance of health in the management of chronic loose and frequent stools in IBS-D subjects with SIBO after successful treatment with rifaximin can lead to more prolonged duration of benefit and delay symptom… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diarrhea Predominant Irritable Bowel Syndrome, Small Intestinal Bacterial Overgrowth
- What is being tested?
- Serum-derived bovine immunoglobulin protein isolate (SBI)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jul 2015
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-75 years old
- Meet Rome II criteria for IBS-D
- Meet criteria for SIBO
- If ≥50 years old, a colonoscopy must have been completed within the past 10 years
- Have just completed a course of antibiotic treatment with rifaximin and successfully responded to this treatment.
Who cannot join
- Had intestinal surgery (except appendectomy or cholecystectomy)
- Pelvic floor dysfunction
- Pregnancy or nursing mothers
- History of bowel obstruction
- History of celiac disease
- History of inflammatory bowel disease
Show all 11Show fewer
- Cirrhosis
- Diabetes
- Use of tricyclic antidepressants
- Use of antidiarrheal medications
- Allergy or hypersensitivity to beef or any component of SBI
Trial locations and contacts
1 site in 1 country.
United States1 site
GI Motility Program Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Use of Serum-derived Immunoglobulin/Protein Isolate (SBI) for the Maintenance of Health in Subjects With Irritable Bowel Syndrome (IBS) Following Successful Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
The primary objective of this study is to determine whether giving SBI as a medical food starting with maintenance of health in the management of chronic loose and frequent stools in IBS-D subjects with SIBO after successful treatment with rifaximin can lead to more prolonged duration of benefit and delay symptom recurrence. SBI is the main ingredient in EnteraGam™, an orally administered prescription medical food for the dietary management of patients with enteropathy or chronic loose or frequent stools, including patients with IBS-D.
Read the detailed description
Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders, with a global prevalence of 11%. IBS manifests itself in 3 major forms; diarrhea-predominant (IBS-D), constipation-predominant (IBS-C), and mixed (IBS-M), and is predominantly characterized by symptoms of abdominal pain, changes in stool frequency and consistency, and abdominal bloating.
SIBO is a condition in which there is an increase in the number of bacteria in the small bowel, and typically includes an overgrowth of coliform bacteria which are normally found in the colon. These ferment carbohydrates into gas (which can be measured using the lactulose breath test (LBT)), and the SIBO hypothesis proposes that it is this expansion of bacteria in the small bowel that leads to IBS symptoms including bloating, abdominal discomfort and changes in stool form. The antibiotic rifaximin is used to treat IBS-D, and has been shown to normalize the LBT in 70% of subjects. Despite this success, symptoms such as SIBO tend to recur, usually within 4 months of finishing the antibiotic treatment. Therefore, there remains a significant need to identify therapeutic agents which can maintain the health of subjects with IBS and SIBO and increase the duration of benefit in subjects with IBS and SIBO following antibiotic treatment.
SBI is intended for the dietary management of enteropathy under medical supervision in patients with chronic loose or frequent stools, including IBS-D patients. In vitro and animal studies have shown that SBI supports digestive and absorptive properties of the intestinal tracts by:
- Binding and neutralizing microbial components
- Helping to maintain beneficial gut microbiota
- Managing gut barrier function
- Maintaining GI immune balance
Clinical studies have also demonstrated that oral SBI improves nutrient absorption, nutritional status and GI symptoms in patients with HIV-associated enteropathy, IBS-D, or malnutrition. It is important to note that SBI is not used to treat patients with IBS-D or other enteropathies, but is given as a medical food to assist in the maintenance of health only.
This study will assess whether giving SBI as a medical food to subjects with IBS-D and SIBO after they successfully complete a course of rifaximin can lead to more prolonged maintenance of health and duration of benefit of antibiotic treatment in IBS-D patients.
- Being tested
- Serum-derived bovine immunoglobulin protein isolate (SBI), Placebo
- Keywords
- DIBS, SIBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum-derived bovine immunoglobulin protein isolate (SBI)Other
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| SBI | Other | Group 1: SBI (N=30) - one packet daily Receives: Other: Serum-derived bovine immunoglobulin protein isolate (SBI) |
| Placebo | Placebo comparator | Group 2: Placebo (N=30) - one packet daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse (symptom recurrence) in subjects with IBS-D after successful treatment with rifaximin
Measured: up to 4 months
Secondary outcomes (3)
Change in symptoms based on comparison of baseline symptom questionnaire to weekly symptom questionnaires
Measured: baseline and weekly questionnaires for up to 4 months
Comparison of baseline Bristol stool score based on 7 day stool diary
Measured: last week of every month for up to 4 months
Comparison of KT ratios in plasma samples
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea Predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Entera Health, Inc
- Responsible party
- Principal investigator, Mark Pimentel, MD, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251483
- Sponsor's protocol ID
- 35543
- Status last verified
- Jul 2015
- First submitted
- 17 Sep 2014
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Serum-derived Immunoglobulin/Protein Isolate (SBI) for the Maintenance of Health in Subjects With Irritable Bowel Syndrome (IBS) Following Successful Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
- ClinicalTrials.gov ID
- NCT02251483
- Acronym / sponsor ID
- 35543
- Keywords
- DIBS, SIBO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Entera Health, Inc
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Sep 2014 (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 primary objective of this study is to determine whether giving SBI as a medical food starting with maintenance of health in the management of chronic loose and frequent stools in IBS-D subjects with SIBO after successful treatment with rifaximin can lead to more prolonged duration of benefit and delay symptom recurrence. SBI is the main ingredient in EnteraGam™, an orally administered prescription medical food for the dietary management of patients with enteropathy or chronic loose or frequent stools, including patients with IBS-D.
Detailed description
Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders, with a global prevalence of 11%. IBS manifests itself in 3 major forms; diarrhea-predominant (IBS-D), constipation-predominant (IBS-C), and mixed (IBS-M), and is predominantly characterized by symptoms of abdominal pain, changes in stool frequency and consistency, and abdominal bloating.
SIBO is a condition in which there is an increase in the number of bacteria in the small bowel, and typically includes an overgrowth of coliform bacteria which are normally found in the colon. These ferment carbohydrates into gas (which can be measured using the lactulose breath test (LBT)), and the SIBO hypothesis proposes that it is this expansion of bacteria in the small bowel that leads to IBS symptoms including bloating, abdominal discomfort and changes in stool form. The antibiotic rifaximin is used to treat IBS-D, and has been shown to normalize the LBT in 70% of subjects. Despite this success, symptoms such as SIBO tend to recur, usually within 4 months of finishing the antibiotic treatment. Therefore, there remains a significant need to identify therapeutic agents which can maintain the health of subjects with IBS and SIBO and increase the duration of benefit in subjects with IBS and SIBO following antibiotic treatment.
SBI is intended for the dietary management of enteropathy under medical supervision in patients with chronic loose or frequent stools, including IBS-D patients. In vitro and animal studies have shown that SBI supports digestive and absorptive properties of the intestinal tracts by:
- Binding and neutralizing microbial components
- Helping to maintain beneficial gut microbiota
- Managing gut barrier function
- Maintaining GI immune balance
Clinical studies have also demonstrated that oral SBI improves nutrient absorption, nutritional status and GI symptoms in patients with HIV-associated enteropathy, IBS-D, or malnutrition. It is important to note that SBI is not used to treat patients with IBS-D or other enteropathies, but is given as a medical food to assist in the maintenance of health only.
This study will assess whether giving SBI as a medical food to subjects with IBS-D and SIBO after they successfully complete a course of rifaximin can lead to more prolonged maintenance of health and duration of benefit of antibiotic treatment in IBS-D patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBI | Other | Other: Serum-derived bovine immunoglobulin protein isolate (SBI)Group 1: SBI (N=30) - one packet daily |
| Placebo | Placebo comparator | Other: PlaceboGroup 2: Placebo (N=30) - one packet daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18-75 years old
- Meet Rome II criteria for IBS-D
- Meet criteria for SIBO
- If ≥50 years old, a colonoscopy must have been completed within the past 10 years
- Have just completed a course of antibiotic treatment with rifaximin and successfully responded to this treatment.
Key exclusion criteria (11 listed)
- Had intestinal surgery (except appendectomy or cholecystectomy)
- Pelvic floor dysfunction
- Pregnancy or nursing mothers
- History of bowel obstruction
- History of celiac disease
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 |
|---|---|---|
| Serum-derived bovine immunoglobulin protein isolate (SBI) | Other | SBI |
| Placebo | Other | Placebo |
Primary outcome
Time to relapse (symptom recurrence) in subjects with IBS-D after successful treatment with rifaximin
Time frame: up to 4 months
3 secondary outcomes
Change in symptoms based on comparison of baseline symptom questionnaire to weekly symptom questionnaires
Time frame: baseline and weekly questionnaires for up to 4 months
Comparison of baseline Bristol stool score based on 7 day stool diary
Time frame: last week of every month for up to 4 months
Comparison of KT ratios in plasma samples
Time frame: up to 4 months
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 29 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum-derived bovine immunoglobulin protein isolate (SBI) in people with Diarrhea Predominant Irritable Bowel Syndrome and Small Intestinal Bacterial Overgrowth, run by Cedars-Sinai Medical Center 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 5 inclusion and 11 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 29 Jul 2015. 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?
Time to relapse (symptom recurrence) in subjects with IBS-D after successful treatment with rifaximin (time frame: up to 4 months). 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 29 Jul 2015.