Use of SBI in IBS Subjects Following a Successful Treatment of Small Intestinal Bacterial Overgrowth
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS) |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | July 2015 |
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.
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.
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:
1. Binding and neutralizing microbial components
2. Helping to maintain beneficial gut microbiota
3. Managing gut barrier function
4. 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.
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:
1. Binding and neutralizing microbial components
2. Helping to maintain beneficial gut microbiota
3. Managing gut barrier function
4. 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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Cirrhosis
- Diabetes
- Use of tricyclic antidepressants
- Use of antidiarrheal medications
- Allergy or hypersensitivity to beef or any component of SBI
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