An interventional study of Serum-derived bovine immunoglobulin protein isolate (SBI) and Placebo in Diarrhea Predominant Irritable Bowel Syndrome and Small Intestinal Bacterial Overgrowth, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-07-29.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Supportive care
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.
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:
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.
Cedars-Sinai Medical Center is the lead sponsor of 455 studies on the registry; 108 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.
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Exclusion Criteria:
Group 1: SBI (N=30) - one packet daily
Other: Serum-derived bovine immunoglobulin protein isolate (SBI)
Group 2: Placebo (N=30) - one packet daily
Other: Placebo
Time to relapse (symptom recurrence) in subjects with IBS-D after successful treatment with rifaximin
Time frame: up to 4 months
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
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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