Use of SBI in IBS Subjects Following a Successful Treatment of Small Intestinal Bacterial Overgrowth
Condition: Diarrhea Predominant Irritable Bowel Syndrome; Small Intestinal Bacterial Overgrowth
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

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 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:

        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.
    

Intervention name(s): Serum-derived bovine immunoglobulin protein isolate (SBI); Placebo
Intervention type(s): Other; Other
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: DIBS; SIBO