A Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Participants With Functional Gastrointestinal Disturbances
A Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Participants With Functional Gastrointestinal Disturbances
The primary objective of this study is to assess the safety and efficacy of Salix Probiotic
 Blend, administered orally for 30 days, in participants with functional gastrointestinal (GI)
 disturbances.
Inclusion Criteria:

 -  Participants who have symptoms of GI disturbances.

 -  Participant has recurrent abdominal pain, discomfort, bloating, and/or abdominal
 distention associated with a change in the frequency of stool and/or a change in the
 form (appearance) of stool.

 -  Participant is able to understand the nature and purpose of the study and provide
 informed consent.

 -  Sexually active males and sexually active females of child-bearing potential, defined
 as neither surgically sterile nor post-menopausal (that is, females age >45 years and
 no menstrual periods for at least 1 year), must agree to use a highly effective method
 of contraception from Screening to 30 days post last dose of study product. Acceptable
 forms of contraception include the following:

 -  Abstinence

 -  Oral, injected, or implanted hormonal methods of contraception

 -  Intrauterine device or intrauterine contraceptive system

 -  Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal
 foam/gel/film/cream/suppository

 -  Female whose last sexual intercourse with males was ≥6 months post-vasectomy

 Exclusion Criteria:

 -  Participant has active or a history of inflammatory bowel disease.

 -  Participant has other significant systemic diseases such as active cancer therapy,
 active/ongoing infection, uncontrolled diabetes, chronic renal failure, cirrhosis,
 congestive heart failure, and severe Chronic Obstructive Pulmonary Disease (COPD).

 -  Participant has used antipsychotic medications within 3 months prior to Screening.

 -  Participant has used systemic steroids within the month prior to Screening.

 -  Participant has suffered from a major psychiatric disorder within the past 2 years.

 -  Participant is pregnant or breastfeeding.

 -  Participant has a known lactose intolerance.

 -  Participant is immunocompromised or has an immunodeficiency syndrome of any kind.

 -  Participant has undergone any abdominal surgery, except for hernia repair or
 appendectomy.

 -  Participant has had active treatment with prescription medication for irritable bowel
 syndrome (IBS) within 6 weeks prior to Screening.

 -  Participant has been diagnosed with infectious gastroenteritis within 1 month prior to
 Screening.

 -  Participant has undergone treatment with probiotics within 6 weeks prior to Screening.

 -  Participant is on active treatment with antibiotics.

 -  Participant has a known fructose intolerance.

 -  Participant is currently on a low fermentable oligo-, di-, mono-saccharides and
 polyols (FODMAP) diet.

 -  Participant has a known diagnosis of gastroparesis.