A Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Participants With Functional Gastrointestinal Disturbances

Bausch Health

Status

Completed

Conditions

Functional Gastrointestinal Disorders

Treatments

Dietary Supplement: Salix Probiotic Blend

Study type

Interventional

Funder types

Industry

Identifiers

NCT04155801

PBGD1001

Details and patient eligibility

About

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.

Enrollment

188 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.