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

NCT ID: NCT04155801

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-11
• Study Completion Date: 2020-02-14

Brief Summary

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.

Conditions

Functional Gastrointestinal Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Salix Probiotic Blend

Participants will receive a Salix Probiotic Blend capsule orally once a day for 30 days.

Group Type: EXPERIMENTAL

Salix Probiotic Blend

Intervention Type: DIETARY_SUPPLEMENT

Oral capsule. The probiotic strains comprise the Salix Probiotic Blend include 3 strains of Bifidobacterium lactis (Bl-04®, Bi-07®, HN019) and 2 strains of lactobacillus (Lactobacillus acidophilus \[NCFM\]® and Lactobacillus paracasei \[Lpc-37\]®).

Interventions

Salix Probiotic Blend

Oral capsule. The probiotic strains comprise the Salix Probiotic Blend include 3 strains of Bifidobacterium lactis (Bl-04®, Bi-07®, HN019) and 2 strains of lactobacillus (Lactobacillus acidophilus \[NCFM\]® and Lactobacillus paracasei \[Lpc-37\]®).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsey Mathew

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

Bausch Site 001

San Antonio, Texas, United States

Countries

United States

Other Identifiers

PBGD1001

Identifier Type: -

Identifier Source: org_study_id