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

NCT04155801 | Completed

• 1 other identifier: PBGD1001
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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

Keywords

Gastrointestinal Disorders, Functional

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with a Positive Response to the Product Satisfaction Question

  Participants will be asked to consider how they felt in the past week in regard to their gastrointestinal well-being and symptoms of abdominal discomfort or pain, bloating, or distension, gas, and altered bowel habit, and to respond to the following overall product satisfaction question: "Compared to the way you felt before beginning the supplement, how strongly do you feel you have had improvement of your overall gastrointestinal well-being?". Responses will be assessed on a Likert 6-point scale. Potential responses will include 1=strongly agree, 2=disagree, 3=slightly disagree, 4=slightly agree, 5=agree, and 6=strongly agree. The percentage of participants with the response of 4=slightly agree, 5=agree, and 6=strongly agree will be reported.

  Day 42 (End of Study [EOS] Visit)

Secondary Outcomes (8)

• Measures of Quality of Life Using the Irritable Bowel Syndrome Quality of Life (IBS-QOL) Questionnaire

  Baseline up to Day 42 (EOS Visit)

• Severity of Diarrhea, Constipation, Straining, Urgency, Abdominal Pain/Discomfort, Bloating, and Distention as Measured by the Gastrointestinal (GI) Health Symptom Questionnaire

  Baseline up to Day 42 (EOS Visit)

• Frequency of GI Symptoms as Measured by the GI Health Symptom Questionnaire

  Baseline up to Day 42 (EOS Visit)

• Satisfaction with Ability to Fully Empty Bowels as Measured by the GI Health Symptom Questionnaire

  Baseline up to Day 42 (EOS Visit)

• Passage of Gas Symptoms as Measured by the GI Health Symptom Questionnaire

  Baseline up to Day 42 (EOS Visit)

Study Arms (1)

Salix Probiotic Blend

EXPERIMENTAL

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

Dietary Supplement: Salix Probiotic Blend

Interventions

Salix Probiotic Blend 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 \[Lpc-37\]®).

Salix Probiotic Blend

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Bausch Site 001

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Lindsey Mathew

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: October 11, 2019
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)