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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Salix Probiotic Blend

About this trial

This is an interventional supportive care trial for Functional Gastrointestinal Disorders focused on measuring Gastrointestinal Disorders, Functional

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Bausch Site 001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Salix Probiotic Blend

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

To assess quality of life prior to and post-treatment, participants will be asked to rate 34 quality of life questions from the sub-categories of dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship, using the following scale: 1=Not at all; 2=Slightly, 3=Moderately; 4=Quite a bit; 5=Extremely. Lower scores=better IBS-related QoL.

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

Participants will be asked to rate GI symptoms of diarrhea, constipation, straining (difficulty) to move bowels, urgency to move bowels (need to rush to the bathroom to avoid an accident), abdominal pain/discomfort, bloating, and distention (abdominal swelling), using a severity scale where 0 represents "none" and 10 represents "severe".

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

Participants will be asked to report the number of days per week (that is, never, 1-2 days, 3-4 days, 5-6 days, or 7 days) they experienced the symptoms of diarrhea, constipation, straining (difficulty) to move their bowels, urgency to move their bowels (need to rush to the bathroom to avoid an accident), abdominal pain/discomfort, bloating, distention (abdominal swelling), ability to fully empty bowels, and excessive passage of gas.

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

Participants will be asked to rate how satisfied they are with the ability to fully empty their bowels on a scale where 0 represents "not satisfied" and 10 represents "very satisfied".

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

Participants will be asked to rate their excessive passage of gas symptoms on the scale where 0 represents "never" and 10 represents "frequently".

Satisfaction with Bowel Habits as Measured by the GI Health Symptom Questionnaire

Participants will be asked to rate how satisfied they are with their bowel habits on a scale where 0 represents "not satisfied" and 10 represents "very satisfied".

Overall Product Satisfaction Evaluation

Participants will be asked to respond to the statement "Taking everything into consideration, would you say you are satisfied with this probiotic supplement, overall?" with a response of "Yes", "No", or "Do Not Know".

Change From Baseline in Intestinal Fatty-Acid Binding Protein (I-FABP) Levels (Intestinal Integrity Serum Marker) at Day 30

Intestinal permeability assessments will be conducted through the evaluation of serum I-FABP levels in a blood sample collected from participants at Baseline and Day 30.

Full Information

NCT ID

NCT04155801

First Posted

November 5, 2019

Last Updated

April 23, 2020

Sponsor

Bausch Health Americas, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04155801

Brief Title

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

Official Title

An Open-Label, Multicenter Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Subjects With Functional Gastrointestinal Disturbances

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

October 11, 2019 (Actual)

Primary Completion Date

February 14, 2020 (Actual)

Study Completion Date

February 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch Health Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Gastrointestinal Disorders

Keywords

Gastrointestinal Disorders, Functional

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

188 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Salix Probiotic Blend

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Salix Probiotic Blend

Intervention Description

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]®).

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Day 42 (End of Study [EOS] Visit)

Secondary Outcome Measure Information:

Title

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

Description

To assess quality of life prior to and post-treatment, participants will be asked to rate 34 quality of life questions from the sub-categories of dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship, using the following scale: 1=Not at all; 2=Slightly, 3=Moderately; 4=Quite a bit; 5=Extremely. Lower scores=better IBS-related QoL.

Time Frame