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

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155801
• Other study ID #: PBGD1001
• Status: Completed
• Phase: N/A
• Start date: October 11, 2019
• Est. completion date: February 14, 2020

Study information

• Verified date: April 2020
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: February 14, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Dietary Supplement:
• 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]®).

Locations

Country	Name	City	State
United States	Bausch Site 001	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline up to Day 42 (EOS Visit)
Secondary	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".	Baseline up to Day 42 (EOS Visit)
Secondary	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.	Baseline up to Day 42 (EOS Visit)
Secondary	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".	Baseline up to Day 42 (EOS Visit)
Secondary	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".	Baseline up to Day 42 (EOS Visit)
Secondary	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".	Baseline up to Day 42 (EOS Visit)
Secondary	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".	Day 30
Secondary	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.	Day 30