An interventional study of Salix Probiotic Blend in Functional Gastrointestinal Disorders, sponsored by Bausch Health Americas, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by Bausch Health Americas, Inc. · Not applicable, Interventional, and Supportive care
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.
628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.
This study's enrollment of 188 is above the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
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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:
Exclusion Criteria:
Participants will receive a Salix Probiotic Blend capsule orally once a day for 30 days.
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 \[Lpc-37\]®).
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.
Time frame: Day 42 (End of Study [EOS] Visit)
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.
Time frame: 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
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".
Time frame: Baseline up to Day 42 (EOS Visit)
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.
Time frame: Baseline up to Day 42 (EOS Visit)
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".
Time frame: Baseline up to Day 42 (EOS Visit)
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".
Time frame: Baseline up to Day 42 (EOS Visit)
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".
Time frame: Baseline up to Day 42 (EOS Visit)
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".
Time frame: Day 30
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.
Time frame: Day 30
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Bausch Health Americas, Inc.