Clinical trial NCT04155801: 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
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Keywords: Gastrointestinal Disorders, Functional
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-07
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Percentage of Participants with a Positive Response to the Product Satisfaction Question
timeFrame: Day 42 (End of Study [EOS] Visit)
Secondary outcomes:
measure: Measures of Quality of Life Using the Irritable Bowel Syndrome Quality of Life (IBS-QOL) Questionnaire
timeFrame: Baseline up to Day 42 (EOS Visit)
measure: Severity of Diarrhea, Constipation, Straining, Urgency, Abdominal Pain/Discomfort, Bloating, and Distention as Measured by the Gastrointestinal (GI) Health Symptom Questionnaire
timeFrame: Baseline up to Day 42 (EOS Visit)
measure: Frequency of GI Symptoms as Measured by the GI Health Symptom Questionnaire
timeFrame: Baseline up to Day 42 (EOS Visit)
measure: Satisfaction with Ability to Fully Empty Bowels as Measured by the GI Health Symptom Questionnaire
timeFrame: Baseline up to Day 42 (EOS Visit)
measure: Passage of Gas Symptoms as Measured by the GI Health Symptom Questionnaire
timeFrame: Baseline up to Day 42 (EOS Visit)
measure: Satisfaction with Bowel Habits as Measured by the GI Health Symptom Questionnaire
timeFrame: Baseline up to Day 42 (EOS Visit)
measure: Overall Product Satisfaction Evaluation
timeFrame: Day 30
measure: Change From Baseline in Intestinal Fatty-Acid Binding Protein (I-FABP) Levels (Intestinal Integrity Serum Marker) at Day 30
timeFrame: Day 30
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Bausch Site 001
state: Texas
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Lindsey Mathew
role: STUDY_DIRECTOR
References: