Functional Gastrointestinal DisordersNCT04155801
A Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Participants With Functional Gastrointestinal Disturbances
A study testing Salix Probiotic Blend in people with Functional Gastrointestinal Disorders, run by Bausch Health Americas, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Salix Probiotic Blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2019to 14 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Multicenter Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Subjects With Functional Gastrointestinal Disturbances
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
- Being tested
- Salix Probiotic Blend
- Keywords
- Gastrointestinal Disorders, Functional
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salix Probiotic BlendDietary 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]®).
| Study group | Role | What they receive |
|---|---|---|
| Salix Probiotic Blend | Experimental | Participants will receive a Salix Probiotic Blend capsule orally once a day for 30 days. Receives: Dietary Supplement: Salix Probiotic Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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".
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start11 Oct 2019
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lindsey Mathew, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155801
- Sponsor's protocol ID
- PBGD1001
- Status last verified
- Apr 2020
- First submitted
- 5 Nov 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Subjects With Functional Gastrointestinal Disturbances
- ClinicalTrials.gov ID
- NCT04155801
- Acronym / sponsor ID
- PBGD1001
- Conditions
- Functional Gastrointestinal Disorders
- Keywords
- Gastrointestinal Disorders, Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salix Probiotic Blend | Experimental | Dietary Supplement: Salix Probiotic BlendParticipants will receive a Salix Probiotic Blend capsule orally once a day for 30 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salix Probiotic BlendOral 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]®). | Dietary supplement | Salix Probiotic Blend |
Primary outcome
Percentage of Participants with a Positive Response to the Product Satisfaction Question
Time frame: Day 42 (End of Study [EOS] Visit)
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.
8 secondary outcomes
Measures of Quality of Life Using the Irritable Bowel Syndrome Quality of Life (IBS-QOL) Questionnaire
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
Time frame: Baseline up to Day 42 (EOS Visit)
Frequency of GI Symptoms as Measured by the GI Health Symptom Questionnaire
Time frame: Baseline up to Day 42 (EOS Visit)
Satisfaction with Ability to Fully Empty Bowels as Measured by the GI Health Symptom Questionnaire
Time frame: Baseline up to Day 42 (EOS Visit)
Passage of Gas Symptoms as Measured by the GI Health Symptom Questionnaire
Time frame: Baseline up to Day 42 (EOS Visit)
Satisfaction with Bowel Habits as Measured by the GI Health Symptom Questionnaire
Time frame: Baseline up to Day 42 (EOS Visit)
Overall Product Satisfaction Evaluation
Time frame: Day 30
Change From Baseline in Intestinal Fatty-Acid Binding Protein (I-FABP) Levels (Intestinal Integrity Serum Marker) at Day 30
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey Mathew study director
Bausch Health Americas, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salix Probiotic Blend in people with Functional Gastrointestinal Disorders, run by Bausch Health Americas, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with a Positive Response to the Product Satisfaction Question (time frame: Day 42 (End of Study [EOS] Visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.