Smoking CessationPhase 2NCT02492022
Efficacy of 2 Probiotics During Nicotine Replacement Therapy on Withdrawal Symptoms Associated With Smoking Cessation
A Phase 2 study testing Probiotic L008-1 and Probiotic L008-2 in people with Smoking Cessation, run by Lallemand Health Solutions at 1 site in Canada.
Trial summary
Quitting smoking is a big decision, a decision to achieve better health. Trying to quit smoking can be stressful. The prospect of dealing with withdrawal symptoms, fear or failure to change the routine, can also be sources of stress. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Probiotic L008-1 and Probiotic L008-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Jan 2016
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Moderate or heavy smokers as defined by:
- a score at the Fargerström Test for Nicotine Dependence ≥ 5, and who smoke more than 10 cigarettes per day.
- Participants willing to stop smoking, corresponding to a score of 6 or 7 to the Motivation To Stop Scale. The MTSS is a one-item questionnaire with 7 possible choices, from 1 (lowest level of motivation to stop smoking) to level 7 (highest level of motivation to stop smoking).
- Participants need to be able to understand and consent to, and willing to comply with study procedures.
- Willingness to discontinue consumption of probiotic supplements and food containing added probiotics or and/or prebiotics (e.g. yoghourts, with live, active cultures or supplements).
Who cannot join
- Positive pregnancy test in women of child-bearing potential
- Pregnant or breast-feeding or planning on becoming pregnant.
- Women of child-bearing potential not using effective contraception, wich include :
- Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants; Intrauterine devices (IUD) or Intrauterine system (IUS); Tubal ligation; Vasectomy of partner; Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap)
- Use of another investigational product within 3 months of the screening visit.
- Currently being treated for any known illnesses or conditions that may impact perceived health such as HIV/AIDS, immune modulating diseases (autoimmune, hepatitis, cancer, etc.), diabetes, kidney or liver disease, gastrointestinal diseases (e.g. gastric ulcers, Crohn's, ulcerative colitis, etc.)
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- Suffered or suffering from heart attack, angina, heart arrhythmias, stroke, heart disease, thyroid problems, and diabetes requiring insulin.
- Participants with eczema, psoriasis, dermatitis or urticaria.
- Participants with soy or milk allergy.
- Participants with allergies to adhesive tape or bandages.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomized Placebo-controlled Trial Assessing the Effectiveness of Two Probiotic Products During Nicotine Replacement Therapy for Managing Withdrawal Symptoms Associated With Smoking Cessation
Quitting smoking is a big decision, a decision to achieve better health. Trying to quit smoking can be stressful. The prospect of dealing with withdrawal symptoms, fear or failure to change the routine, can also be sources of stress.
Withdrawal from nicotine is characterized by symptoms that include anxiety, irritability, hunger and cravings for more tobacco. Nicotine creates a dependency so that the body develops a need for a certain level of nicotine at all times. Unless that level is maintained symptoms of withdrawal appear.
Read more
For tobacco users trying to quit, symptoms of withdrawal from nicotine are unpleasant and stressful, but they are temporary.
Research has demonstrated the relative effectiveness of pharmacotherapy treatments in smoking cessation but no studies have examined the effects of the probiotics on the withdrawal symptoms associated with the tobacco cessation during nicotine replacement therapy (NRT).
The purpose of this study is to assess the effectiveness of two probiotic products during NRT for managing withdrawal symptoms associated with smoking cessation.
- Conditions
- Smoking Cessation
- Being tested
- Probiotic L008-1, Probiotic L008-2, Placebo
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic L008-1Dietary supplement
Dosing regimen of 2 capsules daily, once per day, for 14 weeks
Probiotic L008-2Dietary supplement
Dosing regimen of 2 capsules daily, once per day, for 14 weeks
PlaceboOther
Dosing regimen of 2 capsules daily, once per day, for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic L008-1 | Experimental | Encapsuled combinaison of 2 probiotics Receives: Dietary Supplement: Probiotic L008-1 |
| Probiotic L008-2 | Experimental | Encapsuled combinaison of 2 probiotics Receives: Dietary Supplement: Probiotic L008-2 |
| Placebo | Placebo comparator | Encapsuled non active ingredients Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the withdrawal symptoms assessed by the Mood and Physical Symptoms Scale (MPSS)
The MPSS(M) score, corresponding to the sum of the 7 items of the MPSS mood subscale, will be compared between groups, daily between week 2 and 4 (first 2 weeks of tobacco abstinence) and week 12 and 14 (first 2 weeks after the end of NRT), and weekly for the other weeks. For weekly comparisons, an average of daily scores will be done for the respective weeks.
The score will also be compared in time within groups, using the baseline ratings as covariates
Measured: MPSS will be self-administered daily during 16 weeks
Secondary outcomes (12)
Evolution of anxiety and depression assessed by the HADS questionnaire
Measured: measured 6 times up to 16 weeks
Evolution of nicotine addiction assessed by the Fargerström Test for Nicotine Dependence
Measured: measured 3 times up to 16 weeks
Difference in tobacco abstinence between arms, determined by levels of exhaled CO and salivary cotinine dosage
Measured: measured 6 times up to 16 weeks
Evolution of body weight
Measured: measured 6 times up to 16 weeks
Evolution of food cravings
Assessed by the Food Cravings Self-Questionnaire
Measured: self-reported, weekly, up to 16 weeks
Tolerance of the probiotics against placebo
Assessed by the reporting and the comparison of the Adverse events occurred in the different arms
Measured: up to 16 weeks
Effect of probiotics and smoking cessation on daily bowel movement frequency and consistency, assessed by the Bristol Stool Scale
Measured: Self-reported, daily during 16 weeks
Changes in the microbiome composition of participants in the probiotic groups compared to placebo
Assessed by the analyse of the stool samples collected
Measured: measured 2 times up to 16 weeks
Recovery of the probiotic strains in the stools
Assessed by the change in the probiotic strains concentration in the stools samples collected in all three arms.
Measured: measrured 2 times up to 16 weeks
Evolution of nicotine addiction assessed by a visual analog scale
Measured: measured 6 times up to 16 weeks
Comparison of MPSS(Craving or C), MPSS(Physical symptoms or P), and MPSS total scores (corresponding to the sum of MPSS(M), MPSS(C) and MPSS(M) scores)
daily comparison between week 2 and 4 (first 2 weeks of tobacco abstinence) and week 12 and 14 (first 2 weeks after the end of NRT), and weekly for the other weeks. The scores will be also compared in time within groups, using the baseline ratings as covariates. For weekly comparisons, an average of daily scores will be done for the respective weeks
Measured: MPSS will be self-administered daily during 16 weeks
Correlation between CO levels in exhaled air and salivary cotinine levels
Measured: measured 6 times up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedQualis, Q & T Research
- Responsible party
- Sponsor
- Investigators
- Luc Larrivée, MD, Principal investigator, Q & T Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492022
- Sponsor's protocol ID
- Smoking Cessation
- Status last verified
- Feb 2016
- First submitted
- 17 Jun 2015
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Placebo-controlled Trial Assessing the Effectiveness of Two Probiotic Products During Nicotine Replacement Therapy for Managing Withdrawal Symptoms Associated With Smoking Cessation
- ClinicalTrials.gov ID
- NCT02492022
- Acronym / sponsor ID
- Smoking Cessation
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- MedQualis, Q & T Research
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 8 Jul 2015 (estimated)
- 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.
Quitting smoking is a big decision, a decision to achieve better health. Trying to quit smoking can be stressful. The prospect of dealing with withdrawal symptoms, fear or failure to change the routine, can also be sources of stress.
Withdrawal from nicotine is characterized by symptoms that include anxiety, irritability, hunger and cravings for more tobacco. Nicotine creates a dependency so that the body develops a need for a certain level of nicotine at all times. Unless that level is maintained symptoms of withdrawal appear.
For tobacco users trying to quit, symptoms of withdrawal from nicotine are unpleasant and stressful, but they are temporary.
Research has demonstrated the relative effectiveness of pharmacotherapy treatments in smoking cessation but no studies have examined the effects of the probiotics on the withdrawal symptoms associated with the tobacco cessation during nicotine replacement therapy (NRT).
The purpose of this study is to assess the effectiveness of two probiotic products during NRT for managing withdrawal symptoms associated with smoking cessation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic L008-1 | Experimental | Dietary Supplement: Probiotic L008-1Encapsuled combinaison of 2 probiotics |
| Probiotic L008-2 | Experimental | Dietary Supplement: Probiotic L008-2Encapsuled combinaison of 2 probiotics |
| Placebo | Placebo comparator | Other: PlaceboEncapsuled non active ingredients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18-65 years
- Moderate or heavy smokers as defined by:
- a score at the Fargerström Test for Nicotine Dependence ≥ 5, and who smoke more than 10 cigarettes per day.
- Participants willing to stop smoking, corresponding to a score of 6 or 7 to the Motivation To Stop Scale. The MTSS is a one-item questionnaire with 7 possible choices, from 1 (lowest level of motivation to stop smoking) to level 7 (highest level of motivation to stop smoking).
- Participants need to be able to understand and consent to, and willing to comply with study procedures.
Key exclusion criteria (10 listed)
- Positive pregnancy test in women of child-bearing potential
- Pregnant or breast-feeding or planning on becoming pregnant.
- Women of child-bearing potential not using effective contraception, wich include :
- Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants; Intrauterine devices (IUD) or Intrauterine system (IUS); Tubal ligation; Vasectomy of partner; Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap)
- Use of another investigational product within 3 months of the screening visit.
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 |
|---|---|---|
| Probiotic L008-1Dosing regimen of 2 capsules daily, once per day, for 14 weeks | Dietary supplement | Probiotic L008-1 |
| Probiotic L008-2Dosing regimen of 2 capsules daily, once per day, for 14 weeks | Dietary supplement | Probiotic L008-2 |
| PlaceboDosing regimen of 2 capsules daily, once per day, for 14 weeks | Other | Placebo |
Primary outcome
Evolution of the withdrawal symptoms assessed by the Mood and Physical Symptoms Scale (MPSS)
Time frame: MPSS will be self-administered daily during 16 weeks
The MPSS(M) score, corresponding to the sum of the 7 items of the MPSS mood subscale, will be compared between groups, daily between week 2 and 4 (first 2 weeks of tobacco abstinence) and week 12 and 14 (first 2 weeks after the end of NRT), and weekly for the other weeks. For weekly comparisons, an average of daily scores will be done for the respective weeks. The score will also be compared in time within groups, using the baseline ratings as covariates
12 secondary outcomes
Evolution of anxiety and depression assessed by the HADS questionnaire
Time frame: measured 6 times up to 16 weeks
Evolution of nicotine addiction assessed by the Fargerström Test for Nicotine Dependence
Time frame: measured 3 times up to 16 weeks
Difference in tobacco abstinence between arms, determined by levels of exhaled CO and salivary cotinine dosage
Time frame: measured 6 times up to 16 weeks
Evolution of body weight
Time frame: measured 6 times up to 16 weeks
Evolution of food cravings
Time frame: self-reported, weekly, up to 16 weeks
Tolerance of the probiotics against placebo
Time frame: up to 16 weeks
Effect of probiotics and smoking cessation on daily bowel movement frequency and consistency, assessed by the Bristol Stool Scale
Time frame: Self-reported, daily during 16 weeks
Changes in the microbiome composition of participants in the probiotic groups compared to placebo
Time frame: measured 2 times up to 16 weeks
Recovery of the probiotic strains in the stools
Time frame: measrured 2 times up to 16 weeks
Evolution of nicotine addiction assessed by a visual analog scale
Time frame: measured 6 times up to 16 weeks
Comparison of MPSS(Craving or C), MPSS(Physical symptoms or P), and MPSS total scores (corresponding to the sum of MPSS(M), MPSS(C) and MPSS(M) scores)
Time frame: MPSS will be self-administered daily during 16 weeks
Correlation between CO levels in exhaled air and salivary cotinine levels
Time frame: measured 6 times up to 16 weeks
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 18 Feb 2016.
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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.
Luc Larrivée, MD principal investigator
Q & T Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic L008-1 and Probiotic L008-2 in people with Smoking Cessation, run by Lallemand Health Solutions at 1 site in Canada.
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 6 inclusion and 10 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 18 Feb 2016. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evolution of the withdrawal symptoms assessed by the Mood and Physical Symptoms Scale (MPSS) (time frame: MPSS will be self-administered daily during 16 weeks). 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 18 Feb 2016.