Back to resultsEfficacy of 2 Probiotics During Nicotine Replacement Therapy on Withdrawal Symptoms Associated With Smoking Cessation
Primary Purpose
Smoking Cessation
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Probiotic L008-1
Probiotic L008-2
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Smoking Cessation
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.)
- 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.
Sites / Locations
- Q & T Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Probiotic L008-1
Probiotic L008-2
Placebo
Arm Description
Encapsuled combinaison of 2 probiotics
Encapsuled combinaison of 2 probiotics
Encapsuled non active ingredients
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Evolution of anxiety and depression assessed by the HADS questionnaire
Evolution of nicotine addiction assessed by the Fargerström Test for Nicotine Dependence
Difference in tobacco abstinence between arms, determined by levels of exhaled CO and salivary cotinine dosage
Evolution of body weight
Evolution of food cravings
Assessed by the Food Cravings Self-Questionnaire
Tolerance of the probiotics against placebo
Assessed by the reporting and the comparison of the Adverse events occurred in the different arms
Effect of probiotics and smoking cessation on daily bowel movement frequency and consistency, assessed by the Bristol Stool Scale
Changes in the microbiome composition of participants in the probiotic groups compared to placebo
Assessed by the analyse of the stool samples collected
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.
Evolution of nicotine addiction assessed by a visual analog scale
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
Correlation between CO levels in exhaled air and salivary cotinine levels
Full Information
NCT ID
NCT02492022
First Posted
June 17, 2015
Last Updated
February 16, 2016
Sponsor
Lallemand Health Solutions
Collaborators
MedQualis, Q & T Research
1. Study Identification
Unique Protocol Identification Number
NCT02492022
Brief Title
Efficacy of 2 Probiotics During Nicotine Replacement Therapy on Withdrawal Symptoms Associated With Smoking Cessation
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lallemand Health Solutions
Collaborators
MedQualis, Q & T Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic L008-1
Arm Type
Experimental
Arm Description
Encapsuled combinaison of 2 probiotics
Arm Title
Probiotic L008-2
Arm Type
Experimental
Arm Description
Encapsuled combinaison of 2 probiotics
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Encapsuled non active ingredients
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic L008-1
Intervention Description
Dosing regimen of 2 capsules daily, once per day, for 14 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic L008-2
Intervention Description
Dosing regimen of 2 capsules daily, once per day, for 14 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Dosing regimen of 2 capsules daily, once per day, for 14 weeks
Primary Outcome Measure Information:
Title
Evolution of the withdrawal symptoms assessed by the Mood and Physical Symptoms Scale (MPSS)
Description
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
Time Frame
MPSS will be self-administered daily during 16 weeks
Secondary Outcome Measure Information:
Title
Evolution of anxiety and depression assessed by the HADS questionnaire
Time Frame
measured 6 times up to 16 weeks
Title
Evolution of nicotine addiction assessed by the Fargerström Test for Nicotine Dependence
Time Frame
measured 3 times up to 16 weeks
Title
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
Title
Evolution of body weight
Time Frame
measured 6 times up to 16 weeks
Title
Evolution of food cravings
Description
Assessed by the Food Cravings Self-Questionnaire
Time Frame
self-reported, weekly, up to 16 weeks
Title
Tolerance of the probiotics against placebo
Description
Assessed by the reporting and the comparison of the Adverse events occurred in the different arms
Time Frame
up to 16 weeks
Title
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
Title
Changes in the microbiome composition of participants in the probiotic groups compared to placebo
Description
Assessed by the analyse of the stool samples collected
Time Frame
measured 2 times up to 16 weeks
Title
Recovery of the probiotic strains in the stools
Description
Assessed by the change in the probiotic strains concentration in the stools samples collected in all three arms.
Time Frame
measrured 2 times up to 16 weeks
Title
Evolution of nicotine addiction assessed by a visual analog scale
Time Frame
measured 6 times up to 16 weeks
Title
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)
Description
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
Time Frame
MPSS will be self-administered daily during 16 weeks
Title
Correlation between CO levels in exhaled air and salivary cotinine levels
Time Frame
measured 6 times up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Larrivée, MD
Organizational Affiliation
Q & T Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Q & T Research
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J2G2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy of 2 Probiotics During Nicotine Replacement Therapy on Withdrawal Symptoms Associated With Smoking Cessation
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