Opioid induced constipation
Conditions
Interventions
Product Code: BGP-345A
Pharmaceutical Form: Capsule
INN or Proposed INN: Lactobacillus gasseri DSM 27123
Current Sponsor code: BGP-345A
Other descriptive name: LACTOBACILLUS GASSERI
Concentration unit
Sponsors
BIOGAIA PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to the study, male and female subjects will have to fulfil the following criteria (assessment based on the medical examination performed at V0 with a checking at V1): I1. Age over 18 years (limit included), I2. Diagnosed with OIC according to the adapted ROME IV criteria (Mearin F et al, 2016) previously used in clinical evaluation of patients with OIC (Webster LR et al, 2017) and self-reported symptoms assessed by a physician (daily diary check at V1 visit): - Fewer than three (=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: Subjects with the following criteria will be considered as non eligible to the study (assessment based on the medical examination performed at V0 and with a checking at V1): E1. Involvement in any investigational drug or device study within 30 days prior to this study, E2. Unable to withdraw other OIC treatments (any kind of laxative other than provided in the study), E3. History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation upon investigator judgment, E4. Surgery planned within the whole study period, E5. Evidence of active medical diseases affecting bowel transit, E6. Antibiotic treatment intake within the last month prior the study start (V0), E7. Unwilling to withdraw probiotic supplements, yoghurts without supplemented bacteria are permitted, E8. Any history of drug addiction in the past five years, E9. Pregnant or lactating women or intending to become pregnant, E10. Unwilling to maintain food habits and current physical activity for the whole study duration, E11. With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator, E12. Having a lifestyle deemed incompatible with the study according to the investigator including drug and alcohol abuse, E13. Taking part in another clinical trial or being in the exclusion period of a previous clinical trial, E14. Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision, E15. Presenting a psychological or linguistic incapability to sign the informed consent, E16. Impossible to contact in case of emergency. Within 4 weeks following to the exit of the study for failure to comply with one or more of the exclusion criteria listed above, a re-screening could be performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: The primary objective of the study is to demonstrate the efficacy of BGP345A product consumed daily for 4 weeks compared to the control group, by assessing the change in weekly Spontaneous Bowel Movements (SBMs) frequency from the baseline to the last two weeks of the treatment period. ;Secondary Objective: Secondary and safety objectives: The secondary objectives of the study are to evaluate safety by monitoring general health state parameters and incidence of adverse events (AEs). The study will also assess the 4-week consumption of BGP345A by additional efficacy parameters in terms of: •Bowel function •Gastro-intestinal (GI) symptoms •Pain due to constipation •Rescue laxative use The safety objectives of the study are to evaluate general health state parameters and incidence of adverse events (AEs).;Primary end point(s): The frequency and characteristics of stools will be recorded during all the study period (10 weeks, from run-in to end of follow-up period) using the daily diary. For all endpoints, the baseline is defined on the basis of the 2 weeks of the run-in period. Primary endpoint The primary endpoint of the study is the change in the average weekly number of Spontaneous Bowel Movements (SBMs) (expressed in number of stools/week) from baseline to the last two weeks of the treatment period. A SBM is defined as a bowel movement without the use of laxatives in the previous 24 hours as recorded in the daily diary (Webster LR et al, 2017).;Timepoint(s) of evaluation of this end point: Differences will be evaluate.d from baseline (period between V0 and V1 visits) to the last two weeks of the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The frequency and characteristics of stools will be recorded during all the study period (10 weeks, from run-in to end of follow-up period) using the daily diary. For all endpoints, the baseline is defined on the basis of the 2 weeks of the run-in period.Secondary endpoints The secondary endpoints in this research are listed below : - The percentage of responders over the 4-weeks of treatment period defined by subjects reporting an average weekly number of SBMs = 3 in the last two weeks of treatment and an increase of the average weekly number of SBM =1 from baseline; - The change in the average weekly number of BMs, (expressed in number of stools/week) from baseline to: a) the last two weeks of the treatment period, b) each week of the treatment period, c) the last two weeks of the follow-up period; - The change in the average weekly number of CSBMs (expressed in number of stools/week) from baseline to: a) the last two weeks of the treatment period, b) each week of the treatment period, c) the last two weeks of the follow-up period; A CSBM is defined by as a bowel movement without the use of laxatives in the previous 24 hours as recorded in the daily diary and the feeling of complete emptying after bowel movement. - The change in the average weekly number of SBMs (expressed in number of stools/week) from baseline to: a) each week of the treatment period, b) the last two weeks of the follow-up period; - The change in the average weekly number of SBMs (expressed in number of stools/week) with no straining (straining score 1) from baseline to: a) the last two weeks of the treatment period, b) each week of the treatment period, c) the last two weeks of the follow-up period; - The time to first SBM and CSBM (expressed in hours) after the last recorded stool before the randomisation; - The change in the number of days with presence of SBMs (expressed in days/week) from baseline to: a) the last two weeks of the treatment period, b) each week of | — |
Countries
France
Contacts
Public ContactSonia BRINET
BIOFORTIS
Outcome results
None listed