Opioid-Induced ConstipationPhase 2OIC1NCT05133076
Safety and Preliminary Efficacy of BGP345A in Constipation Due to Opioid-based Medications
A Phase 2 study testing Lactobacillus gasseri BGP345A in people with Opioid-Induced Constipation, run by BioGaia Pharma AB at 4 sites in France.
Trial summary
The purpose of this study is to assess safety and preliminary efficacy of BGP345A in patients with constipation due to the use of opioid-based medications for the management of chronic non cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Induced Constipation
- What is being tested?
- Lactobacillus gasseri BGP345A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Jan 2022to 12 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (<3) spontaneous bowel movements (SBMs) per week. A SBM is defined as a bowel movement without the use of laxatives in the previous 24 hours as recorded in the daily diary.
- And one or more of the following symptoms in at least 25% of bowel movements: straining, feeling of incomplete evacuation, and/or hard/small stools, defined as Bristol Stool Scale (BSS) score lower than 3 (<3).
- I3. With chronic non-cancer pain since at least three months, including the following indications but not limited to: back-pain, rheumatisms and post-operative pain,
- I4. Patients received opioids for chronic analgesia (intended treatment ≥6 Weeks) for 1 week or more prior to study start and a stable regimen of opioids for 3 or more days before study entry (V0 visit) and during the whole study ,
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- I5. Subjects must be willing to discontinue laxative use at screening and only use the rescue laxatives permitted throughout the study duration,
- I6. For women:
- Non menopausal with the same reliable contraception since at least 2 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel, any oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, surgical intervention (bilateral tubal ligation or ovariectomy or hysterectomy), ESSURE system),
- Menopausal without or with hormone replacement therapy,
- I7. Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
- I8. Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
- I9. Affiliated with a social security scheme.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU d'Amiens
Amiens, 80054
Groupe hospitalier Saint-Joseph
Paris, Paris, 75014
CHU DE NANTES (Hôpital Nord Laennec)
Saint-Herblain, 44800
CH de Valenciennes
Valenciennes, 59322
About this study
Official title: A Randomized Placebo-controlled Study to Assess Safety and Preliminary Efficacy of BGP345A in Patients With Constipation Due to the Use of Opioid-based Medications for the Management of Chronic Non Cancer Pain
The purpose of this study is to assess safety and preliminary efficacy of BGP345A in patients with constipation due to the use of opioid-based medications for the management of chronic non cancer pain.
- Conditions
- Opioid-Induced Constipation
- Being tested
- Lactobacillus gasseri BGP345A, Placebo
- Medical subject headings
- Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus gasseri BGP345ABiological
Also called BGP345A
Active and placebo capsules for oral use
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | Not described Receives: Biological: Lactobacillus gasseri BGP345A |
| Placebo arm | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the average weekly number of Spontaneous Bowel Movements (SBMs) (expressed in number of stools/week)
A SBM (Spontaneous Bowel Movement) 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).
Measured: Over the 4 week treatment period
Secondary outcomes (21)
Percentage of responders over the 4-weeks of treatment period defined by subjects reporting an average weekly number of SBMs ≥ 3 and an increase of the average weekly number of SBM ≥1 from baseline
SBM responders
Measured: Average over the last two weeks of treatment
Change in the average weekly number of BMs (Bowel Movements)
BM (Bowel Movements) expressed in number of stools/week
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the average weekly number of CSBMs (Complete Spontaneous Bowel Movement)
CSBMs (Complete Spontaneous Bowel Movement) expressed in number of stools/week 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.
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the average weekly number of SBMs
SBMs expressed in number of stools/week
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the average weekly number of SBMs with no straining (straining score 1)
SBMs expressed in number of stools/week
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Time to first SBM and CSBM after the last recorded stool before the randomisation
Expressed in hours
Measured: Over 4 week treatment period
Change in the number of days with presence of SBMs
SBMs expressed in days/week
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the number of days with presence of CSBMs
CSBMs expressed in days/week
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the average weekly number of SBMs rated 3 or 4 on the BSS (Bristol Stool Scale)
Expressed in stools/week
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change of stool consistency assessed by the BSS (Bristol Stool Scale)
Expressed in arbitrary units/stool from 1-7.
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change of the overall BFI (Bowel Function Index) score
Expressed in arbitrary units, range 0-100
Measured: Over 4 week treatment period
Change in the average daily abdominal bloating score
Expressed in arbitrary units/day (this score will be assessed daily for the past 24hours and could range from 0 to 4, where 0 = absent or no bloating, 1 = mild, 2 = moderate, 3= severe, and 4 =very severe bloating)
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the average daily abdominal discomfort score
Expressed in arbitrary units/day (this score will be assessed daily for the past 24hours and could range from 0 to 4, where 0 = no abdominal discomfort, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe discomfort)
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in average daily pain at defecation assessed by the Visual Analogic Scale for pain at defecation (VAS)
Expressed in arbitrary units/day with stool, range 0-100
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the weekly frequency of rescue laxative use assessed by the daily diary
expressed in average of days/week
Measured: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Frequency of rescue laxative use assessed by the daily diary.
Expressed in number of laxative uses
Measured: Over the 4 week treatment period
General health state measuring vital parameters assessed - Body weight
Body weight (kg)
Measured: Through study completion, 10 weeks
General health state measuring vital parameters assessed- Diastolic Blood Pressure
Diastolic Blood Pressure (mmHg)
Measured: Through study completion, 10 weeks
General health state measuring vital parameters assessed- Systolic Blood Pressure
Systolic Blood Pressure (mmHg)
Measured: Through study completion, 10 weeks
General health state measuring vital parameters assessed- Vital signs
Vital signs (BPM)
Measured: Through study completion, 10 weeks
the frequency of adverse events (AE), serious adverse events (SAE), Treatment-Emergent Adverse events (TEAE), Serious treatment-emergent adverse events (STEAE)
Frequency and nature of events
Measured: Through study completion, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start20 Jan 2022
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Induced ConstipationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Petra J Lierud, Study director, BioGaia Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133076
- Sponsor's protocol ID
- PEC19156
- Acronym
- OIC1
- Status last verified
- Sep 2023
- First submitted
- 26 Oct 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Study to Assess Safety and Preliminary Efficacy of BGP345A in Patients With Constipation Due to the Use of Opioid-based Medications for the Management of Chronic Non Cancer Pain
- ClinicalTrials.gov ID
- NCT05133076
- Acronym / sponsor ID
- OIC1 / PEC19156
- Conditions
- Opioid-Induced Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BioGaia Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 24 Nov 2021 (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 purpose of this study is to assess safety and preliminary efficacy of BGP345A in patients with constipation due to the use of opioid-based medications for the management of chronic non cancer pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Biological: Lactobacillus gasseri BGP345A |
| Placebo arm | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 (<3) spontaneous bowel movements (SBMs) per week. A SBM is defined as a bowel movement without the use of laxatives in the previous 24 hours as recorded in the daily diary.
- And one or more of the following symptoms in at least 25% of bowel movements: straining, feeling of incomplete evacuation, and/or hard/small stools, defined as Bristol Stool Scale (BSS) score lower than 3 (<3).
- I3. With chronic non-cancer pain since at least three months, including the following indications but not limited to: back-pain, rheumatisms and post-operative pain,
Key exclusion criteria (16 listed)
- 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,
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 |
|---|---|---|
| Lactobacillus gasseri BGP345AAlso: BGP345AActive and placebo capsules for oral use | Biological | Active arm |
| PlaceboPlacebo | Biological | Placebo arm |
Primary outcome
Change in the average weekly number of Spontaneous Bowel Movements (SBMs) (expressed in number of stools/week)
Time frame: Over the 4 week treatment period
A SBM (Spontaneous Bowel Movement) 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).
21 secondary outcomes
Percentage of responders over the 4-weeks of treatment period defined by subjects reporting an average weekly number of SBMs ≥ 3 and an increase of the average weekly number of SBM ≥1 from baseline
Time frame: Average over the last two weeks of treatment
Change in the average weekly number of BMs (Bowel Movements)
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the average weekly number of CSBMs (Complete Spontaneous Bowel Movement)
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the average weekly number of SBMs
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the average weekly number of SBMs with no straining (straining score 1)
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Time to first SBM and CSBM after the last recorded stool before the randomisation
Time frame: Over 4 week treatment period
Change in the number of days with presence of SBMs
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the number of days with presence of CSBMs
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the average weekly number of SBMs rated 3 or 4 on the BSS (Bristol Stool Scale)
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change of stool consistency assessed by the BSS (Bristol Stool Scale)
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change of the overall BFI (Bowel Function Index) score
Time frame: Over 4 week treatment period
Change in the average daily abdominal bloating score
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the average daily abdominal discomfort score
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in average daily pain at defecation assessed by the Visual Analogic Scale for pain at defecation (VAS)
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Change in the weekly frequency of rescue laxative use assessed by the daily diary
Time frame: Over 4 week treatment period; during each week of the treatment period; and up to 8 weeks at study completion.
Frequency of rescue laxative use assessed by the daily diary.
Time frame: Over the 4 week treatment period
General health state measuring vital parameters assessed - Body weight
Time frame: Through study completion, 10 weeks
General health state measuring vital parameters assessed- Diastolic Blood Pressure
Time frame: Through study completion, 10 weeks
General health state measuring vital parameters assessed- Systolic Blood Pressure
Time frame: Through study completion, 10 weeks
General health state measuring vital parameters assessed- Vital signs
Time frame: Through study completion, 10 weeks
the frequency of adverse events (AE), serious adverse events (SAE), Treatment-Emergent Adverse events (TEAE), Serious treatment-emergent adverse events (STEAE)
Time frame: Through study completion, 10 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 26 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Petra J Lierud study director
BioGaia Pharma
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus gasseri BGP345A in people with Opioid-Induced Constipation, run by BioGaia Pharma AB at 4 sites in France.
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 13 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Change in the average weekly number of Spontaneous Bowel Movements (SBMs) (expressed in number of stools/week) (time frame: Over the 4 week treatment period). 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 26 Jun 2025.