Assessing the safety and effectiveness of BGP345A for opioid-induced constipation

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

This study is testing a new treatment called BGP345A to see if it can help people with constipation caused by opioid pain medications feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BioGaia Pharma AB (Industry-sponsored)
• Locations: 3 sites (Amiens and 2 other locations)
• Trial ID: NCT05133076 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and preliminary efficacy of BGP345A, a strain of Lactobacillus gasseri, in patients suffering from constipation caused by opioid medications used for chronic non-cancer pain management. Participants will be monitored for their bowel movement frequency and associated symptoms to determine the treatment's effectiveness. The study involves a comparison between the active treatment and a placebo to assess any significant differences in outcomes. It aims to provide insights into a potential new therapeutic option for managing opioid-induced constipation.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old diagnosed with opioid-induced constipation and experiencing chronic non-cancer pain.

Not a fit: Patients who do not have opioid-induced constipation or those with other underlying gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve bowel function and quality of life for patients suffering from opioid-induced constipation.

How similar studies have performed: While there have been studies on probiotics for gastrointestinal issues, the specific use of BGP345A for opioid-induced constipation is a novel approach.

Eligibility criteria

Inclusion Criteria:

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 ,

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.

Exclusion Criteria:

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.

Where this trial is running

Amiens and 2 other locations

• CHU d'Amiens — Amiens, France (Recruiting)
• CHU DE NANTES (Hôpital Nord Laennec) — Saint- Herblain, France (Recruiting)
• CH de Valenciennes — Valenciennes, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Sonia Brinet

Conditions Opioid-Induced Constipation