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Safety and Preliminary Efficacy of BGP345A in Constipation Due to Opioid-based Medications

NCT05133076 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Opioid-Induced Constipation

Interventions

BIOLOGICAL

Lactobacillus gasseri BGP345A

Active and placebo capsules for oral use

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • BioFortis

    collaborator OTHER

  • BioGaia Pharma AB

    lead INDUSTRY

Principal Investigators

  • Petra J Lierud · BioGaia Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2024-12-12
Completion
2024-12-12

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05133076 on ClinicalTrials.gov