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The effect of probiotics and lactulose use for the prevention and treatment of opioid induced constipation during opioid use: a small observational pilot study

The effect of probiotics and lactulose use for the prevention and treatment of opioid induced constipation during opioid use: a small observational pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019226
Enrollment
Unknown
Registered
2018-10-31
Start date
2018-11-15
Completion date
Unknown
Last updated
2018-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer pain

Interventions

Group 1:Lactulose + Bifidobacterium triple live capsule
Group 2:Polyethylene glycol electrolyte powder

Sponsors

Shanghai 9th People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Aged 18-80 years old; (2) diagnosed as a malignant tumor by histopathological or cytological examination; (3) The patient has pain with NRS score = 4 points and needs to be treated with opioids; (4) Survival time of patients is expected to be more than 3 months; (5) Subjects voluntarily joined the study and signed informed consent. His or her compliance is good and intend to follow up.

Exclusion criteria

Exclusion criteria: (1) Probiotics or prebiotics are used within 4 weeks; (2) Patients use antibiotics with infectious diseases; (3) The patient is participating in other clinical trials, or the combined medication is forbidden, or the drug cannot be stopped during the study; (4) The investigator believes that the patient's history may affect the patient's ability to comply with the test or interfere with the assessment of the safety of the test drug; (5) Other circumstances considered unsuitable by the investigator; (6) With serious heart, kidney, liver and other important organ diseases; (7) With history of functional constipation (8) With intestinal obstruction or related gastrointestinal diseases that cause defecation difficulty; (9) Received opioid therapy in the past.

Design outcomes

Primary

MeasureTime frame
defecation frequency;

Secondary

MeasureTime frame
Quality of Life;

Countries

China

Contacts

Public ContactJiang Bin

Shanghai 9th People's Hospital, Shanghai Jiao Tong University School of Medicine

jiangbinwcr@163.com+86 13817606255

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026