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A prospective, multicenter, randomized, double-blind, parallel controlled clinical study of BP-1 versus placebo in the prevention of gastrointestinal side effects caused by morphine

A prospective, multicenter, randomized, double-blind, parallel controlled clinical study of BP-1 versus placebo in the prevention of gastrointestinal side effects caused by morphine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057262
Enrollment
Unknown
Registered
2022-03-05
Start date
2022-03-21
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

tumor

Interventions

Experimental group:huaweiyi probiotics

Sponsors

The Second People's Hospital of Neijiang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years, male or female; 2. Patients with solid tumors confirmed by histopathology and/or cytology with stage III-IV imaging; 3. ECOG PS: 0-3 points; 4. Expected survival >= 1 month; 5. No opioid analgesic treatment was performed in the past, and the NRS score was moderate to severe cancer pain. The physician planned to use morphine hydrochloride (sulfuric acid) sustained release tablets for treatment; patients who had previously received opioid analgesic therapy should be eluted for 1 month and then treated with morphine hydrochloride (sulfate) sustained release tablets again. 6. The patients participated in the study voluntarily and signed the informed consent (ICF).

Exclusion criteria

Exclusion criteria: 1. Colon cancer, rectal cancer; 2. Multiple factors affecting the absorption of oral drugs (such as inability to swallow, nausea and vomiting, and intestinal obstruction); 3. Patients with chronic constipation; 4. Patients who have received surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, Chinese patent medicine or Chinese herbal therapy within 28 days and may cause digestive tract reactions; 5. Other patients deemed unsuitable for inclusion by the treating physician.

Design outcomes

Primary

MeasureTime frame
constipation;

Secondary

MeasureTime frame
nausea;vomit;abdominal distention;appetite;

Countries

China

Contacts

Public ContactGuomiao Li

The Second People's Hospital of Neijiang

115398656@qq.com+86 15681413850

Outcome results

None listed

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