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Effect of probiotics complex for preventing antibiotic-associated diarrhea: a multicenter, randomized, controlled trial

Effect of probiotics complex for preventing antibiotic-associated diarrhea: a multicenter, randomized, controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026637
Enrollment
Unknown
Registered
2019-10-16
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-10-21

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

Conditions

antibiotic-associated diarrhea

Interventions

placebo group:placebo

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~70 years old; 2. Antibiotic treatment =3 days; 3. Good gastrointestinal function; 4. Signing informed consent.

Exclusion criteria

Exclusion criteria: 1. Diarrhea occurred within 2 weeks before the trial; 2. Combined with digestive diseases that cause diarrhea, such as acute enteritis, radiation enteritis, ischemic colitis, ulcerative colitis, digestive tract tumors or allergic gastrointestinal syndrome; 3. Receiving immunosuppressive therapy or any disease that causes immunosuppression (including hematological malignancy, AIDS); 4. Long-term use of antibiotics before the trial; 5. Having received digestive surgery within 1 year prior to the trial or digestive surgery is planned; 6. Clostridium difficile infection was diagnosed 3 months before the trial; 7. Taking probiotics during the trial or within 15 days before the trial; 8. Tube feeding, gastrointestinal fistula or total parenteral nutrition; 9. Pregnant or lactating women; 10. Fecal incontinence; 11. Lactose intolerance; 12. Participating in other clinical trials; 13. Other circumstances not suitable for this study.

Design outcomes

Primary

MeasureTime frame
Incidence of AAD;

Secondary

MeasureTime frame
Defecation frequency;Fecal trait;Diarrhea duration;Stool routine examination;Intestinal flora analysis;Safety indicators such as liver and kidney function;

Countries

China

Contacts

Public ContactZhiyong Rao

West China Hospital, Sichuan University

raoyong100@126.com+86 18980602276

Outcome results

None listed

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