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Clinical study on the efficacy and safety of Bifidobacterium Tetravaccine tablets (Siliankang) in the treatment of constipation during pregnancy: a single center, open, single arm clinical trial

Clinical study on the efficacy and safety of Bifidobacterium Tetravaccine tablets (Siliankang) in the treatment of constipation during pregnancy: a single center,

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047671
Enrollment
Unknown
Registered
2021-06-21
Start date
2021-06-30
Completion date
Unknown
Last updated
2022-02-28

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

Conditions

Constipation during pregnancy

Interventions

Sponsors

West China Second Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 20 to 40 years and the gestational age ranged from 16 to 32 weeks (including the cut-off value); 2. According to Rome IV diagnostic criteria for constipation, patients with functional constipation were diagnosed; 3. The duration of constipation after pregnancy was more than 1 month; 4. The patients participated voluntarily and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. There are intestinal organic diseases, such as inflammatory bowel disease, megacolon, intestinal obstruction, anorectal lesions, etc; 2. Those with occult blood in stool or anemia in pregnancy may affect the evaluation of the test; 3. Patients with severe cardiovascular, respiratory, kidney, blood, endocrine, nervous and mental diseases were considered to affect the evaluator; 4. History of allergy to Bifidobacterium Tetravaccine tablets or similar probiotics; 5. Those who have taken probiotics and other probiotics or laxatives within 2 weeks before taking the study drug; 6. Dysphagia, unable to take medicine on time; 7. Other patients considered unsuitable by the researchers.

Design outcomes

Primary

MeasureTime frame
Frequency of spontaneous defecation;

Secondary

MeasureTime frame
Time of first spontaneous defecation;Evaluation of overall therapeutic effect;Score of symptom Checklist-90 in patients with constipation;Frequency of using emergency medicine Kaiselu;

Countries

China

Contacts

Public ContactZhou Le

West China Second Hospital of Sichuan University

15184476542@163.com+86 15184476542

Outcome results

None listed

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