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Study on the efficacy and safety of Bacillus coagulans in the treatment of constipation during pregnancy

Study on the efficacy and safety of Bacillus coagulans in the treatment of constipation during pregnancy

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098595
Enrollment
Unknown
Registered
2025-03-11
Start date
2023-07-12
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Gestational constipation

Interventions

Group B:Treatment with osmotic laxatives and probiotics
Group C:Treatment with osmotic laxatives and placebo

Sponsors

Nanchang Reproductive Hospital (Reproductive Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. At the beginning of the experiment, the subjects were between 18 and 40 years old. 2. Pregnant women diagnosed with constipation during pregnancy. 3. Meet the ROME IV diagnostic criteria for constipation. 4. Agree to take the product during the study. 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Antibiotics were taken during the test. 2. The subjects have taken probiotic preparations (tablets, powders, capsules, etc.) for 14 days before the test. 3. The subjects had taken some medication-assisted defecation within 30 days before the test. 4. Patients with intestinal obstructive diseases. 5. The researchers are not sure whether the subjects are willing or able to complete the experiment plan. 6. Subjects participate in other research projects during the study.

Design outcomes

Primary

MeasureTime frame
Fecal microbiota;Quality of life self-rating scale for constipation patients;

Secondary

MeasureTime frame
General clinical features;Blood routine examination;biochemical detection;

Countries

China

Contacts

Public ContactWeijun Chen

Nanchang Reproductive Hospital (Reproductive Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine)

112307068@qq.com+86 138 0706 2856

Outcome results

None listed

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