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Effect of probiotics on perinatal health outcomes: a randomized controlled clinical trial

Effect of probiotics on perinatal health outcomes: a randomized controlled clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069418
Enrollment
Unknown
Registered
2023-03-15
Start date
2023-03-13
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Probiotics for postpartum health

Interventions

Probiotic intervention group:Each person was given a dry vacuum packed probiotic bag
control group:None

Sponsors

Tsinghua University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. The mother has no metabolic diseases such as diabetes; 2. The mother has no infectious diseases such as hepatitis B and HIV; 3. The mother has no breast and breast diseases such as sunken nipple; 4. Postpartum weight is 5 kg or more higher than the pre-pregnancy weight.

Exclusion criteria

Exclusion criteria: 1. The mother has a severe mental condition that prevents her from cooperating well with researchers; 2. Oral probiotics or prebiotics within the last 4 weeks; 3. Have taken antibiotics or received any antibiotics or purgatory drugs in the last 4 weeks; 4. Severe diarrhea (watery stool more than 3 times a day for 3 consecutive days or more) in the last 4 weeks; 5. Severe constipation in the last 4 weeks (two or less bowel movements per week with difficulty defecating); 6. History of intestinal disease, other severe digestive diseases, such as colorectal polyps, colorectal cancer have been diagnosed; 7. People with depression at baseline screening.

Design outcomes

Primary

MeasureTime frame
Diagnosis of postpartum depressive state;Body weight retention;Detection of body fat composition;

Secondary

MeasureTime frame
Blood gamma-aminobutyric acid, serotonin content detection;Detection of intestinal flora and specific colonization of intervention bacteria;Fecal SCFAs detection;

Countries

China

Contacts

Public ContactAi Zhao

Tsinghua University

aizhao18@tsinghua.edu.cn+86 138 1113 1994

Outcome results

None listed

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