constipation in pregnancy
Conditions
Interventions
test team:Bifidobacterium quadruplex viable tablets (trade name: Silankang)
Sponsors
The West China Second Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: Selection criteria: 1. The subject participated voluntarily and signed the informed consent form; 2. Age: 20~40 years old when signing the informed consent (including the boundary value); 3. 12~22 weeks (including boundary value); 4. Fetal development conforms to the gestational age; 5. At the screening visit, the subject met the Rome symptomatic criteria for functional constipation (Appendix 1), complete Number of spontaneous defecation 3 times / week and number of spontaneous defecation?6 times / week; 6. For constipation during pregnancy, the duration is 1 month when signing informed consent; 7. At the end of the run-in period, the subject still met the Rome IV symptomatic criteria for functional constipation (Appendix 1), Complete spontaneous defecation 3 times / week and spontaneous defecation <6 times / week.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. The subject had a history of allergy to bifidobacterium tetrad live tablets or similar microecology or emergency drugs; 2. The subjects had a history of spontaneous abortion, habitual abortion, threatened abortion and other pregnancy complications; 3. Severe pregnancy hypertension: systolic blood pressure 160mmHg and (or) diastolic blood pressure 110mmHg; 4. The subject had a history of diabetes before pregnancy or fasting blood glucose FDG=5.1mmol/L during screening; 5. The subject's pregnancy is an abnormal pregnancy or the probability of premature birth or abortion is high as judged by the investigator; 6. The subjects had gastrointestinal organic diseases, such as active peptic ulcer, tumor, inflammatory bowel disease, and giant Colon, intestinal obstruction, anorectal lesions, etc.; 7. Subjects have fecal occult blood or pregnancy anemia, which may affect the test evaluation; 8. The subjects had severe cardiovascular, respiratory, renal, blood, endocrine, neurological and mental conditions Other systemic diseases that the investigator considers to affect the trial evaluation; 9. The subject had taken probiotics (including probiotics and probiotics within 2 weeks before taking the experimental drug Shengyuan, yuan health products) or laxatives; 10. The subject is receiving oral or intramuscular or intravenous antibiotics; 11. The subject had difficulty swallowing and could not take the medication on time; 12 The subject had severe vomiting and a modified version of the nausea and vomiting quantification Scale (NVP) score of 13 or Diagnosis of hyperemesis gravidum; 13. The subject used the emergency medication within 48 hours prior to the first dose of the investigational drug; 14. Participants used used medication, restricted, and / or treatment; 15. The subject has participated in other interventional clinical studies within 3 months prior to the screening; 16. Other circumstances that the investigator considers inappropriate for inclusion. Note: abnormal vital signs or laboratory examination results during screening can be received after evaluation by the investigator Subjects were retest for non-medical intervention and the results were used as screening assessment criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with an average of 3 complete spontaneous defecation (SCBM) per week and at least 1 increase from baseline at 4 weeks, 6 weeks, and 8 weeks after trial medication.; | — |
Countries
China
Contacts
Public ContactXinghui Liu
The West China Second Hospital of Sichuan University
Outcome results
None listed