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Effect of Lactobacillus DSM17938+ on Functional Constipation and Intestinal Flora in Pregnant Women

RecruitingNAAges 18 Years - 40 YearsFemalePeking Union Medical College Hospital
NCT06802042 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Constipation (constipation) is a common clinical symptom, including difficulty in defecation and / or reduced frequency of defecation, dry and hard stool, difficulty in defecation, feeling of inexhaustible defecation, feeling of anorectal obstruction, time-consuming defecation and need for auxiliary defecation. Reduced defecation means defecation less than 3 times a week.Constipation is very common during pregnancy, and studies have found that the incidence of constipation in pregnant women is as high as 40%. Among them, the prevalence of functional constipation in the early, middle, late and postpartum pregnancies is 35%, 39%, 21% and 17% respectively, with the highest in the early and middle pregnancies.Constipation can increase the psychological burden of pregnant women and affect their quality of life. Long-term severe constipation can also induce or aggravate hemorrhoids. Severe con

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📋 Eligibility rules (as published)
Inclusion Criteria: * (1) Pregnant women, age ≥18 years and \<40 years old, and gestational age \<28 weeks; (2) Must meet two or more of the following symptoms (Refer to the Roman IV standard): * It is difficult to defecate at least 25% of the time; * It is lumpy or hard stool at least 25% of the time; * It is not enough to defecate at least 25% of the time; * It is at least 25% of the time that there is anorectal obstruction or obstruction in defecation; * It requires manual assistance at least 25% of the time; ⑥It is spontaneous defecation less than 3 times a week. At the same time, loose stools rarely occur when no laxatives are used, which does not meet the diagnostic criteria of irritable bowel syndrome (IBS). The symptoms in the past 2 weeks have met the above diagnostic criteria. (3) Pregnant women receive and follow high-protein and high-fiber dietary guidance during the first trimester. (4) There were no other complications. (5) No medication was used to interfere with constipation symptoms. Exclusion Criteria: * (1) Non-pregnant women, age \<18 years or ≥40 years old, and gestational age ≥28 weeks; (2) Constipation caused by intestinal and systemic organic factors, drugs and other reasons, or concurrent with other non-constipation intestinal diseases; (3) History of use of antibiotics, probiotics, prebiotics, etc. in the past 2 weeks; (4) Pregnant women with thyroid disease, diabetes, hypertension, obesity, overweight or any metabolic disease.
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What it tests

  • Intervention with probiotic bacteria
  • Lactulose oral solution treatment
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Where

2 sites
Chinese Academy of Medical Science & Peking Union Medical College Hospital
Beijing, China
Wenzhou People's Hospital
Wenzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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