Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
NCT06802042

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

Led by Peking Union Medical College Hospital · Updated on 2025-01-30

40

Participants Needed

2

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 constipation can induce uterine contractions, which will adversely affect the pregnancy outcome of pregnant women.Studies have found that there is a difference in the abundance of intestinal flora between patients with constipation during pregnancy and pregnant women without digestive tract diseases.Although microecological preparations are not front-line drugs for the treatment of chronic constipation, they can promote intestinal peristalsis and the recovery of gastrointestinal motility by regulating the imbalance of intestinal flora. More and more researchers recommend them as long-term adjuvant drugs for chronic constipation. Probiotics are a type of microecological preparation, which refers to living microorganisms that can have beneficial health effects on the host after ingesting a sufficient amount.It is relatively safe to supplement probiotics during pregnancy.Our research team found a probiotic strain, Lactobacillus reuteri DSM17938+, which has no significant difference in improving constipation symptoms in patients with constipation compared with lactulose, and is even more effective than lactulose in alleviating abdominal pain and flatulence symptoms.However, clinical studies proving that Lactobacillus reuteri DSM17938 + is effective on constipation are generally concentrated abroad, and mainly focus on infants and young children, children, adults\] or intestinal colic. Data on maternal population in China is lacking.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 18 years or older and younger than 40 years, with gestational age less than 28 weeks
  • Must have two or more constipation symptoms (difficulty defecating, lumpy or hard stools, incomplete evacuation, anorectal obstruction, manual assistance needed) at least 25% of the time
  • Spontaneous defecation less than 3 times a week, with rare loose stools and no irritable bowel syndrome diagnosis
  • Symptoms must have been present in the past 2 weeks
  • Pregnant women should follow high-protein and high-fiber diet guidance during the first trimester
  • No other pregnancy complications
  • No medication use that affects constipation symptoms
Not Eligible

You will not qualify if you...

  • Non-pregnant women, younger than 18 years or 40 years and older, or gestational age 28 weeks or more
  • Constipation caused by organic intestinal or systemic diseases, drugs, or other intestinal diseases not related to constipation
  • Use of antibiotics, probiotics, or prebiotics in the past 2 weeks
  • Pregnant women with thyroid disease, diabetes, hypertension, obesity, overweight, or any metabolic disease

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

2

Wenzhou People's Hospital

Wenzhou, Zhejiang, China, 325200

Not Yet Recruiting

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Research Team

Y

Yin Sun

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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