Actively Recruiting
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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Constipation is a common symptom affecting many pregnant women, characterized by difficulty or reduced frequency of bowel movements, hard stools, and feelings of incomplete evacuation. This condition can negatively impact quality of life and pregnancy outcomes. Researchers are studying functional constipation in pregnant women, focusing on the role of intestinal flora imbalance and evaluating a probiotic strain, Lactobacillus reuteri DSM17938+, which has shown promise in relieving constipation symptoms in other populations but lacks data in pregnant women in China. Participants in this study are randomly assigned to one of two groups. One group receives Lactobacillus reuteri DSM17938+ probiotic twice daily for four weeks, while the other group receives lactulose oral solution daily for four weeks, with dosage adjusted based on constipation severity. The study specifically targets pregnant women under 28 weeks gestation during their first and second trimesters. Both treatments are provided free of charge. During the trial, participants are monitored for the effectiveness of the probiotic on constipation symptoms over four weeks. Researchers will assess changes in bowel habits, abdominal discomfort, and intestinal flora. The study tracks adherence through scheduled visits, while also monitoring safety and any adverse effects. The total participation time corresponds to the treatment duration of four weeks, focusing on early pregnancy stages to understand the probiotic’s impact on functional constipation.
CONDITIONS
Brief Title
Effect of Lactobacillus DSM17938+ on Functional Constipation and Intestinal Flora in Pregnant Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 18 to under 40 years and gestational age less than 28 weeks
- Must have two or more symptoms meeting Rome IV criteria for functional constipation, including difficulty defecating, hard stools, incomplete evacuation, anorectal obstruction, manual assistance, or less than 3 spontaneous bowel movements per week
- Symptoms must have occurred in the past 2 weeks
- Receive and follow high-protein and high-fiber dietary guidance during the first trimester
- No other complications
- No medication used that interferes with constipation symptoms
You will not qualify if you...
- Non-pregnant women or age under 18 or 40 years and older, or gestational age 28 weeks or more
- Constipation caused by organic intestinal or systemic factors, drugs, or other non-constipation intestinal diseases
- Use of antibiotics, probiotics, or prebiotics within the past 2 weeks
- History of thyroid disease, diabetes, hypertension, obesity, overweight, or any metabolic disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants receive treatment with either probiotic bacteria (Lactobacillus reuteri DSM17938+) or lactulose oral solution for functional constipation during pregnancy.
1 baseline visit and 1 follow-up visit
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
Research Team
Y
Yin Sun
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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