Probiotic treatment for constipation in pregnant women

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

This study tests if a probiotic and a special liquid can help pregnant women with constipation feel better and improve their gut health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06802042 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Lactobacillus DSM17938 and lactulose oral solution on functional constipation in pregnant women. It aims to alleviate symptoms such as difficulty in defecation and improve intestinal flora. Eligible participants include pregnant women aged 18 to 40 with specific constipation symptoms, who will receive dietary guidance alongside the interventions. The study is designed to assess the efficacy of these treatments in enhancing the quality of life for pregnant women suffering from constipation.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 18 to 40 with functional constipation symptoms occurring at least 25% of the time.

Not a fit: Patients who do not meet the criteria for functional constipation or have irritable bowel syndrome may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve bowel function and overall well-being for pregnant women experiencing constipation.

How similar studies have performed: Previous studies have shown positive outcomes with probiotic treatments for constipation, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Chinese Academy of Medical Science & Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Wenzhou People's Hospital — Wenzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Yin Sun

Conditions Functional Constipation