Probiotic treatment for constipation in pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: sunyin@pumch.cn
• Phone: +8618612672346

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.