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

NCT ID: NCT06802042

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2026-12-31

Brief Summary

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

Functional Constipation (FC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention group

The intervention group (n=20) received free intervention with probiotic bacteria (Lactobacillus reuteri DSM17938+) for 4 weeks (1 bag bid)

Group Type: EXPERIMENTAL

Intervention with probiotic bacteria

Intervention Type: OTHER

The intervention group (n=20) received free intervention with probiotic bacteria (Lactobacillus reuteri DSM 8 +) for 4 weeks (1 bag bid)

control group

The control group (n=20) received lactulose oral solution free of charge for 4 weeks (1-2 bags qd for the first three days, and then increased or reduced according to constipation)

Group Type: ACTIVE_COMPARATOR

Lactulose oral solution treatment

Intervention Type: DRUG

The control group (n=20) received lactulose oral solution free of charge for 4 weeks (1-2 bags qd for the first three days, and then increased or reduced according to constipation)

Interventions

Intervention with probiotic bacteria

The intervention group (n=20) received free intervention with probiotic bacteria (Lactobacillus reuteri DSM 8 +) for 4 weeks (1 bag bid)

Intervention Type: OTHER

Lactulose oral solution treatment

The control group (n=20) received lactulose oral solution free of charge for 4 weeks (1-2 bags qd for the first three days, and then increased or reduced according to constipation)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Wenzhou People's Hospital

Wenzhou, Zhejiang, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Yin Sun

Role: CONTACT

sunyin@pumch.cn

+8618612672346

Facility Contacts

Sun Yin, MD

Role: primary

sunyin@pumch.cn

13901014196

Jianqiong Zheng

Role: primary

+8613968957721

Other Identifiers

K6993

Identifier Type: -

Identifier Source: org_study_id