Functional Constipation (FC)NCT06802042
Effect of Lactobacillus DSM17938+ on Functional Constipation and Intestinal Flora in Pregnant Women
A study testing Intervention with probiotic bacteria and Lactulose oral solution treatment in people with Functional Constipation (FC), run by Peking Union Medical College Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Functional Constipation (FC)
- What is being tested?
- Intervention with probiotic bacteria and Lactulose oral solution treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 9 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- (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;
Show all 9Show fewer
- 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.
- Pregnant women receive and follow high-protein and high-fiber dietary guidance during the first trimester.
- There were no other complications. (5) No medication was used to interfere with constipation symptoms.
Who cannot join
- (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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Chinese Academy of Medical Science & Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Sun Yin, MD, 13901014196, sunyin@pumch.cn
- Not yet recruiting
Wenzhou People's Hospital
Wenzhou, Zhejiang, 325200
Jianqiong Zheng, +8613968957721
About this study
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)
- Being tested
- Intervention with probiotic bacteria, Lactulose oral solution treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with probiotic bacteriaOther
The intervention group (n=20) received free intervention with probiotic bacteria (Lactobacillus reuteri DSM 8 +) for 4 weeks (1 bag bid)
Lactulose oral solution treatmentDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention group (n=20) received free intervention with probiotic bacteria (Lactobacillus reuteri DSM17938+) for 4 weeks (1 bag bid) Receives: Other: Intervention with probiotic bacteria |
| control group | Active comparator | 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) Receives: Drug: Lactulose oral solution treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of probiotic bacteria (Lactobacillus reuteri DSM17938+) on functional constipation in pregnant women during the first and second trimester
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start9 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation (FC)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802042
- Sponsor's protocol ID
- K6993
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactobacillus DSM17938+ on Functional Constipation and Intestinal Flora in Pregnant Women
- ClinicalTrials.gov ID
- NCT06802042
- Acronym / sponsor ID
- K6993
- Conditions
- Functional Constipation (FC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Intervention with probiotic bacteriaThe intervention group (n=20) received free intervention with probiotic bacteria (Lactobacillus reuteri DSM17938+) for 4 weeks (1 bag bid) |
| control group | Active comparator | Drug: Lactulose oral solution treatmentThe 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) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- (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):
- 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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention with probiotic bacteriaThe intervention group (n=20) received free intervention with probiotic bacteria (Lactobacillus reuteri DSM 8 +) for 4 weeks (1 bag bid) | Other | intervention group |
| Lactulose oral solution treatmentThe 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) | Drug | control group |
Primary outcome
Efficacy of probiotic bacteria (Lactobacillus reuteri DSM17938+) on functional constipation in pregnant women during the first and second trimester
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with probiotic bacteria and Lactulose oral solution treatment in people with Functional Constipation (FC), run by Peking Union Medical College Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yin Sun (+8618612672346, sunyin@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of probiotic bacteria (Lactobacillus reuteri DSM17938+) on functional constipation in pregnant women during the first and second trimester (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.