Constipation - FunctionalNCT07387952
The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study
A study testing FMT in people with Constipation - Functional and Fecal Microbiota Transplantation (FMT), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Chronic constipation is a common gastrointestinal disease with a global prevalence of about 15%, significantly affecting daily life and quality of life. Traditional treatments primarily rely on laxatives, which may lead to adverse effects with prolonged use, while surgical interventions have limited patient… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Constipation - Functional, Fecal Microbiota Transplantation (FMT), Chronic Constipation
- What is being tested?
- FMT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 70.
- Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions:
- Symptom requirements: The following at least 2 items should occur in ≥25% of bowel movements: a. Straining during defecation; b. Hard stool (Bristol Stool Classification score 1-2); c. Feeling of incomplete evacuation; d. Rectal obstruction sensation; e. Need for finger assistance during defecation; f. Spontaneous bowel movements <3 times per week.
- It is rare to have loose stools without laxatives.
- Exclusion of irritable bowel syndrome (IBS): IBS diagnosis criteria not meeting Rome IV.
- Disease course requirements: Symptoms persist for at least 6 months and meet the above criteria within the last 3 months.
- Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective.
Who cannot join
- Pregnancy or lactation.
- Unable to take the intervention product or complete the examination as required.
- Language expression disorder or mental illness.
- Physical examination showed severe liver and kidney dysfunction.
- Acute gastrointestinal disease within 4 weeks.
- Constipation caused by surgery in the past 4 weeks.
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- History or abnormal examination: cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness, stroke, heart disease, cirrhosis, renal failure, hematopoietic system diseases, organic bowel disease suggested by colonoscopy or imaging.
- Participation in other clinical trials within 3 months prior to enrollment.
- Other health problems are not suitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Pengguang Yan, +8618810309887, pengchengf@mail.sdu.edu.cn
About this study
Chronic constipation is a common gastrointestinal disease with a global prevalence of about 15%, significantly affecting daily life and quality of life. Traditional treatments primarily rely on laxatives, which may lead to adverse effects with prolonged use, while surgical interventions have limited patient acceptance. Recent studies indicate that gut microbiota therapies-including probiotics, prebiotics, synbiotics, postbiotics, and fecal microbiota transplantation (FMT)-can effectively manage chronic constipation. This study aims to investigate the safety and efficacy of FMT combined with a prebiotic nutritional intervention (using a co-localization strategy) in the treatment of functional constipation. Additionally, the investigators will explore changes in fecal microbiota and metabolomic profiles following the treatment.
- Being tested
- FMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMTProcedure or surgery
Also called FMT with nutritional intervention
In this group, colonoscopy is performed and a colostomy is placed in the ileocecal region. Bacterial infusion is performed for 3 days with 100ml graft per day. Within 30 minutes after receiving the microbiota transplantation, take the high dietary fiber preparation and dissolve it in water according to the instructions. Blood, stool, and colonoscopy-derived mucosal samples are collected before and after FMT and Researchers conduct follow-ups.
| Study group | Role | What they receive |
|---|---|---|
| FMT with nutritional intervention group | Experimental | Fecal microbiota transplantation (FMT) is a method for treating imbalances in the intestinal microbiota, by extracting a portion of feces from a healthy individual that contains a diverse population of beneficial bacteria, processing it, and transplanting it into the digestive system of the recipient to restore a balanced intestinal microbiota. Nutritional intervention involves high dietary fiber preparation. Receives: Procedure: FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Defecation (Spontaneous Bowel Movements)
The number of Spontaneous Bowel Movements (SBM) per week recorded by the participant in a diary.
Measured: Baseline, Weeks 4, 8, 12, 18, and 24
Stool Consistency Assessed by Bristol Stool Form Scale (BSFS)
Stool consistency is evaluated using the Bristol Stool Form Scale. The scale ranges from Type 1 (Separate hard lumps) to Type 7 (Liquid consistency). Type 1 and 2 indicate constipation, while Type 3 and 4 are considered normal. Higher scores indicate looser stool consistency.
Measured: Baseline, Weeks 4, 8, 12, 18, and 24
Severity of Defecation Straining
Patient-reported assessment of the effort required to defecate. Participants rate their straining severity on a scale (e.g., from 0 to 3, where 0 represents no straining and 3 represents severe straining). Higher scores indicate worse symptoms.
Measured: Baseline, Weeks 4, 8, 12, 18, and 24
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events
Number of participants with adverse events. Assessment includes monitoring for specific gastrointestinal symptoms (e.g., aggravation of diarrhea, abdominal discomfort/bloating) and systemic infections (e.g., secondary intestinal infection, bacteremia). Safety is assessed via telephone and offline visits.
Measured: From baseline through Week 24
Change in Gut Microbiota Composition Assessed by Metagenomic Sequencing
Fecal samples are collected to analyze the changes in the gut microbiota structure. Analysis includes the relative abundance of bacterial species and diversity indices (e.g., Shannon index) using Metastats analysis to compare pre- and post-treatment compositions.
Measured: Baseline, Weeks 2, 4, 8, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start30 Jul 2025
- Primary completion31 Dec 2026 (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 Constipation - FunctionalStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingnan Li, MD, Ph.D, Study chair, Peking Union Medical College Hospital, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387952
- Sponsor's protocol ID
- I-25PJ1600
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 4 Feb 2026
- Results posted
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study
- ClinicalTrials.gov ID
- NCT07387952
- Acronym / sponsor ID
- I-25PJ1600
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Feb 2026 (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.
Chronic constipation is a common gastrointestinal disease with a global prevalence of about 15%, significantly affecting daily life and quality of life. Traditional treatments primarily rely on laxatives, which may lead to adverse effects with prolonged use, while surgical interventions have limited patient acceptance. Recent studies indicate that gut microbiota therapies-including probiotics, prebiotics, synbiotics, postbiotics, and fecal microbiota transplantation (FMT)-can effectively manage chronic constipation. This study aims to investigate the safety and efficacy of FMT combined with a prebiotic nutritional intervention (using a co-localization strategy) in the treatment of functional constipation. Additionally, the investigators will explore changes in fecal microbiota and metabolomic profiles following the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT with nutritional intervention group | Experimental | Procedure: FMTFecal microbiota transplantation (FMT) is a method for treating imbalances in the intestinal microbiota, by extracting a portion of feces from a healthy individual that contains a diverse population of beneficial bacteria, processing it, and transplanting it into the digestive system of the recipient to restore a balanced intestinal microbiota. Nutritional intervention involves high dietary fiber preparation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 to 70.
- Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions:
- Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective.
Key exclusion criteria (9 listed)
- Pregnancy or lactation.
- Unable to take the intervention product or complete the examination as required.
- Language expression disorder or mental illness.
- Physical examination showed severe liver and kidney dysfunction.
- Acute gastrointestinal disease within 4 weeks.
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 |
|---|---|---|
| FMTAlso: FMT with nutritional interventionIn this group, colonoscopy is performed and a colostomy is placed in the ileocecal region. Bacterial infusion is performed for 3 days with 100ml graft per day. Within 30 minutes after receiving the microbiota transplantation, take the high dietary fiber preparation and dissolve it in water according to the instructions. Blood, stool, and colonoscopy-derived mucosal samples are collected before and after FMT and Researchers conduct follow-ups. | Procedure or surgery | FMT with nutritional intervention group |
Primary outcome
Frequency of Defecation (Spontaneous Bowel Movements)
Time frame: Baseline, Weeks 4, 8, 12, 18, and 24
The number of Spontaneous Bowel Movements (SBM) per week recorded by the participant in a diary.
Stool Consistency Assessed by Bristol Stool Form Scale (BSFS)
Time frame: Baseline, Weeks 4, 8, 12, 18, and 24
Stool consistency is evaluated using the Bristol Stool Form Scale. The scale ranges from Type 1 (Separate hard lumps) to Type 7 (Liquid consistency). Type 1 and 2 indicate constipation, while Type 3 and 4 are considered normal. Higher scores indicate looser stool consistency.
Severity of Defecation Straining
Time frame: Baseline, Weeks 4, 8, 12, 18, and 24
Patient-reported assessment of the effort required to defecate. Participants rate their straining severity on a scale (e.g., from 0 to 3, where 0 represents no straining and 3 represents severe straining). Higher scores indicate worse symptoms.
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: From baseline through Week 24
Change in Gut Microbiota Composition Assessed by Metagenomic Sequencing
Time frame: Baseline, Weeks 2, 4, 8, 12, 18, and 24
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 4 Feb 2026.
- 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.
Jingnan Li, MD, Ph.D study chair
Peking Union Medical College Hospital, Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMT in people with Constipation - Functional and Fecal Microbiota Transplantation (FMT), run by Peking Union Medical College Hospital at 1 site 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 7 inclusion and 9 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Pengguang Yan (+8618810309887, pengchengf@mail.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Defecation (Spontaneous Bowel Movements) (time frame: Baseline, Weeks 4, 8, 12, 18, and 24). The study lists 3 primary outcomes in all. 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 4 Feb 2026.