Constipation - FunctionalNCT03233100
FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
A study testing FMT in people with Constipation - Functional and Depressive Symptoms, run by Jianfeng Gong at 1 site in China.
Trial summary
Constipated patients often have mental problems such as depression and anxiety due to difficult defecation. Our previous studies have proved the efficacy of FMT treating constipation. Meanwhile it is believed that mental diseases are correlated to gut microbiota. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation - Functional, Depressive Symptoms, Anxiety Symptoms
- What is being tested?
- FMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who were diagnosed as functional constipation (FC) according to Rome Ⅳ criteria were enrolled.
- Age ≥ 18 years
- Body mass index of 18-25 kg/m2.
- HAMA ≥ 14 and/or HAMD (17 items) ≥ 17
Who cannot join
- History of sever mental disorders such as schizophrenia and bipolar disorder
- History of organic intestinal disorders
- History of gastrointestinal surgery
- Pregnant or breast-feeding women
- Infection with enteric pathogen
- Usage of probiotics, prebiotics, antibiotics within the last month
- Uncontrolled hepatic, renal, cardiovascular, and respiratory, or any diseases that in the opinion of the investigator, could affect intestinal transit and the intestinal microbiota.
- Patients who could not complete the follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210000
Jianfeng Gong, MD, +86-25-80860036, gongjianfeng@aliyun.com
About this study
Constipated patients often have mental problems such as depression and anxiety due to difficult defecation. Our previous studies have proved the efficacy of FMT treating constipation. Meanwhile it is believed that mental diseases are correlated to gut microbiota. This trial is based on the theory of the gut-brain-microbiota axis. Patients with constipation, depression and/or anxiety are performed FMT, laboratory, imaging and microbiota examinations, and clinical follow-up, to observe the clinical efficiency of FMT and the potential role of gut microbiome in these gut-brain disorders.
- Being tested
- FMT
- Keywords
- FMT, gut microbiota, gut-brain disorder, constipation, depression, anxiety
- Medical subject headings
- Depression, Anxiety Disorders, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMTOther
fecal microbiota transplantation
| Study group | Role | What they receive |
|---|---|---|
| FMT group | Experimental | Not described Receives: Other: FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSBMs per week
complete spontaneous bowl movements per week
Measured: 12 weeks after treatment
HAMA
score of Hamilton Anxiety Rating Scale
Measured: 12 weeks after treatment
HAMD
score of Hamilton Depression Rating Scale
Measured: 12 weeks after treatment
Secondary outcomes (4)
Wexner
score of Wexner
Measured: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
PAC-SYM
score of PAC-SYM
Measured: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Bristol Bristol PAC-SYM
score of Bristol score of Bristol
Measured: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
PAC-QOL
score of PAC-QOL
Measured: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start30 Jul 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianfeng Gong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianfeng Gong, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233100
- Sponsor's protocol ID
- STC-D-A-2017-FMT
- Status last verified
- Jul 2017
- First submitted
- 22 Jul 2017
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
- ClinicalTrials.gov ID
- NCT03233100
- Acronym / sponsor ID
- STC-D-A-2017-FMT
- Keywords
- FMT, gut microbiota, gut-brain disorder, constipation, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jianfeng GongUniversity, hospital or other
- Study start
- 30 Jul 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 28 Jul 2017 (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.
Constipated patients often have mental problems such as depression and anxiety due to difficult defecation. Our previous studies have proved the efficacy of FMT treating constipation. Meanwhile it is believed that mental diseases are correlated to gut microbiota. This trial is based on the theory of the gut-brain-microbiota axis. Patients with constipation, depression and/or anxiety are performed FMT, laboratory, imaging and microbiota examinations, and clinical follow-up, to observe the clinical efficiency of FMT and the potential role of gut microbiome in these gut-brain disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT group | Experimental | Other: FMT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who were diagnosed as functional constipation (FC) according to Rome Ⅳ criteria were enrolled.
- Age ≥ 18 years
- Body mass index of 18-25 kg/m2.
- HAMA ≥ 14 and/or HAMD (17 items) ≥ 17
Key exclusion criteria (8 listed)
- History of sever mental disorders such as schizophrenia and bipolar disorder
- History of organic intestinal disorders
- History of gastrointestinal surgery
- Pregnant or breast-feeding women
- Infection with enteric pathogen
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 |
|---|---|---|
| FMTfecal microbiota transplantation | Other | FMT group |
Primary outcome
CSBMs per week
Time frame: 12 weeks after treatment
complete spontaneous bowl movements per week
HAMA
Time frame: 12 weeks after treatment
score of Hamilton Anxiety Rating Scale
HAMD
Time frame: 12 weeks after treatment
score of Hamilton Depression Rating Scale
4 secondary outcomes
Wexner
Time frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
PAC-SYM
Time frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Bristol Bristol PAC-SYM
Time frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
PAC-QOL
Time frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
Related trials for Constipation - Functional
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
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. This study is not recruiting at the moment.
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 Depressive Symptoms, run by Jianfeng Gong 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianfeng Gong, MD (+86-25-80860036, gongjianfeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSBMs per week (time frame: 12 weeks after treatment). 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 28 Jul 2017.