Chronic Functional ConstipationPhase 1/2FMTFCFCNCT03018613
Fecal Microbiota Transplantation for Chronic Functional Constipation
A Phase 1/2 study testing Fecal Microbiota Transplantation and Normal Saline in people with Chronic Functional Constipation and Intestinal Bacteria Flora Disturbance, run by First Affiliated Hospital of Chengdu Medical College at 1 site in China.
Trial summary
Chronic functional constipation is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of chronic functional constipation is closely related to imbalance of intestinal flora .Moreover,types and quantity of intestinal flora may be related to… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation
- What is being tested?
- Fecal Microbiota Transplantation and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jul 2019
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects voluntarily participate in the trial and sign informed consent;
- sex is not limited,ranging from 18 to 75 years old;
- meet the diagnostic criteria for chronic functional constipation in patients;
- patients has been ruled out organic diseases of the large intestine within 1 year by colonoscopy or barium enema examination, and stool routine and occult blood examination are normal within 1 month;
- be able to communicate well with the researchers and follow the verification requirements.
Who cannot join
- does not meet the diagnostic criteria;
- with severe primary heart, liver, lung, kidney, blood or affect the survival of serious diseases;
- severe anemia and severe systemic infection;
- suspected or indeed have alcohol, drug abuse history;
- pregnancy or are preparing for pregnancy, and breastfeeding women;
- Those who are unwilling to accept the research measures or other reasons can not cooperate;
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- due to mental disorders can not give adequate informed consent;
- Participated in other clinical trials within 3 months before the start of the study;
- researchers believe that participates are not suitable for other reasons in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
IEC of Chengdu Medical College
Chendu, 610500
Xiaoan Li, Ph.D, +8613680868858, zqzy1983@163.com
About this study
Official title: Evaluation of the Effect of Fecal Microbiota Transplantation on Chronic Functional Constipation and Its Mechanism
Chronic functional constipation is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of chronic functional constipation is closely related to imbalance of intestinal flora .Moreover,types and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease，but the clinical efficacy of chronic functional constipation by fecal microbiota transplantation needs to be further explored.
Read the detailed description
Patients who meet the inclusion crit chronic functional constipation will be separated into two parts depending on acceptation or refuse of Fecal microbiota transplantation.Blood specimen from patients will be collected to analysis intestinal motility.
- Conditions
- Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation
- Being tested
- Fecal Microbiota Transplantation, Normal Saline
- Keywords
- Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationOther
Also called Fecal Microbiota Transplantation(FMT)
Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.
Normal SalineOther
Also called Normal Saline(NS)
Normal saline and the traditional treatments for chronic functional constipation in part 2
| Study group | Role | What they receive |
|---|---|---|
| treatment for part 1 | Active comparator | Fecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1. Receives: Other: Fecal Microbiota Transplantation |
| Placebo for part 2 | Placebo comparator | The traditional treatments and normal saline will be used in patients with chronic functional constipation in part 2 according to associated guidelines. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events complication rate in all patients in both groups
Measured: 3 months
Secondary outcomes (7)
Mean number of bowel movements per week
Measured: 4 weeks
Bristol stool scale
Measured: 4 weeks
Constipation-related symptoms assessments
Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4.
Measured: 4 weeks
Usage of laxatives or enemas as rescue medication
Measured: 4 weeks
Histological changes in the intestinal biopsy in both groups.
Measured: 4 weeks
Microbiota composition
Measured: 4 weeks
Nitric oxide(NO)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Functional ConstipationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoan Li, Ph.D, Study chair, First Affiliated Hospital of Chengdu Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018613
- Sponsor's protocol ID
- FMT-CFC
- Acronym
- FMTFCFC
- Status last verified
- Dec 2016
- First submitted
- 3 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Fecal Microbiota Transplantation on Chronic Functional Constipation and Its Mechanism
- ClinicalTrials.gov ID
- NCT03018613
- Acronym / sponsor ID
- FMTFCFC / FMT-CFC
- Conditions
- Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation
- Keywords
- Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical CollegeUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- 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 functional constipation is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of chronic functional constipation is closely related to imbalance of intestinal flora .Moreover,types and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease，but the clinical efficacy of chronic functional constipation by fecal microbiota transplantation needs to be further explored.
Detailed description
Patients who meet the inclusion crit chronic functional constipation will be separated into two parts depending on acceptation or refuse of Fecal microbiota transplantation.Blood specimen from patients will be collected to analysis intestinal motility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment for part 1 | Active comparator | Other: Fecal Microbiota TransplantationFecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1. |
| Placebo for part 2 | Placebo comparator | Other: Normal SalineThe traditional treatments and normal saline will be used in patients with chronic functional constipation in part 2 according to associated guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- subjects voluntarily participate in the trial and sign informed consent;
- sex is not limited,ranging from 18 to 75 years old;
- meet the diagnostic criteria for chronic functional constipation in patients;
- patients has been ruled out organic diseases of the large intestine within 1 year by colonoscopy or barium enema examination, and stool routine and occult blood examination are normal within 1 month;
- be able to communicate well with the researchers and follow the verification requirements.
Key exclusion criteria (9 listed)
- does not meet the diagnostic criteria;
- with severe primary heart, liver, lung, kidney, blood or affect the survival of serious diseases;
- severe anemia and severe systemic infection;
- suspected or indeed have alcohol, drug abuse history;
- pregnancy or are preparing for pregnancy, and breastfeeding women;
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 |
|---|---|---|
| Fecal Microbiota TransplantationAlso: Fecal Microbiota Transplantation(FMT)Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1. | Other | treatment for part 1 |
| Normal SalineAlso: Normal Saline(NS)Normal saline and the traditional treatments for chronic functional constipation in part 2 | Other | Placebo for part 2 |
Primary outcome
Number of adverse events complication rate in all patients in both groups
Time frame: 3 months
7 secondary outcomes
Mean number of bowel movements per week
Time frame: 4 weeks
Bristol stool scale
Time frame: 4 weeks
Constipation-related symptoms assessments
Time frame: 4 weeks
Usage of laxatives or enemas as rescue medication
Time frame: 4 weeks
Histological changes in the intestinal biopsy in both groups.
Time frame: 4 weeks
Microbiota composition
Time frame: 4 weeks
Nitric oxide(NO)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- 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. This study is not recruiting at the moment.
Xiaoan Li, Ph.D study chair
First Affiliated Hospital of Chengdu Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fecal Microbiota Transplantation and Normal Saline in people with Chronic Functional Constipation and Intestinal Bacteria Flora Disturbance, run by First Affiliated Hospital of Chengdu Medical College 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 5 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: status not confirmed, as of the sponsor's last update on 12 Jan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaoan Li, Ph.D (+8613880868858, zqzy1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events complication rate in all patients in both groups (time frame: 3 months). 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 12 Jan 2017.