Gut MicrobiotaNCT03308461
Fecal Microbiota Transplantation for Constipation
A study testing Fecal Microbiota suspension in people with Gut Microbiota and Constipation, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota… Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Gut Microbiota, Constipation
- What is being tested?
- Fecal Microbiota suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2013to 1 May 2017
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age between 14-80 years old;
- difficult defecation with more than six months (a. straining during defecation; b. sensation of incomplete evacuation; c. sensation of anorectal blockage; d. manual maneuvers to facilitate defecation).
Who cannot join
- difficult defecation due to secondary factors (e.g. drugs, pelvic surgery, psychiatric disorders);
- with history of gastrointestinal diseases such as cancer, inflammatory bowel diseases (IBD);
- pregnant or breast-feeding women;
- infection with pathogenic bacteria. Enrolled patients were divided into hard-stool group and loose-stool group according to their stool patterns. All patients were followed up for 12 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
About this study
Official title: Fecal Microbiota Transplantation for Constipation With Difficult Defecation
Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation.
Read the detailed description
Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation. Patients underwent single FMT in this study were divided into hard-stool group and loose-stool group. All patients were assessed before FMT and during 12-week follow-up after FMT.
- Conditions
- Gut Microbiota, Constipation
- Being tested
- Fecal Microbiota suspension
- Keywords
- difficult defecation, fecal microbiota transplantation, stool pattern
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota suspensionDrug
The prepared microbiota suspension was infused into mid-gut.
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation (FMT) | Experimental | Patients underwent single FMT in this studyAll patients were assessed before FMT and during 12-week follow-up after FMT. Receives: Drug: Fecal Microbiota suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
defecation frequency
frequency of defecation per week
Measured: 12 weeks
stool consistency
The category of stool consistency score based on the BSS (Bristol Stool Form Scale)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start1 May 2013
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiotaStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308461
- Sponsor's protocol ID
- FMT-CN-160107
- Status last verified
- May 2016
- First submitted
- 7 Oct 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vandeputte D, Falony G, Vieira-Silva S, Tito RY, Joossens M, Raes J. Stool consistency is strongly associated with gut microbiota richness and composition, enterotypes and bacterial growth rates. Gut. 2016 Jan;65(1):57-62. doi: 10.1136/gutjnl-2015-309618. Epub 2015 Jun 11.
PubMed 26069274Tigchelaar EF, Bonder MJ, Jankipersadsing SA, Fu J, Wijmenga C, Zhernakova A. Gut microbiota composition associated with stool consistency. Gut. 2016 Mar;65(3):540-2. doi: 10.1136/gutjnl-2015-310328. Epub 2015 Aug 14. No abstract available.
PubMed 26276682Duncan SH, Louis P, Flint HJ. Lactate-utilizing bacteria, isolated from human feces, that produce butyrate as a major fermentation product. Appl Environ Microbiol. 2004 Oct;70(10):5810-7. doi: 10.1128/AEM.70.10.5810-5817.2004.
PubMed 15466518
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for Constipation With Difficult Defecation
- ClinicalTrials.gov ID
- NCT03308461
- Acronym / sponsor ID
- FMT-CN-160107
- Conditions
- Gut Microbiota, Constipation
- Keywords
- difficult defecation, fecal microbiota transplantation, stool pattern
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 12 Oct 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.
Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation.
Detailed description
Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation. Patients underwent single FMT in this study were divided into hard-stool group and loose-stool group. All patients were assessed before FMT and during 12-week follow-up after FMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation (FMT) | Experimental | Drug: Fecal Microbiota suspensionPatients underwent single FMT in this studyAll patients were assessed before FMT and during 12-week follow-up after FMT. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- age between 14-80 years old;
- difficult defecation with more than six months (a. straining during defecation; b. sensation of incomplete evacuation; c. sensation of anorectal blockage; d. manual maneuvers to facilitate defecation).
Key exclusion criteria (4 listed)
- difficult defecation due to secondary factors (e.g. drugs, pelvic surgery, psychiatric disorders);
- with history of gastrointestinal diseases such as cancer, inflammatory bowel diseases (IBD);
- pregnant or breast-feeding women;
- infection with pathogenic bacteria. Enrolled patients were divided into hard-stool group and loose-stool group according to their stool patterns. All patients were followed up for 12 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 |
|---|---|---|
| Fecal Microbiota suspensionThe prepared microbiota suspension was infused into mid-gut. | Drug | Fecal microbiota transplantation (FMT) |
Primary outcome
defecation frequency
Time frame: 12 weeks
frequency of defecation per week
stool consistency
Time frame: 12 weeks
The category of stool consistency score based on the BSS (Bristol Stool Form Scale)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Background: PubMed 26069274Vandeputte D, Falony G, Vieira-Silva S, Tito RY, Joossens M, Raes J. Stool consistency is strongly associated with gut microbiota richness and composition, enterotypes and bacterial growth rates. Gut. 2016 Jan;65(1):57-62. doi: 10.1136/gutjnl-2015-309618. Epub 2015 Jun 11.
- Background: PubMed 26276682Tigchelaar EF, Bonder MJ, Jankipersadsing SA, Fu J, Wijmenga C, Zhernakova A. Gut microbiota composition associated with stool consistency. Gut. 2016 Mar;65(3):540-2. doi: 10.1136/gutjnl-2015-310328. Epub 2015 Aug 14. No abstract available.
- Background: PubMed 15466518Duncan SH, Louis P, Flint HJ. Lactate-utilizing bacteria, isolated from human feces, that produce butyrate as a major fermentation product. Appl Environ Microbiol. 2004 Oct;70(10):5810-7. doi: 10.1128/AEM.70.10.5810-5817.2004.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota suspension in people with Gut Microbiota and Constipation, run by The Second Hospital of Nanjing Medical University 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 12 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
defecation frequency (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308461, which also lists 3 linked publications.
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 Oct 2017.