Slow Transit ConstipationPhase 2NCT02676388
Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation
A Phase 2 study testing Freeze-dried, Capsulized FMT and Fresh FMT in people with Slow Transit Constipation, run by Jinling Hospital, China at 1 site in China.
Trial summary
The purpose of this study is to compare the effect of freeze-dried, capsulized FMT and fresh FMT in adults with slow transit constipation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Slow Transit Constipation
- What is being tested?
- Freeze-dried, Capsulized FMT and Fresh FMT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2016
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic constipation according to Rome III criteria, defined as two or fewer spontaneous, complete bowel movements (SCBMs) per week for a minimum of 6 months;
- Age ≥ 18 years;
- BMI: 18.5-25 kg/m2;
- Slow colonic transit confirmed by colonic transit test (colonic transit time (CTT) > 48 hours);
- Normal anorectal manometry, with no evidence of dyssynergia and confirmed ability to expel rectal balloon;
- No radiographic evidence of functional (i.e. pelvic floor dyssynergia) or anatomical (i.e. significant rectocele and intussusception) impediment to the expulsion of the radio-opaque contrast;
- Disease duration > 1 year;
- Traditional treatment with dietary modification, laxatives (including osmotic and stimulant laxatives), and biofeedback tried over the past 6 months without success;
Who cannot join
- Bowel constipation due to innate factor (i.e. megacolon) or secondary interventions (i.e. drugs, endocrine, metabolic, neurologic or psychologic disorders);
- History or evidence of gastrointestinal diseases (i.e. obstruction, cancer, inflammatory bowel diseases) ;
- Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
- Previous proctological or perianal surgery;
- A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;
- Pregnant or breast-feeding women;
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- Infection with enteric pathogen;
- Usage of probiotics, prebiotics and/or synbiotics within the last month;
- Usage of antibiotics and/or PPIs within the last 3 months;
- Smoking or alcohol addiction within the last 3 months;
- Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease;
- Disease or therapy with drugs (i.e. antidepressants, opioid narcotic analgesics, anticholinergics, calcium antagonists, nitrates, antimuscarinics) that, in the opinion of the investigator, could affect intestinal transit and microbiota.
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, 210002
Ning Li, MD, +86-25-80860089, jinlingh_lining@126.com
Jianfeng Gong, MD
About this study
Official title: Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation: a Randomized Controlled Study
The purpose of this study is to compare the effect of freeze-dried, capsulized FMT and fresh FMT in adults with slow transit constipation.
Read the detailed description
Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide general population. Constipation frequency appears to augment with increasing age, particularly after 65 years old.
Recent evidence in the literature and collected in the investigators' laboratory confirm that constipation can be a consequence of intestinal dysbiosis, with an increase of potentially pathogenic microorganisms and a decrease of potentially beneficial microorganisms. These alterations may affect the motility and metabolic environment of colon, especially the production of short chain fatty acids (SCFAs).
A new and under-explored method to manipulate the gastrointestinal microbiota involves fecal microbiota transplantation (FMT). There has been growing interest in the use of fecal microbiota for the treatment of patients with chronic gastrointestinal infections (e.g. CDI) and other extraintestinal conditions (e.g. IBD). Similarly, the investigators suppose that reshaping the gut microbiome with FMT would be effective for patients with slow transit constipation.
- Conditions
- Slow Transit Constipation
- Being tested
- Freeze-dried, Capsulized FMT, Fresh FMT
- Keywords
- Slow Transit Constipation, Freeze-dried, Capsulized FMT, Fresh FMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried, Capsulized FMTProcedure or surgery
Fresh FMTProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Freeze-dried, Capsulized FMT | Experimental | Patients included will receive bowel lavage and subsequent Freeze-dried, Capsulized FMT, and then will be followed up for 3 months. Receives: Procedure: Freeze-dried, Capsulized FMT |
| Fresh FMT | Experimental | Patients included will receive bowel lavage and subsequent Fresh FMT, and then will be followed up for 3 months. Receives: Procedure: Fresh FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients having on average three or more SCBMs/week
Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at week 4 and 12.
Measured: 3 months
Secondary outcomes (7)
Mean number of bowel movements per week
Patients kept daily diaries about times of bowel movements each day.
Measured: 3 months
Characteristics of bowel movements
Patients kept daily diaries about stool consistency and degree of straining severity during defecation.
Measured: 3 months
Constipation-related symptoms assessments
Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4 and 12.
Measured: 3 months
Quality-of-Life assessments
Quality-of-Life was evaluated using the validated Patient Assessment of Constipation Quality of Life (PAC-QOL) self-report questionnaire at week 4 and 12.
Measured: 3 months
Colonic transit time measurements
Colonic transit time (CTT) was measured at week 4 and 12 with the Metcalf method.
Measured: 3 months
Usage of laxatives or enemas as rescue medication
If patients did not have a bowel movement for 3 or more consecutive days, they were permitted to take up to 20 g of Macrogol 4000 powder (Forlax). If ineffective, enema was used. Patients kept daily diaries about the rescue medication when used.
Measured: 3 months
Adverse events
Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Slow Transit 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Gong, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676388
- Sponsor's protocol ID
- Freeze-dried FMT-STC
- Status last verified
- Mar 2016
- First submitted
- 3 Feb 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02676388
- Acronym / sponsor ID
- Freeze-dried FMT-STC
- Conditions
- Slow Transit Constipation
- Keywords
- Slow Transit Constipation, Freeze-dried, Capsulized FMT, Fresh FMT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 8 Feb 2016 (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.
The purpose of this study is to compare the effect of freeze-dried, capsulized FMT and fresh FMT in adults with slow transit constipation.
Detailed description
Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide general population. Constipation frequency appears to augment with increasing age, particularly after 65 years old.
Recent evidence in the literature and collected in the investigators' laboratory confirm that constipation can be a consequence of intestinal dysbiosis, with an increase of potentially pathogenic microorganisms and a decrease of potentially beneficial microorganisms. These alterations may affect the motility and metabolic environment of colon, especially the production of short chain fatty acids (SCFAs).
A new and under-explored method to manipulate the gastrointestinal microbiota involves fecal microbiota transplantation (FMT). There has been growing interest in the use of fecal microbiota for the treatment of patients with chronic gastrointestinal infections (e.g. CDI) and other extraintestinal conditions (e.g. IBD). Similarly, the investigators suppose that reshaping the gut microbiome with FMT would be effective for patients with slow transit constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freeze-dried, Capsulized FMT | Experimental | Procedure: Freeze-dried, Capsulized FMTPatients included will receive bowel lavage and subsequent Freeze-dried, Capsulized FMT, and then will be followed up for 3 months. |
| Fresh FMT | Experimental | Procedure: Fresh FMTPatients included will receive bowel lavage and subsequent Fresh FMT, and then will be followed up for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Chronic constipation according to Rome III criteria, defined as two or fewer spontaneous, complete bowel movements (SCBMs) per week for a minimum of 6 months;
- Age ≥ 18 years;
- BMI: 18.5-25 kg/m2;
- Slow colonic transit confirmed by colonic transit test (colonic transit time (CTT) > 48 hours);
- Normal anorectal manometry, with no evidence of dyssynergia and confirmed ability to expel rectal balloon;
Key exclusion criteria (12 listed)
- Bowel constipation due to innate factor (i.e. megacolon) or secondary interventions (i.e. drugs, endocrine, metabolic, neurologic or psychologic disorders);
- History or evidence of gastrointestinal diseases (i.e. obstruction, cancer, inflammatory bowel diseases) ;
- Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
- Previous proctological or perianal surgery;
- A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;
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 |
|---|---|---|
| Freeze-dried, Capsulized FMT | Procedure or surgery | Freeze-dried, Capsulized FMT |
| Fresh FMT | Procedure or surgery | Fresh FMT |
Primary outcome
Proportion of patients having on average three or more SCBMs/week
Time frame: 3 months
Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at week 4 and 12.
7 secondary outcomes
Mean number of bowel movements per week
Time frame: 3 months
Characteristics of bowel movements
Time frame: 3 months
Constipation-related symptoms assessments
Time frame: 3 months
Quality-of-Life assessments
Time frame: 3 months
Colonic transit time measurements
Time frame: 3 months
Usage of laxatives or enemas as rescue medication
Time frame: 3 months
Adverse events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Freeze-dried, Capsulized FMT and Fresh FMT in people with Slow Transit Constipation, run by Jinling Hospital, China 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 8 inclusion and 12 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 15 Mar 2016. 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.
What does this phase mean?
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 Jianfeng Gong, MD (+86-25-80860036, jinlingh_gongjf@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients having on average three or more SCBMs/week (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 15 Mar 2016.