- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02301221
Effect of Fecal Microbiota Transplantation in Slow Transit Constipation (FMTSTC)
A Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
Study Overview
Status
Conditions
Intervention / Treatment
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 our 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, we suppose that reshaping the gut microbiome with FMT would be effective for patients with slow transit constipation.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210002
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fecal microbiota transplantation (FMT)
Patients included will receive standard FMT, and then will be followed up for 24 weeks.
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Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
Other Names:
An initial vancomycin regimen (500 mg orally two times per day for 3 days), followed by bowel lavage before the infusion of a solution of donor fecal microbiota.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients having on average three or more SCBMs/week
Time Frame: 24 weeks
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Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at baseline and over the week interval 3-4, 9-12 and 21-24.
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bowel habit assessments
Time Frame: 24 weeks
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Patients kept daily diaries about times of bowel movements each day, stool consistency, degree of straining severity during defecation, and degree of sensation of incompleteness of evacuation.
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24 weeks
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Constipation-related symptoms assessments
Time Frame: 24 weeks
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Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at baseline and at week 4, 12, and 24.
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24 weeks
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Quality-of-Life assessments
Time Frame: 24 weeks
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Quality-of-Life was evaluated using the validated Patient Assessment of Constipation Quality of Life (PAC-QOL) self-report questionnaire at baseline and at week 4, 12, and 24.
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24 weeks
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Colonic transit time measurements
Time Frame: 24 weeks
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Colonic transit time (CTT) was measured at baseline and at week 4, 12 and 24 with the Metcalf method.
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24 weeks
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Usage of laxatives or enemas as rescue medication
Time Frame: 24 weeks
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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 were used.
Patients kept daily diaries about the rescue medication when used.
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24 weeks
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Adverse events
Time Frame: 24 weeks
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Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.
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24 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIGS-FMT-STC-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Slow Transit Constipation
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Jinling Hospital, ChinaUnknownSlow Transit ConstipationChina
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Jinling Hospital, ChinaUnknownSlow Transit ConstipationChina
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Jinling Hospital, ChinaCompleted
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Jinling Hospital, ChinaUnknownSlow Transit ConstipationChina
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Jinling Hospital, ChinaUnknownSlow Transit ConstipationChina
-
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University of British ColumbiaCompleted
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Susy HotaSinai Health System, Ontario, Canada; University of Toronto, Ontario, Canada; The Toronto Invasive Bacterial Diseases Network, Ontario, Canada and other collaboratorsSuspended
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Brigham and Women's HospitalIcahn School of Medicine at Mount Sinai; The Miriam Hospital; Indiana UniversityCompletedInflammatory Bowel Diseases | Clostridium Difficile InfectionUnited States
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