Effect of Fecal Microbiota Transplantation in Slow Transit Constipation (FMTSTC)
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|ClinicalTrials.gov Identifier: NCT02301221|
Recruitment Status : Unknown
Verified November 2016 by Jianfeng Gong, Jinling Hospital, China.
Recruitment status was: Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : November 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Slow Transit Constipation||Procedure: Fecal microbiota transplantation (FMT) Drug: Vancomycin and bowel lavage||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Fecal microbiota transplantation (FMT)
Patients included will receive standard FMT, and then will be followed up for 24 weeks.
Procedure: Fecal microbiota transplantation (FMT)
Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
Other Name: Fecal bacteriotherapy
Drug: Vancomycin and bowel lavage
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.
- Proportion of patients having on average three or more SCBMs/week [ Time Frame: 24 weeks ]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.
- Bowel habit assessments [ Time Frame: 24 weeks ]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.
- Constipation-related symptoms assessments [ Time Frame: 24 weeks ]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.
- Quality-of-Life assessments [ Time Frame: 24 weeks ]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.
- Colonic transit time measurements [ Time Frame: 24 weeks ]Colonic transit time (CTT) was measured at baseline and at week 4, 12 and 24 with the Metcalf method.
- Usage of laxatives or enemas as rescue medication [ Time Frame: 24 weeks ]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.
- Adverse events [ Time Frame: 24 weeks ]Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301221
|Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University|
|Nanjing, Jiangsu, China, 210002|
|Study Director:||Ning Li, MD||Department of Generay Surgery, Jinling hosptal|