The purpose of this study is to evaluate the effect of fecal microbiota transplantation in adults with slow transit constipation.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
Conventional treatment was taken by both of two groups. 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®, Ipsen, Paris, France). If ineffective, an enema could be used.
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China
RECRUITINGProportion 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.
Time frame: 3 months
Mean number of bowel movements per week
Patients kept daily diaries about times of bowel movements each day.
Time frame: 3 months
Characteristics of bowel movements
Patients kept daily diaries about stool consistency and degree of straining severity during defecation.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Colonic transit time measurements
Colonic transit time (CTT) was measured at week 4 and 12 with the Metcalf method.
Time frame: 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.
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Time frame: 3 months
Adverse events
Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.
Time frame: 3 months