Efficacy and Safety of Fecal Microbiota Transplantation for Slow Transit Constipation
Information source: Jinling Hospital, China
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Slow Transit Constipation
Intervention: Fecal microbiota transplantation (FMT) (Procedure); Vancomycin and bowel lavage (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Jinling Hospital, China Overall contact: Jianfeng Gong, MD, Phone: +86-25-80860036, Email: jinlingh_gongjf@126.com
Summary
The purpose of this study is to evaluate the effect of fecal microbiota transplantation in
adults with slow transit constipation.
Clinical Details
Official title: A Randomized Controlled Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Proportion of patients having on average three or more SCBMs/week
Secondary outcome: Mean number of bowel movements per weekCharacteristics of bowel movements Constipation-related symptoms assessments Quality-of-Life assessments Colonic transit time measurements Change of fecal bacteriology Change of fecal SCFAs Usage of laxatives or enemas as rescue medication Adverse events
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 transit constipation confirmed by colonic transit test (colonic transit time
(CTT) > 48 hours);
- Disease duration > 1 year;
- Traditional treatment with diet, laxatives (including osmotic and stimulant
laxatives), enemas, 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;
- Rectal prolapse and/or grade 3-4 internal hemorrhoids according to AGA
classification;
- Severe anterior rectocele and/or full thickness rectorectal intussusception according
to defecography;
- Pathological rectoanal pressure gradients and/or electromyographic inhibition pattern
of the external anal sphincter during straining according to manometric and/or
electromyographic evidence;
- 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.
Locations and Contacts
Jianfeng Gong, MD, Phone: +86-25-80860036, Email: jinlingh_gongjf@126.com
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University, Nanjing, Jiangsu 210002, China; Recruiting Ning Li, MD, Phone: +86-25-80860089, Email: jinlingh_lining@126.com Jianfeng Gong, MD, Principal Investigator Chao Ding, MD candidate, Sub-Investigator
Additional Information
Starting date: June 2015
Last updated: August 15, 2015
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