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Effect of Fecal Microbiota Transplantation in 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

Official(s) and/or principal investigator(s):
Ning Li, MD, Study Director, Affiliation: Department of Generay Surgery, Jinling hosptal

Overall contact:
Jianfeng Gong, MD, Phone: +86-25-80860036, Email: gongjianfeng@aliyun.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 Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of patients having on average three or more SCBMs/week

Secondary outcome:

Bowel habit assessments

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 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.

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: gongjianfeng@aliyun.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: liningrigs@vip.sina.com
Jianfeng Gong, MD, Principal Investigator
Chao Ding, MD candidate, Sub-Investigator
Hongliang Tian, PhD candidate, Sub-Investigator
Xiaolong Ge, MD candidate, Sub-Investigator
Additional Information

Starting date: July 2014
Last updated: August 15, 2015

Page last updated: August 23, 2015

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